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Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00363415
Collaborator
(none)
908
Enrollment
190
Locations
2
Arms
22
Duration (Months)
4.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer. Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin. It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
908 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
  • LY231514
  • Alimta

    • Drug: carboplatin
    Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Active Comparator: B

    Drug: etoposide
    100 mg/m2, intravenous (IV), days 1-3 x 6 cycles

    Drug: carboplatin
    Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [baseline to date of death from any cause (up to 19.6 months)]

      Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

    Secondary Outcome Measures

    1. Overall Survival (Subgroups) [baseline to date of death from any cause (up to 19.6 months)]

      The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.

    2. Progression Free Survival [baseline to measured progressive disease (up to 14.7 months)]

      The period from study entry until disease progression, death or date of last contact.

    3. Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L) [baseline and 6 cycles (21-day cycles)]

      FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.

    4. Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes) [baseline to date of death due to any cause (up to 19.6 months)]

      The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of extensive stage small cell lung cancer (SCLC)

    • Capable of self-care but may be unable to carry out any work activities.

    • No prior anticancer therapy for SCLC

    Exclusion Criteria:

    • have previously participated in a study involving pemetrexed

    • have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Huntsville Alabama United States 35805
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Anchorage Alaska United States 99508
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fayetteville Arkansas United States 72703
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Burbank California United States 91505
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. La Jolla California United States 92093
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90095
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mission Hills California United States 91345
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orange California United States 92868
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poway California United States 92064
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Myers Florida United States 33916
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jacksonville Florida United States 32256
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Miami Florida United States 33136
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orlando Florida United States 32806
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chicago Illinois United States 60637
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Springfield Illinois United States 62701
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wichita Kansas United States 67214
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lexington Kentucky United States 40536
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Louisville Kentucky United States 40402
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Scarborough Maine United States 04074
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Boston Massachusetts United States 02118
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Detroit Michigan United States 48201
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Minneapolis Minnesota United States 55455
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kansas City Missouri United States 64111
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St Louis Missouri United States 63110
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lincoln Nebraska United States 68510
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sparta New Jersey United States 07871
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Albuquerque New Mexico United States 87106
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Santa Fe New Mexico United States 87505
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chapel Hill North Carolina United States 27599
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Concord North Carolina United States 28025
    31 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati Ohio United States 45267
    32 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbus Ohio United States 43221
    33 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zanesville Ohio United States 43701
    34 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Portland Oregon United States 97213
    35 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dunmore Pennsylvania United States 18512
    36 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. East Stroudsburg Pennsylvania United States 18301
    37 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ephrata Pennsylvania United States 17522
    38 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Media Pennsylvania United States 19063
    39 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Philadelphia Pennsylvania United States 19141
    40 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wilkes-Barre Pennsylvania United States 18711
    41 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charleston South Carolina United States 29406
    42 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Columbia South Carolina United States 29210
    43 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chattanooga Tennessee United States 37404
    44 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Knoxville Tennessee United States 37920
    45 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Memphis Tennessee United States 38120
    46 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Nashville Tennessee United States 37203
    47 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Austin Texas United States 78705
    48 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Dallas Texas United States 75237
    49 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Worth Texas United States 76104
    50 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Houston Texas United States 77060
    51 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Antonio Texas United States 78258
    52 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Richmond Virginia United States 23298
    53 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Everett Washington United States 98201
    54 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madison Wisconsin United States 53792
    55 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bahia Blanca Argentina
    56 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Buenos Aires Argentina 1427
    57 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mar Del Plata Argentina 7600
    58 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rosario Argentina 2000
    59 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Tucumain Argentina 4000
    60 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Camperdown New South Wales Australia 2050
    61 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coffs Harbour New South Wales Australia 2450
    62 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Port Macquarie New South Wales Australia 2444
    63 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wollongong New South Wales Australia 2500
    64 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brisbane Queensland Australia 4029
    65 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chermisdie Queensland Australia 4032
    66 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Redcliffe Queensland Australia 4020
    67 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. South Brisbane Queensland Australia 4101
    68 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Townsville Queensland Australia 4810
    69 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Adelaide South Australia Australia 5000
    70 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Woodville South Australia Australia 5011
    71 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hobart Tasmania Australia 7001
    72 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Frankston Victoria Australia 3199
    73 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Geelong Victoria Australia 3220
    74 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wodonga Victoria Australia 3690
    75 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Graz Austria 8036
    76 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Linz Austria A-4010
    77 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wien Austria A-1140
    78 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brussels Belgium 1090
    79 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Edegem Belgium 2650
    80 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Leuven Belgium 3000
    81 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Liege Belgium 4000
    82 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Liège Belgium 4000
    83 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Florianópolis Brazil 88034000
    84 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fortaleza Brazil 60430-230
    85 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jau Brazil 17210-120
    86 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sao Paulo Brazil 01277-900
    87 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beijing China 100021
    88 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guang Zhou China 510080
    89 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Shanghai China 200433
    90 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Brest France 29609
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    120 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zalaegerszeg Hungary 8900
    121 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ahmedabad India 380016
    122 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bangalore India 560027
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    125 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mumbai India 400 012
    126 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Delhi India 110029
    127 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Pune India 411001
    128 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Trivandrum India 695 011
    129 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bergamo Italy 24128
    130 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Livorno Italy 57128
    131 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Monteforte Irpino Italy 83024
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    134 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Ravenna Italy 48020
    135 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rome Italy 00149
    136 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Sisto Italy 06156
    137 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seoul Korea, Republic of 138-736
    138 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Amsterdam Netherlands 1081 HV
    139 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Arnhem Netherlands 6815 AD
    140 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Den Bosch Netherlands 5211 NL
    141 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Groningen Netherlands 9713 GZ
    142 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Harderwijk Netherlands 3844 DG
    143 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Heerlen Netherlands 4619 PC
    144 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Auckland New Zealand 1030
    145 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Christchurch New Zealand 8020
    146 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wellington New Zealand 6002
    147 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gdansk Poland 80-211
    148 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Krakow-Nowa Huta Poland PL-31-826
    149 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Otwock Poland 05-400
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    151 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zabrze-Biskupice Poland 41-803
    152 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Coimbra Portugal 3040-853
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    157 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Juan Puerto Rico 00921
    158 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bucharest Romania 022328
    159 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cluj-Napoca Romania 3400
    160 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chelyabinsk Russian Federation 454087
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    162 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Kazan Russian Federation 420029
    163 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Murmansk Russian Federation 183047
    164 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint Petersburg Russian Federation 198255
    165 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Stavropol Russian Federation 355047
    166 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cape Town South Africa 7925
    167 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durban South Africa 4091
    168 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parktown South Africa 2193
    169 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Alicante Spain 03010
    170 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Badalona Spain 08915
    171 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barakaldo Spain 48903
    172 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona Spain 08907
    173 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid Spain 28041
    174 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zaragoza Spain 50009
    175 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Niao Sung Hsiang Taiwan 833
    176 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taichung Taiwan 407
    177 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Taipei Taiwan 100
    178 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Besevler/Ankara Turkey 06500
    179 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gaziantep Turkey
    180 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Istanbul Turkey 34760
    181 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Izmir Turkey 35100
    182 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Samsun Turkey 55139
    183 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Bristol Avon United Kingdom BS2 8ED
    184 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Truro Cornwall United Kingdom TR1 3LJ
    185 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Chelmsford Essex United Kingdom CM1 7ET
    186 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Aberdeen Scotland United Kingdom AB25 2ZN
    187 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Glasgow Scotland United Kingdom G12 0YN
    188 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Birmingham West Midlands United Kingdom B15 2TH
    189 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wolverhampton West Midlands United Kingdom WV10 0QP
    190 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00363415
    Other Study ID Numbers:
    • 9691
    • H3E-MC-JMHO
    First Posted:
    Aug 15, 2006
    Last Update Posted:
    Oct 28, 2009
    Last Verified:
    Oct 1, 2009
    Additional relevant MeSH terms:
    Lung Neoplasms
    Small Cell Lung Carcinoma
    Carboplatin
    Etoposide
    Pemetrexed

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Participants who received at least one dose of study drug were, per protocol, the patient population used for the summary of safety data (eg, Serious Adverse Events).
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Period Title: Overall Study
    STARTED 453 455
    Received at Least One Dose of Study Drug 433 447
    COMPLETED 92 206
    NOT COMPLETED 361 249

    Baseline Characteristics

    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin Total
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Total of all reporting groups
    Overall Participants 453 455 908
    Age, Customized (participants) [Number]
    <=65 years
    267
    58.9%
    275
    60.4%
    542
    59.7%
    >65 years
    186
    41.1%
    180
    39.6%
    366
    40.3%
    Sex: Female, Male (Count of Participants)
    Female
    128
    28.3%
    125
    27.5%
    253
    27.9%
    Male
    325
    71.7%
    330
    72.5%
    655
    72.1%
    Region of Enrollment (participants) [Number]
    United States
    92
    20.3%
    83
    18.2%
    175
    19.3%
    Portugal
    9
    2%
    7
    1.5%
    16
    1.8%
    Taiwan
    11
    2.4%
    12
    2.6%
    23
    2.5%
    Greece
    7
    1.5%
    8
    1.8%
    15
    1.7%
    Spain
    16
    3.5%
    21
    4.6%
    37
    4.1%
    Russian Federation
    30
    6.6%
    16
    3.5%
    46
    5.1%
    Italy
    7
    1.5%
    8
    1.8%
    15
    1.7%
    India
    12
    2.6%
    14
    3.1%
    26
    2.9%
    France
    19
    4.2%
    10
    2.2%
    29
    3.2%
    Australia
    21
    4.6%
    19
    4.2%
    40
    4.4%
    South Africa
    0
    0%
    1
    0.2%
    1
    0.1%
    Netherlands
    17
    3.8%
    17
    3.7%
    34
    3.7%
    China
    14
    3.1%
    18
    4%
    32
    3.5%
    Korea, Republic of
    17
    3.8%
    15
    3.3%
    32
    3.5%
    Turkey
    15
    3.3%
    13
    2.9%
    28
    3.1%
    Austria
    5
    1.1%
    14
    3.1%
    19
    2.1%
    United Kingdom
    16
    3.5%
    18
    4%
    34
    3.7%
    Hungary
    19
    4.2%
    13
    2.9%
    32
    3.5%
    Argentina
    2
    0.4%
    6
    1.3%
    8
    0.9%
    Belgium
    12
    2.6%
    17
    3.7%
    29
    3.2%
    Brazil
    4
    0.9%
    7
    1.5%
    11
    1.2%
    Poland
    29
    6.4%
    34
    7.5%
    63
    6.9%
    Romania
    20
    4.4%
    23
    5.1%
    43
    4.7%
    Germany
    58
    12.8%
    59
    13%
    117
    12.9%
    New Zealand
    1
    0.2%
    2
    0.4%
    3
    0.3%
    Eastern Cooperative Oncology Group Performance Status (participants) [Number]
    0 - Fully Active
    133
    29.4%
    121
    26.6%
    254
    28%
    1 - Ambulatory, Restricted Strenuous Activity
    265
    58.5%
    277
    60.9%
    542
    59.7%
    2 - Ambulatory, No Work Activities
    54
    11.9%
    55
    12.1%
    109
    12%
    3 - Partially Confined to Bed, Limited Self Care
    1
    0.2%
    0
    0%
    1
    0.1%
    Not Reported
    0
    0%
    2
    0.4%
    2
    0.2%
    History of Brain Metastases (participants) [Number]
    No
    410
    90.5%
    412
    90.5%
    822
    90.5%
    Yes
    43
    9.5%
    41
    9%
    84
    9.3%
    Not Reported
    0
    0%
    2
    0.4%
    2
    0.2%
    Race/Ethnicity (participants) [Number]
    Caucasian
    391
    86.3%
    379
    83.3%
    770
    84.8%
    East Asian
    43
    9.5%
    49
    10.8%
    92
    10.1%
    West Asian
    12
    2.6%
    12
    2.6%
    24
    2.6%
    African
    5
    1.1%
    8
    1.8%
    13
    1.4%
    Hispanic
    1
    0.2%
    5
    1.1%
    6
    0.7%
    Aboriginal and/or Torres Strait Islander
    0
    0%
    2
    0.4%
    2
    0.2%
    Native American
    1
    0.2%
    0
    0%
    1
    0.1%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
    Time Frame baseline to date of death from any cause (up to 19.6 months)

    Outcome Measure Data

    Analysis Population Description
    Number of participants with events. In the pemetrexed+carboplatin group, 242 participants were censored. In the etoposide+carboplatin group, 288 participants were censored.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 211 167
    Median (95% Confidence Interval) [months]
    8.1
    10.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.01
    Comments
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.56
    Confidence Interval () 95%
    1.27 to 1.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Overall Survival (Subgroups)
    Description The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported. For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.
    Time Frame baseline to date of death from any cause (up to 19.6 months)

    Outcome Measure Data

    Analysis Population Description
    Number of randomized participants.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 453 455
    Sex: Male (n=325, n=330)
    8.2
    10.4
    Sex: Female (n=128, n=125)
    8.1
    11.6
    Race: Caucasian (n=391, n=379)
    8.2
    11.2
    Race: Non-Caucasian (n=62, n=76)
    7.1
    8.7
    ECOG: 0 or 1 (n=398, n=398)
    8.5
    11.3
    ECOG: 2 (n=54, n=55)
    6.2
    5.2
    Region: United States (n=92, n=83)
    8.1
    11.3
    Region: European Union (n=279, n=278)
    8.5
    11.2
    Region: Intercontinential Region (n=82, n=94)
    7.2
    9.9
    LDH: >Upper Limit of Normal (n=276, n=273)
    7.2
    9.3
    Age: <= 65 years (n=267, n=275)
    8.4
    11.5
    Age: >65 years (n=186, n=180)
    7.7
    9.7
    Number Metastatic Sites: <=2 (n=172, n=204)
    10.0
    11.5
    Number Metastatic Sites: >=3 (n=273, n=246)
    7.7
    10.3
    History of Brain Metastases: No (n=410, n=412)
    8.2
    10.6
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Sex: Male
    Method Log Rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.023
    Comments P-value for Sex: Female
    Method Log Rank
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Race: Caucasian.
    Method Log Rank
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.030
    Comments P-value for Race: Non-Caucasian.
    Method Log Rank
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.
    Method Log Rank
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.519
    Comments P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.
    Method Log Rank
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.084
    Comments P-value for Region: United States.
    Method Log Rank
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments P-value for Region: European Union.
    Method Log Rank
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments P-value for Region: Intercontinental Region.
    Method Log Rank
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments P-value for LDH (lactate dehydrogenase): >Upper Limit of Normal.
    Method Log Rank
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Age: <=65 years.
    Method Log Rank
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments P-value for Age: >65 years.
    Method Log Rank
    Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.092
    Comments P-value for Number Metastatic Sites: <=2.
    Method Log Rank
    Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for Number Metastatic Sites: >=3.
    Method Log Rank
    Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection Pemetrexed + Carboplatin, Etoposide + Carboplatin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments P-value for History of Brain Metastases: No.
    Method Log Rank
    Comments
    3. Secondary Outcome
    Title Progression Free Survival
    Description The period from study entry until disease progression, death or date of last contact.
    Time Frame baseline to measured progressive disease (up to 14.7 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Number of participants censored: 113 in Pemetrexed+Carboplatin; 150 in Etoposide+Carboplatin.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 453 455
    Median (95% Confidence Interval) [months]
    3.8
    5.4
    4. Secondary Outcome
    Title Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
    Description FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer. Total scores range from 0 to 136, with higher scores representing better HR-QL. A clinically meaningful change is considered to be 5 points.
    Time Frame baseline and 6 cycles (21-day cycles)

    Outcome Measure Data

    Analysis Population Description
    Number of randomized participants with baseline and non-missing value at respective cycle.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 384 383
    Baseline (n=384, n=383)
    87.42
    (15.40)
    87.79
    (16.63)
    Cycle 1 Change from Baseline (n=270, n=275)
    -0.22
    (12.48)
    1.55
    (11.11)
    Cycle 2 Change from Baseline (n=283, n=310)
    0.17
    (13.72)
    1.73
    (12.73)
    Cycle 3 Change from Baseline (n=225, n=277)
    0.06
    (14.61)
    1.70
    (13.98)
    Cycle 4 Change from Baseline (n=199, n=259)
    -0.14
    (15.28)
    1.69
    (13.42)
    Cycle 5 Change from Baseline (n=140, n=203)
    0.27
    (16.34)
    1.94
    (14.06)
    Cycle 6 Change from Baseline (n=98, n=146)
    0.34
    (17.56)
    3.73
    (14.97)
    5. Secondary Outcome
    Title Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)
    Description The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported. The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group. The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.
    Time Frame baseline to date of death due to any cause (up to 19.6 months)

    Outcome Measure Data

    Analysis Population Description
    The upper limit of the 95% Confidence Intervals (CI) were not calculable for these two subgroups in the etoposide+carboplatin group so medians and lower limits of the 95% CI are not presented. A post-hoc outcome measure table provides the number of participants in each subgroup.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 0 0
    6. Post-Hoc Outcome
    Title Number of Participants in Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes
    Description Number of participants with Low Density Lipoprotein <=upper limit of normal and the number of participants with a history of brain metastases. This post-hoc outcome replaces the one for Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes).
    Time Frame baseline to date of death due to any cause (up to 19.6 months)

    Outcome Measure Data

    Analysis Population Description
    Number of randomized participants.
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
    Measure Participants 453 455
    LDH: <=Upper Limit of Normal
    167
    36.9%
    169
    37.1%
    History of Brain Metastases: Yes
    43
    9.5%
    41
    9%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Pemetrexed + Carboplatin Etoposide + Carboplatin
    Arm/Group Description Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug) Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles. (Participants who received at least one dose of study drug)
    All Cause Mortality
    Pemetrexed + Carboplatin Etoposide + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Pemetrexed + Carboplatin Etoposide + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 150/ (NaN) 134/ (NaN)
    Blood and lymphatic system disorders
    Agranulocytosis 0/433 (0%) 0 1/447 (0.2%) 1
    Anaemia 18/433 (4.2%) 20 7/447 (1.6%) 7
    Bone marrow failure 1/433 (0.2%) 1 0/447 (0%) 0
    Febrile neutropenia 7/433 (1.6%) 8 14/447 (3.1%) 14
    Leukopenia 4/433 (0.9%) 4 4/447 (0.9%) 4
    Neutropenia 11/433 (2.5%) 12 19/447 (4.3%) 21
    Splenic infarction 2/433 (0.5%) 2 0/447 (0%) 0
    Thrombocytopenia 15/433 (3.5%) 18 7/447 (1.6%) 8
    Cardiac disorders
    Acute coronary syndrome 1/433 (0.2%) 1 0/447 (0%) 0
    Acute left ventricular failure 1/433 (0.2%) 1 0/447 (0%) 0
    Acute myocardial infarction 1/433 (0.2%) 1 1/447 (0.2%) 1
    Angina pectoris 1/433 (0.2%) 1 1/447 (0.2%) 1
    Angina unstable 0/433 (0%) 0 2/447 (0.4%) 2
    Atrial fibrillation 5/433 (1.2%) 5 0/447 (0%) 0
    Atrial flutter 1/433 (0.2%) 1 0/447 (0%) 0
    Cardiac arrest 2/433 (0.5%) 2 1/447 (0.2%) 1
    Cardiac failure 2/433 (0.5%) 2 0/447 (0%) 0
    Cardiac failure acute 1/433 (0.2%) 1 0/447 (0%) 0
    Cardiac failure congestive 1/433 (0.2%) 1 1/447 (0.2%) 1
    Cardiac fibrillation 1/433 (0.2%) 1 0/447 (0%) 0
    Cardio-respiratory arrest 2/433 (0.5%) 2 1/447 (0.2%) 1
    Coronary artery insufficiency 1/433 (0.2%) 1 0/447 (0%) 0
    Left ventricular dysfunction 1/433 (0.2%) 1 0/447 (0%) 0
    Myocardial infarction 4/433 (0.9%) 4 1/447 (0.2%) 1
    Myocardial ischaemia 1/433 (0.2%) 1 0/447 (0%) 0
    Supraventricular tachycardia 1/433 (0.2%) 1 0/447 (0%) 0
    Ventricular fibrillation 1/433 (0.2%) 1 0/447 (0%) 0
    Congenital, familial and genetic disorders
    Tracheo-oesophageal fistula 1/433 (0.2%) 1 0/447 (0%) 0
    Ear and labyrinth disorders
    Vertigo 1/433 (0.2%) 1 0/447 (0%) 0
    Endocrine disorders
    Inappropriate antidiuretic hormone secretion 1/433 (0.2%) 1 2/447 (0.4%) 2
    Eye disorders
    Eyelid ptosis 0/433 (0%) 0 1/447 (0.2%) 1
    Retinal detachment 1/433 (0.2%) 1 0/447 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 4/433 (0.9%) 4 1/447 (0.2%) 1
    Abdominal pain upper 2/433 (0.5%) 2 2/447 (0.4%) 2
    Colitis 2/433 (0.5%) 2 0/447 (0%) 0
    Constipation 4/433 (0.9%) 4 4/447 (0.9%) 4
    Diarrhoea 11/433 (2.5%) 11 3/447 (0.7%) 3
    Duodenal ulcer perforation 0/433 (0%) 0 1/447 (0.2%) 1
    Dysphagia 3/433 (0.7%) 3 1/447 (0.2%) 1
    Gastric ulcer 1/433 (0.2%) 1 0/447 (0%) 0
    Gastritis 0/433 (0%) 0 1/447 (0.2%) 1
    Gastroduodenal ulcer 1/433 (0.2%) 1 0/447 (0%) 0
    Gastrointestinal haemorrhage 1/433 (0.2%) 1 0/447 (0%) 0
    Nausea 15/433 (3.5%) 18 2/447 (0.4%) 2
    Oesophageal stenosis 0/433 (0%) 0 2/447 (0.4%) 2
    Oral discomfort 1/433 (0.2%) 1 0/447 (0%) 0
    Pancreatitis acute 0/433 (0%) 0 2/447 (0.4%) 2
    Proctitis 1/433 (0.2%) 1 0/447 (0%) 0
    Small intestinal obstruction 1/433 (0.2%) 1 0/447 (0%) 0
    Vomiting 11/433 (2.5%) 11 4/447 (0.9%) 4
    General disorders
    Asthenia 4/433 (0.9%) 4 2/447 (0.4%) 2
    Chest discomfort 0/433 (0%) 0 1/447 (0.2%) 1
    Chest pain 4/433 (0.9%) 4 4/447 (0.9%) 4
    Condition aggravated 0/433 (0%) 0 1/447 (0.2%) 1
    Fatigue 3/433 (0.7%) 3 2/447 (0.4%) 2
    General physical health deterioration 1/433 (0.2%) 1 0/447 (0%) 0
    Malaise 2/433 (0.5%) 2 0/447 (0%) 0
    Mucosal inflammation 0/433 (0%) 0 1/447 (0.2%) 1
    Pain 1/433 (0.2%) 1 0/447 (0%) 0
    Performance status decreased 0/433 (0%) 0 2/447 (0.4%) 2
    Pyrexia 3/433 (0.7%) 3 5/447 (1.1%) 6
    Sudden death 0/433 (0%) 0 1/447 (0.2%) 1
    Visceral oedema 0/433 (0%) 0 1/447 (0.2%) 1
    Hepatobiliary disorders
    Hepatic failure 0/433 (0%) 0 1/447 (0.2%) 1
    Hepatic pain 1/433 (0.2%) 1 0/447 (0%) 0
    Immune system disorders
    Anaphylactic shock 1/433 (0.2%) 1 0/447 (0%) 0
    Drug hypersensitivity 0/433 (0%) 0 1/447 (0.2%) 1
    Hypersensitivity 0/433 (0%) 0 1/447 (0.2%) 1
    Infections and infestations
    Bacterial sepsis 0/433 (0%) 0 1/447 (0.2%) 1
    Bronchopneumonia 1/433 (0.2%) 1 1/447 (0.2%) 1
    Candidiasis 0/433 (0%) 0 1/447 (0.2%) 1
    Catheter related infection 1/433 (0.2%) 1 0/447 (0%) 0
    Cellulitis 0/433 (0%) 0 1/447 (0.2%) 1
    Device related infection 0/433 (0%) 0 1/447 (0.2%) 1
    Diverticulitis 1/433 (0.2%) 1 1/447 (0.2%) 1
    Empyema 3/433 (0.7%) 3 2/447 (0.4%) 3
    Encephalitis herpes 0/433 (0%) 0 1/447 (0.2%) 1
    Enteritis infectious 1/433 (0.2%) 1 0/447 (0%) 0
    Febrile infection 0/433 (0%) 0 1/447 (0.2%) 1
    Gastroenteritis 1/433 (0.2%) 1 0/447 (0%) 0
    Herpes zoster 0/433 (0%) 0 1/447 (0.2%) 1
    Infection 1/433 (0.2%) 1 0/447 (0%) 0
    Klebsiella sepsis 1/433 (0.2%) 1 0/447 (0%) 0
    Lower respiratory tract infection 2/433 (0.5%) 2 0/447 (0%) 0
    Lung abscess 0/433 (0%) 0 1/447 (0.2%) 1
    Lung infection 2/433 (0.5%) 2 0/447 (0%) 0
    Necrotising fasciitis 1/433 (0.2%) 1 0/447 (0%) 0
    Neutropenic sepsis 1/433 (0.2%) 1 2/447 (0.4%) 2
    Pneumonia 20/433 (4.6%) 24 15/447 (3.4%) 16
    Pneumonia necrotising 0/433 (0%) 0 1/447 (0.2%) 1
    Pneumonia primary atypical 1/433 (0.2%) 1 1/447 (0.2%) 1
    Pneumonia staphylococcal 0/433 (0%) 0 1/447 (0.2%) 1
    Pseudomembranous colitis 1/433 (0.2%) 1 0/447 (0%) 0
    Respiratory tract infection 1/433 (0.2%) 1 3/447 (0.7%) 3
    Sepsis 5/433 (1.2%) 5 5/447 (1.1%) 5
    Septic shock 3/433 (0.7%) 3 0/447 (0%) 0
    Staphylococcal infection 0/433 (0%) 0 1/447 (0.2%) 1
    Upper respiratory tract infection 0/433 (0%) 0 2/447 (0.4%) 2
    Urinary tract infection 3/433 (0.7%) 3 3/447 (0.7%) 3
    Wound infection 1/433 (0.2%) 1 0/447 (0%) 0
    Injury, poisoning and procedural complications
    Chest injury 1/433 (0.2%) 2 0/447 (0%) 0
    Drug toxicity 1/433 (0.2%) 1 0/447 (0%) 0
    Fall 1/433 (0.2%) 1 0/447 (0%) 0
    Lung injury 1/433 (0.2%) 1 0/447 (0%) 0
    Overdose 1/433 (0.2%) 1 0/447 (0%) 0
    Poisoning 1/433 (0.2%) 1 0/447 (0%) 0
    Post-traumatic pain 1/433 (0.2%) 1 0/447 (0%) 0
    Investigations
    Blood bilirubin increased 1/433 (0.2%) 1 0/447 (0%) 0
    Blood creatinine increased 2/433 (0.5%) 2 1/447 (0.2%) 1
    Blood urea increased 1/433 (0.2%) 1 0/447 (0%) 0
    C-reactive protein increased 0/433 (0%) 0 1/447 (0.2%) 1
    Platelet count decreased 1/433 (0.2%) 1 1/447 (0.2%) 1
    Weight decreased 0/433 (0%) 0 1/447 (0.2%) 1
    White blood cell count decreased 0/433 (0%) 0 1/447 (0.2%) 1
    Metabolism and nutrition disorders
    Anorexia 2/433 (0.5%) 2 0/447 (0%) 0
    Dehydration 6/433 (1.4%) 6 4/447 (0.9%) 5
    Fluid retention 1/433 (0.2%) 1 0/447 (0%) 0
    Hyperglycaemia 2/433 (0.5%) 2 0/447 (0%) 0
    Hypokalaemia 2/433 (0.5%) 2 0/447 (0%) 0
    Hyponatraemia 6/433 (1.4%) 6 5/447 (1.1%) 5
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/433 (0%) 0 2/447 (0.4%) 2
    Back pain 3/433 (0.7%) 3 1/447 (0.2%) 1
    Bone pain 0/433 (0%) 0 1/447 (0.2%) 1
    Musculoskeletal chest pain 1/433 (0.2%) 1 0/447 (0%) 0
    Neck pain 1/433 (0.2%) 1 0/447 (0%) 0
    Pain in extremity 0/433 (0%) 0 1/447 (0.2%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 1/433 (0.2%) 1 0/447 (0%) 0
    Intracranial tumour haemorrhage 0/433 (0%) 0 1/447 (0.2%) 1
    Malignant neoplasm progression 0/433 (0%) 0 1/447 (0.2%) 1
    Metastases to central nervous system 1/433 (0.2%) 1 0/447 (0%) 0
    Metastatic pain 1/433 (0.2%) 1 0/447 (0%) 0
    Tumour lysis syndrome 1/433 (0.2%) 1 0/447 (0%) 0
    Tumour pain 1/433 (0.2%) 1 0/447 (0%) 0
    Nervous system disorders
    Ataxia 1/433 (0.2%) 1 0/447 (0%) 0
    Carotid artery occlusion 1/433 (0.2%) 1 0/447 (0%) 0
    Cerebral haemorrhage 1/433 (0.2%) 1 0/447 (0%) 0
    Convulsion 2/433 (0.5%) 2 6/447 (1.3%) 6
    Diplegia 1/433 (0.2%) 1 0/447 (0%) 0
    Encephalopathy 1/433 (0.2%) 1 0/447 (0%) 0
    Epilepsy 1/433 (0.2%) 1 0/447 (0%) 0
    Hemiparesis 0/433 (0%) 0 1/447 (0.2%) 1
    Lethargy 1/433 (0.2%) 1 0/447 (0%) 0
    Nervous system disorder 1/433 (0.2%) 1 0/447 (0%) 0
    Speech disorder 0/433 (0%) 0 1/447 (0.2%) 1
    Spinal cord compression 1/433 (0.2%) 1 0/447 (0%) 0
    Transient ischaemic attack 1/433 (0.2%) 1 0/447 (0%) 0
    Unresponsive to stimuli 1/433 (0.2%) 1 0/447 (0%) 0
    Vocal cord paralysis 0/433 (0%) 0 1/447 (0.2%) 1
    Psychiatric disorders
    Confusional state 1/433 (0.2%) 1 2/447 (0.4%) 2
    Insomnia 1/433 (0.2%) 1 1/447 (0.2%) 1
    Panic attack 1/433 (0.2%) 1 0/447 (0%) 0
    Tobacco withdrawal symptoms 1/433 (0.2%) 1 0/447 (0%) 0
    Renal and urinary disorders
    Haematuria 0/433 (0%) 0 1/447 (0.2%) 1
    Renal failure 5/433 (1.2%) 5 1/447 (0.2%) 1
    Renal failure acute 2/433 (0.5%) 2 1/447 (0.2%) 1
    Urinary retention 0/433 (0%) 0 2/447 (0.4%) 2
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema 1/433 (0.2%) 1 0/447 (0%) 0
    Acute respiratory failure 1/433 (0.2%) 1 0/447 (0%) 0
    Bronchial secretion retention 1/433 (0.2%) 1 0/447 (0%) 0
    Chronic obstructive pulmonary disease 1/433 (0.2%) 1 1/447 (0.2%) 1
    Dyspnoea 15/433 (3.5%) 16 15/447 (3.4%) 15
    Dyspnoea exertional 1/433 (0.2%) 1 0/447 (0%) 0
    Emphysema 0/433 (0%) 0 1/447 (0.2%) 1
    Epistaxis 1/433 (0.2%) 1 0/447 (0%) 0
    Haemoptysis 3/433 (0.7%) 3 3/447 (0.7%) 3
    Hydropneumothorax 1/433 (0.2%) 1 0/447 (0%) 0
    Hydrothorax 1/433 (0.2%) 1 0/447 (0%) 0
    Hyperventilation 0/433 (0%) 0 1/447 (0.2%) 1
    Hypoxia 1/433 (0.2%) 1 3/447 (0.7%) 3
    Lung disorder 1/433 (0.2%) 1 0/447 (0%) 0
    Obstructive airways disorder 1/433 (0.2%) 1 0/447 (0%) 0
    Pleural effusion 1/433 (0.2%) 1 1/447 (0.2%) 1
    Pleurisy 0/433 (0%) 0 1/447 (0.2%) 1
    Pneumonitis 1/433 (0.2%) 1 1/447 (0.2%) 1
    Pulmonary embolism 2/433 (0.5%) 2 3/447 (0.7%) 3
    Pulmonary oedema 0/433 (0%) 0 2/447 (0.4%) 3
    Respiratory arrest 1/433 (0.2%) 1 1/447 (0.2%) 1
    Respiratory distress 1/433 (0.2%) 1 1/447 (0.2%) 1
    Respiratory failure 4/433 (0.9%) 4 0/447 (0%) 0
    Surgical and medical procedures
    Cardiac pacemaker battery replacement 0/433 (0%) 0 1/447 (0.2%) 1
    Vascular disorders
    Hypotension 0/433 (0%) 0 1/447 (0.2%) 1
    Pelvic venous thrombosis 0/433 (0%) 0 1/447 (0.2%) 1
    Shock haemorrhagic 0/433 (0%) 0 1/447 (0.2%) 1
    Superior vena caval occlusion 4/433 (0.9%) 4 2/447 (0.4%) 2
    Thrombophlebitis superficial 1/433 (0.2%) 1 0/447 (0%) 0
    Thrombosis 1/433 (0.2%) 1 0/447 (0%) 0
    Vascular insufficiency 1/433 (0.2%) 1 0/447 (0%) 0
    Other (Not Including Serious) Adverse Events
    Pemetrexed + Carboplatin Etoposide + Carboplatin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 425/ (NaN) 438/ (NaN)
    Blood and lymphatic system disorders
    Anaemia 135/433 (31.2%) 175 155/447 (34.7%) 200
    Leukopenia 33/433 (7.6%) 67 86/447 (19.2%) 179
    Neutropenia 82/433 (18.9%) 141 252/447 (56.4%) 524
    Thrombocytopenia 61/433 (14.1%) 117 94/447 (21%) 151
    Cardiac disorders
    Coronary artery disease 23/433 (5.3%) 23 24/447 (5.4%) 24
    Endocrine disorders
    Hypothyroidism 26/433 (6%) 26 12/447 (2.7%) 12
    Gastrointestinal disorders
    Abdominal pain 24/433 (5.5%) 26 27/447 (6%) 27
    Constipation 135/433 (31.2%) 165 124/447 (27.7%) 155
    Diarrhoea 62/433 (14.3%) 72 59/447 (13.2%) 69
    Dyspepsia 24/433 (5.5%) 24 24/447 (5.4%) 26
    Gastrooesophageal reflux disease 28/433 (6.5%) 28 21/447 (4.7%) 21
    Nausea 166/433 (38.3%) 261 159/447 (35.6%) 267
    Stomatitis 22/433 (5.1%) 23 15/447 (3.4%) 19
    Vomiting 71/433 (16.4%) 96 72/447 (16.1%) 106
    General disorders
    Asthenia 48/433 (11.1%) 55 43/447 (9.6%) 51
    Chest pain 98/433 (22.6%) 104 114/447 (25.5%) 127
    Fatigue 153/433 (35.3%) 177 182/447 (40.7%) 221
    Mucosal inflammation 22/433 (5.1%) 26 26/447 (5.8%) 33
    Oedema peripheral 38/433 (8.8%) 40 33/447 (7.4%) 41
    Pyrexia 26/433 (6%) 29 49/447 (11%) 59
    Investigations
    Haemoglobin decreased 22/433 (5.1%) 24 15/447 (3.4%) 15
    Weight decreased 60/433 (13.9%) 64 50/447 (11.2%) 53
    Metabolism and nutrition disorders
    Anorexia 108/433 (24.9%) 130 98/447 (21.9%) 120
    Diabetes mellitus 45/433 (10.4%) 45 44/447 (9.8%) 44
    Hypercholesterolaemia 45/433 (10.4%) 45 47/447 (10.5%) 47
    Hyperglycaemia 23/433 (5.3%) 25 18/447 (4%) 26
    Hypokalaemia 23/433 (5.3%) 24 17/447 (3.8%) 18
    Hyponatraemia 25/433 (5.8%) 31 27/447 (6%) 37
    Musculoskeletal and connective tissue disorders
    Arthralgia 23/433 (5.3%) 24 38/447 (8.5%) 43
    Back pain 61/433 (14.1%) 67 81/447 (18.1%) 91
    Bone pain 15/433 (3.5%) 16 26/447 (5.8%) 26
    Musculoskeletal pain 23/433 (5.3%) 23 31/447 (6.9%) 33
    Pain in extremity 29/433 (6.7%) 30 17/447 (3.8%) 18
    Nervous system disorders
    Dizziness 30/433 (6.9%) 34 41/447 (9.2%) 43
    Headache 49/433 (11.3%) 62 61/447 (13.6%) 78
    Psychiatric disorders
    Anxiety 45/433 (10.4%) 45 36/447 (8.1%) 36
    Depression 41/433 (9.5%) 41 38/447 (8.5%) 38
    Insomnia 72/433 (16.6%) 78 68/447 (15.2%) 78
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 69/433 (15.9%) 69 71/447 (15.9%) 71
    Cough 210/433 (48.5%) 218 221/447 (49.4%) 239
    Dysphonia 49/433 (11.3%) 50 42/447 (9.4%) 43
    Dyspnoea 178/433 (41.1%) 189 182/447 (40.7%) 200
    Haemoptysis 33/433 (7.6%) 34 32/447 (7.2%) 34
    Productive cough 31/433 (7.2%) 31 20/447 (4.5%) 21
    Skin and subcutaneous tissue disorders
    Alopecia 27/433 (6.2%) 29 156/447 (34.9%) 158
    Rash 23/433 (5.3%) 24 25/447 (5.6%) 36
    Vascular disorders
    Hypertension 180/433 (41.6%) 181 172/447 (38.5%) 175

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00363415
    Other Study ID Numbers:
    • 9691
    • H3E-MC-JMHO
    First Posted:
    Aug 15, 2006
    Last Update Posted:
    Oct 28, 2009
    Last Verified:
    Oct 1, 2009