A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01769391
Collaborator
(none)
167
51
2
53.9
3.3
0.1
Study Details
Study Description
Brief Summary
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
167 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Study Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Apr 1, 2015
Actual Study Completion Date
:
Jul 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Necitumumab +Paclitaxel+Carboplatin Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. |
Drug: Necitumumab
Administered IV
Other Names:
Drug: Paclitaxel
Administered IV
Drug: Carboplatin
Administered IV
|
| Active Comparator: Paclitaxel + Carboplatin Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD. |
Drug: Paclitaxel
Administered IV
Drug: Carboplatin
Administered IV
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) [Baseline to Disease Progression or Death (Up to 24 Months)]
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Secondary Outcome Measures
- Overall Survival (OS) [Randomization to Date of Death (Up to 24 Months)]
OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab [Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)]
- Percentage of Participants With Anti Necitumumab Antibodies [Baseline to End of Cycle 6]
- Progression-Free Survival [Randomization to Progressive Disease or Death (Up to 24 Months)]
Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
- Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) [Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)]
Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).
- Percent Change in Tumor Size (CTS) [Baseline to Progressive Disease or Death (Up to 24 Months)]
CTS is defined as maximum percent change from baseline in the sum of target lesions.
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically or cytologically confirmed squamous NSCLC
-
Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
-
Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
-
Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments
Exclusion Criteria:
-
Nonsquamous NSCLC
-
Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
-
Previous chemotherapy for NSCLC
-
Major surgery or received any investigational therapy in the 4 weeks prior to randomization
-
Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
-
Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
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. | Jonesboro | Arkansas | United States | 72401 |
| 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. | Los Angeles | California | United States | 90048 |
| 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. | Sacramento | California | United States | 95816 |
| 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. | Colorado Springs | Colorado | United States | 80907 |
| 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. | Fleming Island | Florida | United States | 32003 |
| 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. | Fort Myers | Florida | United States | 33916 |
| 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. | Miami Beach | Florida | United States | 33140 |
| 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. | Port Saint Lucie | Florida | United States | 34952 |
| 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. | Saint Petersburg | Florida | United States | 33705 |
| 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. | Macon | Georgia | United States | 31201 |
| 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. | Marietta | Georgia | United States | 30060 |
| 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. | Savannah | Georgia | United States | 31404 |
| 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. | Valdosta | Georgia | United States | 31602 |
| 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. | Wichita | Kansas | United States | 67214 |
| 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. | Louisville | Kentucky | United States | 40202 |
| 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. | Kalamazoo | Michigan | United States | 49007 |
| 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. | Lansing | Michigan | United States | 48910 |
| 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. | Woodbury | Minnesota | United States | 55125 |
| 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. | Billings | Montana | United States | 59101 |
| 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. | Lincoln | Nebraska | United States | 68510 |
| 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. | Cherry Hill | New Jersey | United States | 08003 |
| 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. | Hackensack | New Jersey | United States | 07601 |
| 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. | Latham | New York | United States | 12110 |
| 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. | Cincinnati | Ohio | United States | 45242 |
| 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. | Eugene | Oregon | United States | 97401 |
| 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. | Charleston | South Carolina | United States | 29425 |
| 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. | Columbia | South Carolina | United States | 29210 |
| 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. | Chattanooga | Tennessee | United States | 37404 |
| 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. | Memphis | Tennessee | United States | 38120 |
| 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. | Nashville | Tennessee | United States | 37203 |
| 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. | Fort Worth | Texas | United States | 76104 |
| 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. | The Woodlands | Texas | United States | 77380 |
| 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. | Richmond | Virginia | United States | 23230 |
| 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. | Großhansdorf | Germany | 22927 | |
| 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. | Heidelberg | Germany | 69126 | |
| 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. | Immenhausen | Germany | 34376 | |
| 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. | Münster | Germany | 48149 | |
| 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. | Incheon | Korea, Republic of | 405-760 | |
| 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. | Seoul | Korea, Republic of | 135-710 | |
| 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. | Ulsan-Si | Korea, Republic of | 682-714 | |
| 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. | Chihuahua | Mexico | 31000 | |
| 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. | Leon | Mexico | 37000 | |
| 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. | Mexico City | Mexico | 6700 | |
| 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. | Monterrey | Mexico | 64000 | |
| 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. | Glucholazy | Poland | 48-340 | |
| 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. | Olsztyn | Poland | 10-357 | |
| 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. | Otwock | Poland | 05-400 | |
| 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. | Poznan | Poland | 60-693 | |
| 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. | Radom | Poland | 26-617 | |
| 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. | Warsaw | Poland | 02-781 | |
| 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. | Saint Petersburg | Russian Federation | 194291 |
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
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769391
Other Study ID Numbers:
- 14790
- I4X-MC-JFCL
- 2012-003214-13
First Posted:
Jan 16, 2013
Last Update Posted:
Sep 20, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A completer is defined as having a complete radiographic assessment at baseline and at least one complete post-baseline radiographic assessment of CR, PR , SD or PD. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. |
| Period Title: Overall Study | ||
| STARTED | 110 | 57 |
| Received at Least One Dose of Study Drug | 106 | 55 |
| COMPLETED | 93 | 48 |
| NOT COMPLETED | 17 | 9 |
Baseline Characteristics
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin | Total |
|---|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. | Total of all reporting groups |
| Overall Participants | 110 | 57 | 167 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
65.5
(9.36)
|
64.7
(8.27)
|
65.3
(8.98)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
23
20.9%
|
13
22.8%
|
36
21.6%
|
| Male |
87
79.1%
|
44
77.2%
|
131
78.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
2.7%
|
4
7%
|
7
4.2%
|
| Not Hispanic or Latino |
105
95.5%
|
53
93%
|
158
94.6%
|
| Unknown or Not Reported |
2
1.8%
|
0
0%
|
2
1.2%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
2
3.5%
|
2
1.2%
|
| Asian |
10
9.1%
|
6
10.5%
|
16
9.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
2.7%
|
2
3.5%
|
5
3%
|
| White |
97
88.2%
|
47
82.5%
|
144
86.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| Russia |
28
25.5%
|
12
21.1%
|
40
24%
|
| United States |
53
48.2%
|
25
43.9%
|
78
46.7%
|
| Poland |
12
10.9%
|
7
12.3%
|
19
11.4%
|
| South Korea |
10
9.1%
|
6
10.5%
|
16
9.6%
|
| Mexico |
3
2.7%
|
3
5.3%
|
6
3.6%
|
| Germany |
4
3.6%
|
4
7%
|
8
4.8%
|
Outcome Measures
| Title | Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) |
|---|---|
| Description | The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. |
| Time Frame | Baseline to Disease Progression or Death (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. |
| Measure Participants | 94 | 50 |
| Number (95% Confidence Interval) [percentage of participants] |
48.9
44.5%
|
40.0
70.2%
|
| Title | Overall Survival (OS) |
|---|---|
| Description | OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status). |
| Time Frame | Randomization to Date of Death (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. |
| Measure Participants | 110 | 57 |
| Median (95% Confidence Interval) [months] |
13.2
|
11.2
|
| Title | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab |
|---|---|
| Description | |
| Time Frame | Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of necitumumab and had evaluable PK data. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin |
|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. |
| Measure Participants | 92 |
| Cycle 1, Day 1 (n=92) |
262.418
(32.84)
|
| Cycle 3, Day 1 (n=72) |
296.843
(62.97)
|
| Cycle 5, Day 1 (n=62) |
303.475
(53.75)
|
| Title | Percentage of Participants With Anti Necitumumab Antibodies |
|---|---|
| Description | |
| Time Frame | Baseline to End of Cycle 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received any amount of necitumumab and had post baseline antibody data. |
| Arm/Group Title | Necitumumab + Paclitaxel+ Carboplatin |
|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. |
| Measure Participants | 106 |
| Number [percentage of participants] |
2.8
2.5%
|
| Title | Progression-Free Survival |
|---|---|
| Description | Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment. |
| Time Frame | Randomization to Progressive Disease or Death (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. |
| Measure Participants | 110 | 57 |
| Median (95% Confidence Interval) [months] |
5.4
|
5.6
|
| Title | Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) |
|---|---|
| Description | Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions). |
| Time Frame | Baseline to Progressive Disease and/or Death (Estimated up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. |
| Measure Participants | 94 | 50 |
| Number (95% Confidence Interval) [percentage of participants] |
87.2
79.3%
|
84.0
147.4%
|
| Title | Percent Change in Tumor Size (CTS) |
|---|---|
| Description | CTS is defined as maximum percent change from baseline in the sum of target lesions. |
| Time Frame | Baseline to Progressive Disease or Death (Up to 24 Months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin |
|---|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. |
| Measure Participants | 83 | 43 |
| Mean (Standard Deviation) [percent change in tumor size] |
-44.3
(22.8)
|
-38.65
(24.4)
|
| Title | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab |
|---|---|
| Description | |
| Time Frame | Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin |
|---|---|
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. |
| Measure Participants | 92 |
| Cycle 1, Day 8 (n-85) |
59.269
(59.06)
|
| Cycle 2, Day 1 (n=79) |
47.874
(79.89)
|
| Cycle 3, Day 1 (n=76) |
78.142
(70.99)
|
| Cycle 4, Day 1 (n=70) |
80.392
(74.42)
|
| Cycle 5, Day 1 (n=62) |
89.137
(88.94)
|
| Cycle 6, Day 1 (n=59) |
87.043
(85.02)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least 1 dose of study drug. | |||
| Arm/Group Title | Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin | ||
| Arm/Group Description | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. | Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. | ||
All Cause Mortality |
||||
| Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 43/106 (40.6%) | 21/55 (38.2%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 5/106 (4.7%) | 5 | 4/55 (7.3%) | 4 |
| Anaemia of chronic disease | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Febrile neutropenia | 7/106 (6.6%) | 7 | 2/55 (3.6%) | 3 |
| Leukopenia | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Neutropenia | 5/106 (4.7%) | 5 | 2/55 (3.6%) | 2 |
| Thrombocytopenia | 2/106 (1.9%) | 3 | 1/55 (1.8%) | 1 |
| Cardiac disorders | ||||
| Atrial fibrillation | 4/106 (3.8%) | 4 | 4/55 (7.3%) | 4 |
| Cardiac arrest | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Cardiac failure congestive | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Myocardial infarction | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Constipation | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Diarrhoea | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Dysphagia | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Gastric ulcer haemorrhage | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Ileus | 1/106 (0.9%) | 2 | 0/55 (0%) | 0 |
| Small intestinal obstruction | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Stomatitis | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Vomiting | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| General disorders | ||||
| Asthenia | 5/106 (4.7%) | 10 | 0/55 (0%) | 0 |
| Brain death | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Death | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Mucosal inflammation | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Non-cardiac chest pain | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Oedema peripheral | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pain | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pyrexia | 2/106 (1.9%) | 2 | 1/55 (1.8%) | 1 |
| Sudden death | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Systemic inflammatory response syndrome | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Infections and infestations | ||||
| Bacterial sepsis | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Cellulitis | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Clostridium difficile colitis | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Diverticulitis | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Herpes simplex | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Herpes zoster | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Lung infection | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Perirectal abscess | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pneumonia | 14/106 (13.2%) | 15 | 4/55 (7.3%) | 4 |
| Pneumonia bacterial | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pneumonia viral | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Sepsis | 3/106 (2.8%) | 4 | 2/55 (3.6%) | 2 |
| Septic shock | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 1 |
| Urinary tract infection | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Fall | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Thermal burn | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Investigations | ||||
| Neutrophil count decreased | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 3/106 (2.8%) | 3 | 1/55 (1.8%) | 2 |
| Hypocalcaemia | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Hypomagnesaemia | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Muscular weakness | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant neoplasm progression | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Malignant pleural effusion | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral ischaemia | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Depressed level of consciousness | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Encephalopathy | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Loss of consciousness | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Neuropathy peripheral | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Syncope | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 1 |
| Psychiatric disorders | ||||
| Delirium | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Mental status changes | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 2/106 (1.9%) | 2 | 1/55 (1.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Bronchial obstruction | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Chronic obstructive pulmonary disease | 3/106 (2.8%) | 3 | 1/55 (1.8%) | 1 |
| Cough | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Dyspnoea | 5/106 (4.7%) | 5 | 1/55 (1.8%) | 1 |
| Epistaxis | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Haemoptysis | 2/106 (1.9%) | 2 | 0/55 (0%) | 0 |
| Hypoxia | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 1 |
| Interstitial lung disease | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pneumonitis | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 1 |
| Pneumothorax spontaneous | 0/106 (0%) | 0 | 1/55 (1.8%) | 1 |
| Pulmonary embolism | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Pulmonary haemorrhage | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 2 |
| Respiratory failure | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Vascular disorders | ||||
| Circulatory collapse | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Deep vein thrombosis | 1/106 (0.9%) | 1 | 1/55 (1.8%) | 1 |
| Haemorrhage | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Hypotension | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
| Hypovolaemic shock | 1/106 (0.9%) | 1 | 0/55 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Necitumumab +Paclitaxel+Carboplatin | Paclitaxel + Carboplatin | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 102/106 (96.2%) | 49/55 (89.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 34/106 (32.1%) | 87 | 27/55 (49.1%) | 62 |
| Leukopenia | 9/106 (8.5%) | 16 | 9/55 (16.4%) | 15 |
| Neutropenia | 37/106 (34.9%) | 73 | 16/55 (29.1%) | 43 |
| Thrombocytopenia | 27/106 (25.5%) | 67 | 14/55 (25.5%) | 31 |
| Eye disorders | ||||
| Vision blurred | 2/106 (1.9%) | 2 | 3/55 (5.5%) | 3 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 8/106 (7.5%) | 11 | 2/55 (3.6%) | 2 |
| Constipation | 25/106 (23.6%) | 28 | 15/55 (27.3%) | 23 |
| Diarrhoea | 26/106 (24.5%) | 34 | 12/55 (21.8%) | 18 |
| Dyspepsia | 6/106 (5.7%) | 6 | 3/55 (5.5%) | 3 |
| Nausea | 27/106 (25.5%) | 35 | 20/55 (36.4%) | 34 |
| Stomatitis | 14/106 (13.2%) | 15 | 3/55 (5.5%) | 3 |
| Vomiting | 13/106 (12.3%) | 17 | 8/55 (14.5%) | 11 |
| General disorders | ||||
| Asthenia | 18/106 (17%) | 31 | 3/55 (5.5%) | 5 |
| Fatigue | 33/106 (31.1%) | 52 | 24/55 (43.6%) | 48 |
| Non-cardiac chest pain | 7/106 (6.6%) | 8 | 1/55 (1.8%) | 1 |
| Oedema peripheral | 11/106 (10.4%) | 15 | 7/55 (12.7%) | 9 |
| Pain | 7/106 (6.6%) | 9 | 0/55 (0%) | 0 |
| Pyrexia | 10/106 (9.4%) | 16 | 4/55 (7.3%) | 5 |
| Infections and infestations | ||||
| Conjunctivitis | 7/106 (6.6%) | 9 | 0/55 (0%) | 0 |
| Paronychia | 6/106 (5.7%) | 9 | 0/55 (0%) | 0 |
| Pneumonia | 6/106 (5.7%) | 9 | 2/55 (3.6%) | 2 |
| Injury, poisoning and procedural complications | ||||
| Fall | 2/106 (1.9%) | 2 | 3/55 (5.5%) | 4 |
| Investigations | ||||
| Aspartate aminotransferase increased | 7/106 (6.6%) | 9 | 0/55 (0%) | 0 |
| Neutrophil count decreased | 8/106 (7.5%) | 18 | 6/55 (10.9%) | 7 |
| Weight decreased | 31/106 (29.2%) | 49 | 14/55 (25.5%) | 20 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 34/106 (32.1%) | 40 | 15/55 (27.3%) | 20 |
| Dehydration | 11/106 (10.4%) | 15 | 10/55 (18.2%) | 17 |
| Hypoalbuminaemia | 5/106 (4.7%) | 9 | 3/55 (5.5%) | 4 |
| Hypocalcaemia | 10/106 (9.4%) | 19 | 2/55 (3.6%) | 2 |
| Hypokalaemia | 14/106 (13.2%) | 28 | 4/55 (7.3%) | 7 |
| Hypomagnesaemia | 25/106 (23.6%) | 74 | 7/55 (12.7%) | 12 |
| Hyponatraemia | 7/106 (6.6%) | 13 | 1/55 (1.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 24/106 (22.6%) | 61 | 13/55 (23.6%) | 29 |
| Back pain | 10/106 (9.4%) | 11 | 3/55 (5.5%) | 3 |
| Bone pain | 8/106 (7.5%) | 10 | 8/55 (14.5%) | 14 |
| Muscular weakness | 10/106 (9.4%) | 10 | 4/55 (7.3%) | 7 |
| Musculoskeletal chest pain | 1/106 (0.9%) | 1 | 7/55 (12.7%) | 9 |
| Musculoskeletal pain | 3/106 (2.8%) | 5 | 4/55 (7.3%) | 7 |
| Myalgia | 18/106 (17%) | 44 | 12/55 (21.8%) | 21 |
| Pain in extremity | 8/106 (7.5%) | 10 | 8/55 (14.5%) | 8 |
| Nervous system disorders | ||||
| Dizziness | 14/106 (13.2%) | 16 | 8/55 (14.5%) | 10 |
| Dysgeusia | 8/106 (7.5%) | 10 | 4/55 (7.3%) | 4 |
| Headache | 4/106 (3.8%) | 6 | 7/55 (12.7%) | 7 |
| Neuropathy peripheral | 13/106 (12.3%) | 21 | 9/55 (16.4%) | 18 |
| Paraesthesia | 3/106 (2.8%) | 3 | 3/55 (5.5%) | 3 |
| Peripheral sensory neuropathy | 31/106 (29.2%) | 54 | 13/55 (23.6%) | 24 |
| Syncope | 8/106 (7.5%) | 8 | 1/55 (1.8%) | 1 |
| Psychiatric disorders | ||||
| Anxiety | 6/106 (5.7%) | 6 | 0/55 (0%) | 0 |
| Insomnia | 14/106 (13.2%) | 16 | 6/55 (10.9%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 18/106 (17%) | 24 | 10/55 (18.2%) | 10 |
| Dysphonia | 4/106 (3.8%) | 5 | 3/55 (5.5%) | 4 |
| Dyspnoea | 23/106 (21.7%) | 29 | 6/55 (10.9%) | 13 |
| Dyspnoea exertional | 0/106 (0%) | 0 | 3/55 (5.5%) | 4 |
| Epistaxis | 2/106 (1.9%) | 2 | 3/55 (5.5%) | 3 |
| Haemoptysis | 7/106 (6.6%) | 7 | 6/55 (10.9%) | 8 |
| Nasal congestion | 4/106 (3.8%) | 6 | 3/55 (5.5%) | 3 |
| Oropharyngeal pain | 3/106 (2.8%) | 3 | 3/55 (5.5%) | 3 |
| Productive cough | 1/106 (0.9%) | 1 | 3/55 (5.5%) | 4 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 28/106 (26.4%) | 30 | 10/55 (18.2%) | 11 |
| Dermatitis acneiform | 23/106 (21.7%) | 40 | 0/55 (0%) | 0 |
| Dry skin | 13/106 (12.3%) | 13 | 1/55 (1.8%) | 1 |
| Pruritus | 6/106 (5.7%) | 6 | 0/55 (0%) | 0 |
| Rash | 22/106 (20.8%) | 69 | 1/55 (1.8%) | 1 |
| Rash maculo-papular | 8/106 (7.5%) | 17 | 0/55 (0%) | 0 |
| Rash papular | 12/106 (11.3%) | 16 | 0/55 (0%) | 0 |
| Vascular disorders | ||||
| Hypotension | 12/106 (11.3%) | 13 | 7/55 (12.7%) | 10 |
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 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769391
Other Study ID Numbers:
- 14790
- I4X-MC-JFCL
- 2012-003214-13
First Posted:
Jan 16, 2013
Last Update Posted:
Sep 20, 2019
Last Verified:
Sep 1, 2019