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A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

Sponsor
Genentech, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01519804
Collaborator
(none)
108
Enrollment
69
Locations
2
Arms
41
Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: MetMAb+paclitaxel+platinum

Drug: cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles

Drug: onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
Other Names:
  • MetMAb

    • Drug: paclitaxel
    200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
    Active Comparator: Placebo+paclitaxel+platinum

    Drug: Placebo
    Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle

    Drug: cisplatin/carboplatin
    standard dose iv, Day 1 of each 21-day cycle, 4 cycles

    Drug: paclitaxel
    200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival (tumor assessments according to RECIST criteria) [up to approximately 32 months]

    2. Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC [up to approximately 32 months]

    Secondary Outcome Measures

    1. Overall survival [up to approximately 32 months]

    2. Overall response rate (tumor assessments according to RECIST criteria) [up to approximately 32 months]

    3. Duration of response (time from first documented objective response to disease progression) [up to approximately 32 months]

    4. Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [up to approximately 32 months]

    5. Safety: Incidence of adverse events [up to approximately 32 months]

    6. Pharmacokinetics: serum concentration (Cmin/Cmax) [Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years]

    7. Plasma concentrations of paclitaxel/platinum [Pre- and post-dose on Day 1 of Cycles 1 and 4]

    8. Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [Pre-dose Day 1 of Cycles 1, 2 and 4]

    Eligibility Criteria

    Criteria

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

    • Adult patients, >/= 18 years of age

    • Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)

    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

    • No prior chemotherapy for squamous NSCLC

    • Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown

    • Radiographic evidence of disease

    Exclusion Criteria:

    • Prior systemic treatment for Stage IIIB or IV squamous NSCLC

    • NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)

    • Prior exposure to experimental treatment targeting either the HGF or Met pathway

    • Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator

    • Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1

    • History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer

    • Pregnant or lactating women

    • Uncontrolled diabetes

    • Impaired bone marrow, liver or renal function as defined by protocol

    • Significant history of cardiovascular disease

    • Positive for HIV infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Huntsville Alabama United States 35805
    2 Scottsdale Arizona United States 85259
    3 Bakersfield California United States 93309
    4 Fullerton California United States 92835
    5 Los Angeles California United States 90024
    6 Los Angeles California United States 90095-1772
    7 Northridge California United States 91328
    8 Sacramento California United States 95817
    9 San Luis Obispo California United States 93454
    10 Santa Barbara California United States 93105
    11 Stanford California United States 94305
    12 Grand Junction Colorado United States 81502-1628
    13 Boynton Beach Florida United States 33435
    14 Orlando Florida United States 32804
    15 Weston Florida United States 33331
    16 Marietta Georgia United States 30060
    17 Chicago Illinois United States 60611
    18 Harvey Illinois United States 60426
    19 Fort Wayne Indiana United States 46815
    20 Fort Wayne Indiana United States 46845
    21 Indianapolis Indiana United States 46260
    22 Muncie Indiana United States 47303
    23 Metairie Louisiana United States 70006
    24 Boston Massachusetts United States 02114
    25 Boston Massachusetts United States 02215
    26 Minneapolis Minnesota United States 55454
    27 St. Louis Missouri United States 63110
    28 Las Vegas Nevada United States 89148
    29 Hickory North Carolina United States 28602
    30 Cleveland Ohio United States 44195
    31 Middletown Ohio United States 45042
    32 Bend Oregon United States 97701
    33 Pittsburgh Pennsylvania United States 15232
    34 Seattle Washington United States 98195
    35 Buenos Aires Argentina C1426ANZ
    36 La Rioja Argentina F5300COE
    37 Santa Rosa Argentina L6304BOC
    38 Grenoble France 38043
    39 Lyon France 69373
    40 Paris France 75674
    41 Rennes France 35033
    42 Berlin Germany 12203
    43 Göttingen Germany 37075
    44 Halle (Saale) Germany 06120
    45 Immenhausen Germany 34376
    46 München Germany 81925
    47 Münster Germany 48149
    48 Afula Israel 18101
    49 Ashkelon Israel 78278
    50 Tel Aviv Israel 6423906
    51 Zerifin Israel 6093000
    52 Avellino Campania Italy 83100
    53 Napoli Campania Italy 80131
    54 Udine Friuli-Venezia Giulia Italy 33100
    55 Cremona Lombardia Italy 26100
    56 Milano Lombardia Italy 20133
    57 Daugavpils Latvia 5417
    58 Liepaja Latvia LV 3401
    59 Riga Latvia LV 1079
    60 Riga Latvia LV-1002
    61 Pamplona Navarra Spain 31008
    62 Barcelona Spain 08036
    63 Madrid Spain 28007
    64 Madrid Spain 28050
    65 Zaragoza Spain 50009
    66 Aberdeen United Kingdom AB25 2ZN
    67 Birmingham United Kingdom B9 5SS
    68 Bournemouth United Kingdom BH7 7DW
    69 Leeds United Kingdom LS9 7TF

    Sponsors and Collaborators

    • Genentech, Inc.

    Investigators

    • Study Director: Clinical Trials, Genentech, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genentech, Inc.
    ClinicalTrials.gov Identifier:
    NCT01519804
    Other Study ID Numbers:
    • GO27820
    First Posted:
    Jan 27, 2012
    Last Update Posted:
    Sep 2, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin

    Study Results

    No Results Posted as of Sep 2, 2016