A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
• RO5490258 — DRUG
  15 mg/kg iv, Day 1 of each 21-day cycle
• bevacizumab [Avastin] — DRUG
  15 mg/kg iv, Day 1 of each 21-day cycle
• cisplatin/carboplatin — DRUG
  standard dose iv, Day 1 of each 21-day cycle, 4 cycles
• paclitaxel — DRUG
  200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
• pemetrexed — DRUG
  500 mg/m2, Day 1 of each 21-day cycle

Study Details

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Key Dates

First listed

Dec 21, 2011

Start date

Apr 30, 2012

Status verified

Sep 2016

Primary completion

Nov 30, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

259 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab+MetMAb
• Active Comparator: Bevacizumab+Placebo
• Experimental: Pemetrexed+MetMAb
• Active Comparator: Pemetrexed+Placebo

Primary Outcome Measure

Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 23 months ]

Locations (32)

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