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Completed

NCT Number: NCT01496742

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

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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
  • Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and epidermal growth factor receptor (EGFR) testing if EGFR status is unknown
  • Radiographic evidence of disease

Exclusion criteria

  • Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
  • Evidence of mixed NSCLC with a predominance of the squamous cell type
  • Prior exposure to experimental treatment targeting either the hepatocyte growth factor (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, unless that treatment is unavailable or refused by the patient
  • Known central nervous system (CNS) disease, other than stable, treated brain metastases
  • History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
  • Uncontrolled diabetes
  • Pregnant or lactating women
  • Impaired bone marrow, liver or renal function (as defined by protocol)
  • Significant history of cardiovascular disease
  • Positive for HIV infection

Treatment and study plan

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

Other names: MetMAb

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

Primary outcomes

  1. Progression-free survival (tumor assessments according to RECIST criteria)

    Time frame: up to approximately 23 months

  2. Progression-free survival: Subgroup of patients with Met diagnostic positive tumors

    Time frame: up to approximately 23 months

Secondary outcomes

  1. Overall survival

    Time frame: up to approximately 23 months

  2. Overall response rate (tumor assessments according to RECIST criteria)

    Time frame: up to approximately 23 months

  3. Duration of response (time from first documented objective response to disease progression)

    Time frame: up to approximately 23 months

  4. Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)

    Time frame: up to approximately 23 months

  5. Safety: Incidence of adverse events

    Time frame: up to approximately 23 months

  6. Pharmacokinetics: serum concentration (Cmin/Cmax)

    Time frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and at study termination

  7. Serum concentrations of bevacizumab/paclitaxel/pemetrexed/platinum in combination with MetMAb

    Time frame: Pre- and post-dose on Day 1 of Cycles 1 and 4

  8. Serum levels of anti-therapeutic antibodies (MetMAb ATAs)

    Time frame: Pre-dose Day 1 of Cycles 1, 2 and 4

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2011
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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