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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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: December 19, 2011
Last updated: September 1, 2016
Last verified: September 2016
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 Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Placebo
Drug: cisplatin/carboplatin
Drug: onartuzumab
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ]
  • Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC [ Time Frame: up to approximately 32 months ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to approximately 32 months ]
  • Overall response rate (tumor assessments according to RECIST criteria) [ Time Frame: up to approximately 32 months ]
  • Duration of response (time from first documented objective response to disease progression) [ Time Frame: up to approximately 32 months ]
  • Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks) [ Time Frame: up to approximately 32 months ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 32 months ]
  • Pharmacokinetics: serum concentration (Cmin/Cmax) [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years ]
  • Plasma concentrations of paclitaxel/platinum [ Time Frame: Pre- and post-dose on Day 1 of Cycles 1 and 4 ]
  • Serum levels of anti-therapeutic antibodies (MetMAb ATAs) [ Time Frame: Pre-dose Day 1 of Cycles 1, 2 and 4 ]

Enrollment: 108
Study Start Date: April 2012
Study Completion Date: September 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01519804

  Show 69 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT01519804     History of Changes
Other Study ID Numbers: GO27820
Study First Received: December 19, 2011
Last Updated: September 1, 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on May 24, 2017