A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 2, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Genentech, Inc.
- Interventions being studied
- Drug: Placebo; Drug: cisplatin/carboplatin; Drug: onartuzumab; Drug: paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Study locationHuntsville, Alabama
- Study locationScottsdale, Arizona
- Study locationBakersfield, California
- Study locationFullerton, California
- Study locationLos Angeles, California
- Study locationLos Angeles, California
- Study locationNorthridge, California
- Study locationSacramento, California
- Study locationSan Luis Obispo, California
- Study locationSanta Barbara, California
- Study locationStanford, California
- Study locationGrand Junction, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 2, 2016. Always confirm current availability with the study team.