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

Genentech

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Placebo; Drug: paclitaxel; Drug: cisplatin/carboplatin; Drug: onartuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519804

GO27820

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

MetMAb+paclitaxel+platinum

Experimental group

Treatment:

Drug: onartuzumab

Drug: cisplatin/carboplatin

Drug: paclitaxel

Placebo+paclitaxel+platinum

Active Comparator group

Treatment:

Drug: cisplatin/carboplatin

Drug: Placebo

Drug: paclitaxel