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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cisplatin; Paclitaxel

Criteria

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