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

Not Recruiting

Trial ID: NCT01519804

Purpose

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.

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)

Stanford Investigator(s)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Eligibility


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

Intervention(s):

drug: onartuzumab

drug: Placebo

drug: paclitaxel

drug: cisplatin/carboplatin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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