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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (tumor assessments according to RECIST criteria)

Outcome Time Frame:

up to approximately 32 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27820

NCT ID:

NCT01519804

Start Date:

April 2012

Completion Date:

June 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Seattle, Washington  98195
Metairie, Louisiana  70006
Denver, Colorado  
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Las Vegas, Nevada  89109