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A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous 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 Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous
non-small cell lung cancer (NSCLC)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- For patients who received prior adjuvant chemotherapy: a treatment-free interval of
at least 12 months since last chemotherapy cycle

- 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 non-squamous NSCLC

- Evidence of mixed NSCLC with a predominance of the squamous cell type

- 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

- Known central nervous system (CNS) disease, other than stable, treated brain
metastases

- History of another malignancy in the previous 3 years, except for history of in situ
cancer or basal or squamous cell skin cancer

- Uncontrolled diabetes

- Pregnant or lactating women

- 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 23 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27821

NCT ID:

NCT01496742

Start Date:

April 2012

Completion Date:

December 2013

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
Albany, New York  12208
Cleveland, Ohio  44195
Seattle, Washington  98195
Metairie, Louisiana  70006
Denver, Colorado  
Charlotte, North Carolina  
Eugene, Oregon  
Indianapolis, Indiana  
Las Vegas, Nevada  89109