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A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease


Inclusion Criteria:



- Adult patients, >/= 18 years of age

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

- Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor

- Met diagnostic-positive status tested by IHC

- Results of EGFR-activating mutation testing

- Radiographic evidence of disease

- Prior treatment with at least one platinum-based line of treatment (for stage
IIIb/IV) and no more than one additional line of chemotherapy treatment; the last
dose of chemotherapy must have been administered >/= 21 days prior to Day 1

- availability of tissue sample for diagnostic testing is required

Exclusion Criteria:

- More than 30 days of exposure to an investigational or marketed agent that can act by
EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications
(EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)

- Brain metastases or spinal cord compression not definitively treated with surgery
and/or radiation, or previously treated central nervous system (CNS) metastases or
spinal cord compression without evidence of stable disease for >/= 14 days

- History of another malignancy in the previous 3 years, unless cured by surgery alone
and continuously disease free for at least 3 years; patients with prior history of
non-invasive cancers are eligible

- Inadequate hematological, biochemical or organ function

- Significant history of cardiac disease

- Serious active infection at time of randomization or other serious underlying medical
conditions that would impair the ability of the patient to receive protocol treatment

- Any inflammatory changes of the surface of the eye

- Clinically significant gastro-intestinal disease, including uncontrolled inflammatory
gastro-intestinal diseases

- Pregnant or lactating women

- 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:

Overall survival

Outcome Time Frame:

time from randomization to death due to any cause, up to approximately 40 months

Safety Issue:

No

Principal Investigator

Holger Thurm, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

OAM4971g

NCT ID:

NCT01456325

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

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

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Omaha, Nebraska  68114
Albuquerque, New Mexico  87131-5636
Baltimore, Maryland  21287
Boston, Massachusetts  
Charleston, South Carolina  
Las Vegas, Nevada  89109