Know Cancer

or
forgot password

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy Of Carboplatin/Paclitaxel And Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced Or Recurrent Non-small Cell Lung Cancer


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

Thank you

Trial Information

A Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety and Efficacy Of Carboplatin/Paclitaxel And Carboplatin/Paclitaxel/Bevacizumab With and Without GDC-0941 in Patients With Previously Untreated Advanced Or Recurrent Non-small Cell Lung Cancer


Inclusion Criteria:



- Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or
non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)

- Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE)
block or freshly cut unstained tumor slides from archival tumor tissue or a newly
collected tumor sample

- ECOG performance status of 0 or 1

- Disease that is measurable per RECIST v1.1

Exclusion Criteria:

- NSCLC with documented EGFR mutation associated with response to EGFR inhibitors or
documented fusion gene involving ALK gene

- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,
radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) before Day
1 of Cycle 1 for the treatment of advanced (Stage IV) or recurrent NSCLC

- Known CNS disease except for treated brain metastases

- Type I diabetes

- Type II diabetes requiring chronic therapy with insulin

- Medical conditions that would contraindicate bevacizumab therapy in non-squamous
NSCLC

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 (PFS), defined as the time from randomization to disease progression as assessed by the investigator per RECIST v1.1

Outcome Time Frame:

up to approximately 26 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GO27912

NCT ID:

NCT01493843

Start Date:

January 2012

Completion Date:

March 2016

Related Keywords:

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

Name

Location

New Britain, Connecticut  06052
Albany, Georgia  31701
Birmingham, Alabama  35294
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Omaha, Nebraska  68114
Albuquerque, New Mexico  87131-5636
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Las Vegas, Nevada  89109