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

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01493843 (View complete trial on
DFCI Protocol ID: 12-293


This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial with four arms that will be conducted at approximately 75 to 100 sites in countries of the European Union (EU), the United States (US), and other select countries.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Bruce Johnson, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Mark Huberman, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - 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 - Histologically documented advanced (Stage IV) or recurrent squamous NSCLC Exclusion Criteria: - 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
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