BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer
NCT01263782 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2019-05-15
Summary
The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC.
Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.
Conditions
Interventions
- DRUG
-
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
- DRUG
-
Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
- DRUG
-
15 mg/kg by vein on day 1 of each 21 day cycle.
- DRUG
-
Cixutumumab
20 mg/kg by vein on day 1 of each 21 day cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Genentech, Inc.
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
George Simon, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-17
- Primary Completion
- 2017-08-15
- Completion
- 2017-08-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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