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

Study results available
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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

Carboplatin

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

Bevacizumab

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

  • Eli Lilly and Company

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263782 on ClinicalTrials.gov