MedTrace Logo

Biomarker-Integrated Approach of Targeted Therapy for Lung Cancer Elimination Plus External Beam Radiation Therapy (BATTLE-XRT)

NCT02044601 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2014-04-24

No results posted yet for this study

Summary

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of onartuzumab that can be given with erlotinib and standard chemoradiation (paclitaxel and carboplatin) to patients with NSCLC.

The goal of Phase II is to learn if onartuzumab plus erlotinib and chemoradiation can help to control NSCLC. The safety of this drug will also be studied.

Conditions

Interventions

DRUG

Onartuzumab

Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle. Phase II: Maximum tolerated dose from Phase I.

DRUG

Erlotinib

Phase I and II: 150 mg by mouth every day throughout radiation, except for chemotherapy day.

DRUG

Paclitaxel

Phase I and II: 45 mg/m2 by vein once a week throughout radiation for 7 weeks.

DRUG

Carboplatin

Phase I and II: AUC 2 by vein once a week throughout radiation for 7 weeks.

RADIATION

Radiation Therapy

Phase I and II: Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • James Welsh, 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
2014-06-30
Primary Completion
2019-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02044601 on ClinicalTrials.gov