Veliparib With or Without Radiation Therapy, Carboplatin, and Paclitaxel in Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Study Summary

This phase I/II partially randomized trial studies the side effects and best dose of veliparib when given together with radiation therapy, carboplatin, and paclitaxel and to see how well it works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether radiation therapy, carboplatin, and paclitaxel are more effective with or without veliparib in treating non-small cell lung cancer.

Primary Outcome

DLTs will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. DLTs must be attributable (probably, possibly, definitely related) to the study regimen and only occur during RT or 2 weeks after completing RT. DLTs are defined as: 1. Radiation esophagitis or dermatitis radiation Grade 3 that lasts \> 7 consecutive days or Grade 4 2. Grade 4 neutropenia for \> 7 days or neutropenic fever ( ANC \<500 and temperature \>= 38.5 oC) 3. Grade 4 thrombocy

Conditions Studied

Interventions

• DRUG Carboplatin
• OTHER Laboratory Biomarker Analysis
• DRUG Paclitaxel
• RADIATION 3-Dimensional Conformal Radiation Therapy
• OTHER Placebo Administration

Study Locations (20)