BENITIONSClinical Trial Intelligence

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

Phase 1/2 Active, not recruiting NCT01386385

ConditionLung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma
PhasePhase 1/2
SponsorNational Cancer Institute (NCI)
StatusActive, not recruiting
Enrollment53 participants
Interventions3-Dimensional Conformal Radiation Therapy, Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Placebo Administration
Start dateJun 20, 2011
Completion dateMay 26, 2019
Results postedJul 12, 2021

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.

Maximum Tolerated Dose of Veliparib When Given Concurrently With Standard Carboplatin/Paclitaxel and Radiotherapy, Determined According to Incidence of Dose Limiting Toxicity (DLT) (Phase I)

9 weeks · dose limiting toxicity

Phase I 40mg Veliparib1 dose limiting toxicity
Phase I 80mg Veliparib1 dose limiting toxicity
Phase I 120mg Veliparib0 dose limiting toxicity

Progression-free Survival of Patients Treated With Chemoradiotherapy Plus Veliparib (Phase II)

The time from randomization to progression or death due to any cause, assessed up to 5 years · months

Arm I (RT, Veliparib, Carboplatin, Paclitaxel)9.3 months
Arm II (3D-CRT, Placebo, Carboplatin, Paclitaxel)9.9 months

Open in BENITIONS View on ClinicalTrials.gov

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