CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 53 enrolled / 53 target
Drug / intervention
Carboplatin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01386385
NCT01386385Phase 1ActiveUpdate Overdue (0.3/mo)Completion was 85mo ago
CompareCT.gov

A Dose Finding Study Followed by Phase II Randomized, Placebo-Controlled Study of Veliparib (ABT-888) Added to Chemoradiotherapy With Carboplatin and Paclitaxel for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC), (NCI Study Number 8811)

National Cancer Institute (NCI)·interventional·Posted Jul 1, 2011·Updated Jun 17, 2026

In Brief

A Phase 1 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Carboplatin, and 4 other interventions for Lung Adenocarcinoma and 7 related conditions. Active but no longer recruiting, targeting 53 participants across 233 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Adenocarcinoma, Lung Adenocarcinoma, Mixed Subtype, Lung Large Cell Carcinoma, Lung Squamous Cell Carcinoma, Minimally Invasive Lung Adenocarcinoma, Stage III Lung Non-Small Cell Cancer AJCC v7, Stage IIIA Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7
CountriesUnited States
Collaborators--

Timeline

Phase 1Active
2012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2011
Enrollment StartJun 20, 2011
Primary CompletionMay 26, 2019
Study CompletionDec 31, 2026
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 15.0 years ago

Arms & Interventions

Arm I (RT, veliparib, carboplatin, paclitaxel)experimental

Patients undergo 3D-CRT and receive veliparib, carboplatin, and paclitaxel as in Phase I induction and consolidation therapy.

Radiation: 3-Dimensional Conformal Radiation TherapyDrug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelDrug: Veliparib
Arm II (3D-CRT, placebo, carboplatin, paclitaxel)active_comparator

Patients undergo 3D-CRT as in arm I. Patients also receive placebo PO BID on days 1-43 and carboplatin and paclitaxel as in Phase I. Within 4-6 weeks after completion of chemotherapy and radiation therapy, patients receive placebo on days 1-7 and carboplatin and paclitaxel as in Phase I.

Radiation: 3-Dimensional Conformal Radiation TherapyDrug: CarboplatinOther: Laboratory Biomarker AnalysisDrug: PaclitaxelOther: Placebo Administration

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo 3D-conformal RT

Carboplatindrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Placebo Administrationother

Given PO

Veliparibdrug

Given PO