A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination with Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects with Stage III Non-Small Cell Lung Cancer

Phase 1

• Conditions: Stage III Non-Small Cell Lung Cancer; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 19.0 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2016-001659-32-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 156

Inclusion Criteria

1. Participants with Histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC).
2. Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
3. Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 – 1.
5. Participant must have adequate hematologic, renal, hepatic, and lung function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

1. Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC. Participants curatively treated for past early stage NSCLC greater than 3 years ago may be included.
2. Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors.
3. Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
4. Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable.
5. Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified