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
- Conditions
- Stage III Non-Small Cell Lung CancerMedDRA version: 19.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001659-32-GR
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 186
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 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93
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
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether the addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based chemoradiotherapy with Paclitaxel/Carboplatin consolidation will improve progression-free survival (PFS) in patients with Stage III non-small cell lung cancer ;Secondary Objective: To assess overall survival (OS), objective response rate (ORR), duration of overall response (DOR), safety and tolerability of veliparib versus placebo added to standard therapy <br>;Primary end point(s): Progression-free survival;Timepoint(s) of evaluation of this end point: Tumor Assessments conducted at baseline, prior to consolidation chemotherapy, at 24 weeks after start of treatment, every 8 weeks until one year after beginning therapy, then every 12 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival, Duration of Response, Objective response rate;Timepoint(s) of evaluation of this end point: Survival assessment conducted every 8 weeks following progression