A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of 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 (NSCLC)

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 156 人开始时间: 2016年9月26日最近更新: 2019年12月10日

试验速览

暂无简介。

•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

•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).

发起方