A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Adults With Stage III Non-Small Cell Lung Cancer (NSCLC)
This study seeks to establish * the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent paclitaxel/carboplatin-based chemoradiotherapy (CRT) and consolidation with paclitaxel/carboplatin-based chemotherapy (Phase 1 portion), and * 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 adults with Stage III non-small cell lung cancer (Phase 2 portion). A strategy decision was made not to proceed to Phase 2 portion of this study due to change in standard of care.
Checked against the public recordLast updated Jul 22, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- AbbVie
- Interventions being studied
- Drug: Paclitaxel; Drug: Placebo for Veliparib; Drug: Carboplatin; Drug: Veliparib; Radiation: Radiotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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. 6. Participant must consent to provide archived tissue or cytology sample of NSCLC lesion for analysis. 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-adenosine diphosphate (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 radiotherapy 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). 6. Participants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years. 7. Participant is pregnant or lactating. 8. Participant with sensory peripheral neuropathy of ≥ Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ucsd /Id# 133037La Jolla, California
- Christiana Care Health Service /ID# 133486Newark, Delaware
- University of Chicago /ID# 133828Chicago, Illinois
- Univ Maryland School Medicine /ID# 132944Baltimore, Maryland
- Dana-Farber Cancer Institute /ID# 133494Boston, Massachusetts
- SUNY Upstate Medical University - Downtown /ID# 133492Syracuse, New York
- Unc /Id# 133496Chapel Hill, North Carolina
- Duke University Medical Center /ID# 133497Durham, North Carolina
- Wake Forest Univ HS /ID# 134608Winston-Salem, North Carolina
- Rhode Island Hospital /ID# 133493Providence, Rhode Island
- The Miriam Hospital /ID# 133910Providence, Rhode Island
- University of Virginia /ID# 133495Charlottesville, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2020. Always confirm current availability with the study team.