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)

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Non-small Cell Lung Cancer Stage III

In brief

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.

Key facts

Study ID: NCT02412371
Run by: AbbVie
People needed: 48
Starts: 2015-04-30
Expected to finish: 2019-08-05
Last updated by the study team: 2020-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants with histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC).
Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
Participant must have adequate hematologic, renal, hepatic, and lung function.
Participant must consent to provide archived tissue or cytology sample of NSCLC lesion for analysis.

You may not qualify if…

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.
Participants with prior exposure to poly-adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors.
Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
Participants with prior mediastinal or thoracic radiotherapy. Prior tangential radiotherapy to prior breast cancer is acceptable.
Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).
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.
Participant is pregnant or lactating.
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.

Where it is running

Ucsd /Id# 133037 — La Jolla, California, United States
Christiana Care Health Service /ID# 133486 — Newark, Delaware, United States
University of Chicago /ID# 133828 — Chicago, Illinois, United States
Univ Maryland School Medicine /ID# 132944 — Baltimore, Maryland, United States
Dana-Farber Cancer Institute /ID# 133494 — Boston, Massachusetts, United States
SUNY Upstate Medical University - Downtown /ID# 133492 — Syracuse, New York, United States
Unc /Id# 133496 — Chapel Hill, North Carolina, United States
Duke University Medical Center /ID# 133497 — Durham, North Carolina, United States
Wake Forest Univ HS /ID# 134608 — Winston-Salem, North Carolina, United States
Rhode Island Hospital /ID# 133493 — Providence, Rhode Island, United States
The Miriam Hospital /ID# 133910 — Providence, Rhode Island, United States
University of Virginia /ID# 133495 — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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