Phase II Randomized Study of Maintenance Atezolizumab Versus Atezolizumab in Combination with Talazoparib in Patients with SLFN11 Positive Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Categories (click each to see list of all clinical trials associated with that category): Lung/Thoracic
Current Status: Open to accrual
Phase: II
Principal Investigator: Marr, Alissa
Contact Information:
Kimberly Shields
kimberly.shields@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04334941?term=NCT04334941&draw=2&rank=1#eligibility
Summary
PRIMARY OBJECTIVE:
I. To compare progression free survival (PFS) among participants with Schlafen family member 11 (SLFN11) positive extensive stage small cell lung cancer (ES-SCLC) randomized to atezolizumab or atezolizumab plus talazoparib as maintenance therapy.
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) between the arms. II. To compare objective response rate (ORR) among participants with measurable disease between the arms, including complete response (CR) and partial response (PR) (confirmed and unconfirmed) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
III. To evaluate the frequency and severity of adverse events within each treatment arm.
TRANSLATIONAL MEDICINE OBJECTIVE:
I. To bank specimens for future correlative studies.