A Phase III Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Thoracic (ONC)
Current Status: Open
Phase: III
Principal Investigator: Sharma, Bhavina
Contact Information:
Michaela Savine
misavine@unmc.edu
Summary
PRIMARY OBJECTIVES
I. To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of objective response (OR) as measured by ORR based on blinded independent central review (BICR) assessment per RECIST v1.1.
II. To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan, lurbinectedin, or amrubicin) in terms of efficacy as measured by overall survival (OS).
SECONDARY OBJECTIVES
I. To assess the safety and tolerability of ABBV-706 versus standard of care comparator.
II. To evaluate the efficacy of ABBV-706 versus standard of care comparator as measured by progression free survival (PFS) and duration of response (DoR) by BICR.
III. To evaluate the impact of ABBV-706 on patient-reported physical functioning and quality of life outcomes as measured by EORTC-QLQ-C30.