A RANDOMIZED, PHASE III, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Not open
Phase: III
Principal Investigator: Muir, Kate-Lynn
Contact Information:
Trevor Beard
tbeard@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07144280?term=NCT07144280&limit=10&sort=@relevance&rank=1
Summary
PRIMARY OBJECTIVES
I. To compare the overall survival (OS) between the experimental arm (PF-08046054) and control arm (docetaxel) in participants with tumor PD-L1;1% (all participants) and participants with tumor PD-L1;50%
II. To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between the experimental and control arms in participants with tumor PD-L1;1% (all participants) and participants with tumor PD-L1;50%
SECONDARY OBJECTIVES
I. To compare progression-free survival (PFS) as assessed by blinded independent central review (BICR) between the experimental and control arms in participants with tumor PD-L1;1% (all participants) and participants with tumor PD-L1;50%
II. To compare PFS as assessed by investigator between the experimental and control arms
III. To compare the ORR as assessed by investigator between the experimental and control armS
IV. To estimate the duration of response (DOR) as assessed by BICR for the experimental and control arms
V. To estimate the duration of response (DOR) as assessed by investigator for the experimental and control arms
VI. To characterize the safety and tolerability profile of PF-08046054
VII. To compare change in quality of life (QoL), functioning, and lung cancer symptom response between the experimental and control arms
VIII. To compare time to definitive deterioration (TTdD) in QoL, functioning, and lung cancer symptoms between the experimental and control arms
IX. To characterize the pharmacokinetics (PK) of PF-08046054
X. To characterize the immunogenicity of PF-08046054