A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation
A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)
Sponsor: Astellas Pharma Global Development, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR)
Time frame: Up to 2.3 years
Overall Survival (OS)
Time frame: Up to 4.2 years
Secondary Endpoints
Time to deterioration in NSCLC symptoms (TDLCS): cough evaluated via European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) items
TDLCS: chest pain evaluated via EORTC QLQ-LC13
TDLCS: dyspnea evaluated via EORTC QLQ-LC13
Eligibility Criteria
Inclusion Criteria: * Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status, based on local or central testing. * The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization. * If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the participant is enrolling via central testing, the eligibility sample must be from tissue. * Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to platinum combinations with pemetrexed, paclitaxel, etoposide or gemcitabine) in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) seq…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →