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)

Condition studied

KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC)

Investigational medicinal product(s)

Every trial of Setidegrasib across our registers →

Eligibility

Primary endpoint

Progression-Free Survival (PFS) perResponse Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR), Overall Survival (OS), defined as the time from the date of randomization until the date of death from any cause

Endpoint detail

TDLCS: evaluated via EORTC QLQ-LC13 items 31 (coughing), 33 to 35 (dyspnea) and 40 (chest pain), TWGQ, evaluated via EORTC QLQ-C30 items 29 and 30, Objective Response Rate (ORR) per RECIST v1.1, as assessed by BICR, Time to response (TTR), Duration of Response (DOR) and Disease Control Rate (DCR) per RECIST v1.1, as assessed by BICR; PFS, ORR, TTR, DOR and DCR per RECIST v1.1, Safety and tolerability evaluated via the following: AEs, SAEs, laboratory test results, ECGs, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status (PS) and assessment of harm, as measured by OS, End-of-Infusion (EOI) concentration and concentration immediately prior to dosing at multiple dosing (Ctrough), Change from baseline until week 12 in EORTC QLQ-C30, EORTC QLQ-LC13, EEQ-5D-5L VAS, PGIS and PGIC, PRO-CTCAE and FACT-GP responses over time