Phase 3 Study Comparing D-1553 Tablet and Docetaxel Injection for Advanced KRAS G12C Mutation Positive Non-Small Cell Lung Cancer After Previous Treatment Failure

What this Trial Is About

Researchers are evaluating the progression-free survival of D-1553 Tablet compared to Docetaxel Injection in patients with KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer NSCLC who have not responded to prior standard therapy. This phase III, randomized, controlled, double-blind study aims to assess progression-free survival as the primary endpoint, with other outcomes measured over up to three years. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will receive either the experimental D-1553 Tablet or the active comparator Docetaxel Injection, each administered in 21-day treatment cycles. D-1553 is a KRAS inhibitor, while Docetaxel is an anti-tumor drug that works by affecting microtubule dynamics. The study design includes a quadruple masking and random allocation to ensure unbiased results. During the study, participants will undergo evaluations of progression-free survival, overall survival, response rates, disease control, and patient-reported outcomes over a period of up to three years. Safety assessments include monitoring adverse events and laboratory tests from consent through 30 days after the last dose. Pharmacokinetic parameters such as time to maximum plasma concentration and half-life will be measured during specific cycles. The total participation duration depends on individual treatment response and follow-up.

D-1553 Tablet Versus Docetaxel Injection for KRAS G12C Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer After Prior Standard Therapy Failure