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
A Randomized, Controlled, Double-blind, Double-simulated, Multicenter Phase III Clinical Study Evaluating 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.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
522 participants
Mar 28, 2024
INTERVENTIONAL
Conditions
Summary
The purpose of this project is to evaluate progression-free survival (PFS) of D-1553 Tablet versus Docetaxel Injection in subjects with prior standard therapy failure kirsten rat sarcoma viral oncogene (KRAS) G12C mutation positive locally advanced or metastatic non small cell lung cancer (NSCLC), progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) based on RECIST 1.1 was used as the primary endpoint.
Eligibility
Plain Language Summary
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Interventions
D-1553 is a KRAS inhibitor.
Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.
Locations(86)
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NCT06300177