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NCT06300177Recruiting

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.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Non Small Cell Lung Cancer
Drug/Device/Intervention
D-1553 Tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Location
Hefei,Beijing,Beijing,Beijing,Beijing,Beijing,Beijing,Chongqing,Chongqing,Chongqing,Chongqing,Chongqing,Fuzhou,Fuzhou,Fuzhou,Xiamen,Lanzhou,Lanzhou,Guangzhou,Guangzhou,Zhanjiang,Guilin,Nanning,Yulin,G, China
Timeline & enrollment
Phase
Phase 3
Start date
Mar 28, 2024
End date
Dec 01, 2027
Enrollment
522 participants
Primary outcome

Progression-free survival (PFS)

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.

ICD-10 classifications
Secondary malignant neoplasm of lungMalignant neoplasm: Lower lobe, bronchus or lungMalignant neoplasm: Middle lobe, bronchus or lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06300177
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06300177 through Pure Global AI's free database. This Phase 3 trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and is currently Recruiting. The study focuses on Non Small Cell Lung Cancer. Target enrollment is 522 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.