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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

NCT06300177 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

D-1553 Tablet

D-1553 is a KRAS inhibitor.

DRUG

Docetaxel injection

Docetaxel, is an anti-tumor drug, significantly reduces the number of free tubules by promoting tubule polymerization into stable microtubules and inhibiting their depolymerization.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2026-10-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06300177 on ClinicalTrials.gov