OncoMatch/Clinical Trials/NCT06300177
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
Is NCT06300177 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including D-1553 Tablet and Docetaxel for non small cell lung cancer.
Treatment: D-1553 Tablet · Docetaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: KRAS g12c
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — first-line
Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy
Must have received: anti-PD-L1 therapy — first-line
Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy
Must have received: platinum-based chemotherapy — first-line
Disease progression or toxicity after previous treatment with first-line anti-PD-1 / PD-L1 and platinum-containing chemotherapy is not tolerated.Subjects who have clear medical reasons and can not tolerate anti-PD-1 / PD-L1 therapy or platinum-containing chemotherapy
Cannot have received: KRAS G12C inhibitor
Treatment with a KRAS G12C mutation inhibitor or docetaxel at any previous time
Cannot have received: taxane (docetaxel)
Treatment with a KRAS G12C mutation inhibitor or docetaxel at any previous time
Lab requirements
Blood counts
Good function of the major organs
Kidney function
Good function of the major organs
Liver function
Good function of the major organs
Cardiac function
No NYHA Heart Function Grade II and above congestive heart failure; no severe cardiac arrhythmias requiring medical treatment; no acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment; LVEF ≥ 50%; no prolonged QTcF; hypertension must be effectively controlled
Good function of the major organs; Cardiovascular system meets any condition: 1. New York Heart Association (NYHA) Heart Function Grade II and above congestive heart failure; 2. Severe cardiac arrhythmias requiring medical treatment; 3. Acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass surgery within 6 months prior to enrollment; 4. Left ventricular ejection fraction (LVEF) <50%; 5. QT interval (QTcF) at prolonged; 6. Hypertension that is not effectively controlled
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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