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Clinical Trials in China / NCT07109531
Recruiting Phase 3

ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy

NCT07109531 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2025-08-04
Last updated
2026-08-19

Condition(s) studied

Locally Advanced or Metastatic NSCLC

Investigational drug(s) / intervention(s)

ASKC202+ LimertinibPemetrexed + Cisplatin /Carboplatin

ASKC202+ Limertinib: ASKC202 orally once per day (QD) combined with Limertinib orally BID for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met.

Pemetrexed + Cisplatin /Carboplatin: The standard chemotherapy treatment of cisplatin/carboplatin combined with pemetrexed on Day 1of 21 day cycles for 4\~6 cycles (every 3 weeks).

Study summary

This study is designed to compare the safety and efficacy of ASKC202 combined with Limertinib Versus platinum-based chemotherapy in locally advanced or metastatic NSCLC With MET Amplification/Overexpression after disease progression on EGFR tyrosine kinase inhibitor.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Willing and able to provide signed and dated informed consent; 2. Patients at least 18 years of age; 3. Locally advanced or metastatic non-small cell lung cancer (NSCLC); 4. Objective disease progression following prior EGFR-TKI therapy; 5. EGFR mutation with MET amplification/Overexpression by a central laboratory; 6. Measurable lesions based on RECIST 1. 1; 7. ECOG performance status 0 or 1; 8. Expected survival \>12 weeks; 9. Adequate bone marrow reserve or organ function. Exclusion Criteria: 1. Prior or ongoing treatment with any c-Met target; 2. Previously received systemic chemotherapy; 3. Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose. 4. Patients who underwent other major surgical procedures other than diagnosis or biopsy within 4 weeks prior to the first dose, or who were expected to undergo major surgeries during the study period; 5. Prior to the first administration, there are unhealed toxic reactions of ≥ grade 2 (CTCAE 5.0 standard) associated with any previous treatment, any level of hair loss, and platinum drugs Except for grade 2 neuropathy caused; 6. Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression; 7. Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption; 8. Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD; 9. Have previously received hematopoietic stem cell transplants or solid organ transplants, or plan to receive hematopoietic stem cell transplants or solid organ transplants during the current period of study; 10. There are serious or active infections that required intravenous antibiotics or hospitalization, such as HBV (HBsAg-positive and peripheral HBV-DNA titer test≥1×104 copies/mL or 2000 IU/mL), HCV, HIV, and syphilis; 11. Serious or uncontrolled cardiovascular disease; 12. Pregnant or lactating females; 13. Other primary malignancies have been diagnosed within the last 5 years, and the following conditions can be enrolled: non-melanoma skin cancer, superficial bladder cancer, cervical carcinoma in situ that has undergone surgery and has been cured;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai East Hospital Shanghai China Recruiting

More Jiangsu Aosaikang Pharmaceutical Co., Ltd. trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07109531 on ClinicalTrials.gov ↗ ← All trials in China