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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
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

RecruitingPhase 3

Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Conditions: Locally Advanced or Metastatic NSCLC

Interventions: ASKC202+ Limertinib, Pemetrexed + Cisplatin /Carboplatin

Countries: China

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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;
Locations (1)
  • Shanghai, China