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 | Not Yet Recruiting Phase 3

• 1 other identifier: ASKC202-301
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced or Metastatic NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) by BIRC

  Progression-free survival (PFS) using BIRC assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause in the absence of progression (whichever occurred first).

  2 years

Secondary Outcomes (6)

• Progression-free survival (PFS) by investigator

  2 years

• Overall Survival (OS)

  3 years

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of Response (DoR)

  2 years

Study Arms (2)

ASKC202 + Limertinib

EXPERIMENTAL

ASKC202+Limertinib

Drug: ASKC202+ Limertinib

Pemetrexed + Cisplatin /Carboplatin

ACTIVE COMPARATOR

Pemetrexed+Cisplatin/Carboplatin

Drug: Pemetrexed + Cisplatin /Carboplatin

Interventions

ASKC202+ Limertinib DRUG

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.

ASKC202 + Limertinib

Pemetrexed + Cisplatin /Carboplatin DRUG

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

Pemetrexed + Cisplatin /Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide signed and dated informed consent;
• Patients at least 18 years of age;
• Locally advanced or metastatic non-small cell lung cancer (NSCLC);
• Objective disease progression following prior EGFR-TKI therapy;
• EGFR mutation with MET amplification/Overexpression by a central laboratory;
• Measurable lesions based on RECIST 1. 1;
• ECOG performance status 0 or 1;
• Expected survival \>12 weeks;
• Adequate bone marrow reserve or organ function.

You may not qualify if:

• Prior or ongoing treatment with any c-Met target;
• Previously received systemic chemotherapy;
• Patients requiring continuous use of systemic immunosuppressants or systemic corticosteroids within 2 weeks prior to the first dose.
• 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;
• 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;
• Patients with leptomeningeal metastasis, brainstem metastasis, or spinal cord compression;
• Presence of dysphagia or gastrointestinal disorders that may interfere with oral medication absorption;
• Previous history includes interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy, or evidence of clinically active ILD；
• 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;
• 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;
• Serious or uncontrolled cardiovascular disease;
• Pregnant or lactating females;
• 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;

Sponsors & Collaborators

• Jiangsu Aosaikang Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

Jiangsu Aosaikang Study Director

CONTACT

+86 025 52169999; ctr-contact@ask-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, open-label, multicenter, phase 3 clinical study. The primary endpoint of this study is PFS as assessed by BIRC. patients with locally advanced or metastatic NSCLC with MET amplification/Overexpression after failure of EGFR inhibitor therapy are randomly assigned 1:1 stratified by MET amplification (MET GCN≥10 or MET GCN\<10 )and brain metastasis (YES or NO) and EGFR mutation type(L858R；Del19) to receive ASKC202+ Limertinib or platinum-based chemotherapy.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

CN (1)