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

NCT ID: NCT07109531

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-12-31

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.

Detailed Description

This is a randomized, controlled, open-label, multicenter, phase 3 clinical study to valuate the efficacy and safety of ASKC202 combined with Limertinib in locally advanced or metastatic NSCLC with MET amplification/overexpression after failure of EGFR inhibitor therapy. Participants will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Conditions

Locally Advanced or Metastatic NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASKC202 + Limertinib

ASKC202+Limertinib

Group Type: EXPERIMENTAL

ASKC202+ Limertinib

Intervention Type: 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.

Pemetrexed + Cisplatin /Carboplatin

Pemetrexed+Cisplatin/Carboplatin

Group Type: ACTIVE_COMPARATOR

Pemetrexed + Cisplatin /Carboplatin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, , China

Countries

China

Central Contacts

Jiangsu Aosaikang Study Director

Role: CONTACT

ctr-contact@ask-pharm.com

+86 025 52169999

Facility Contacts

Caicun zhou, PHD

Role: primary

caicunzhoudr@163.com

+86-21-65115006

Other Identifiers

ASKC202-301

Identifier Type: -

Identifier Source: org_study_id