Actively Recruiting
Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial
Led by Samsung Medical Center · Updated on 2026-02-23
47
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Lazertinib and Tepotinib for patients with EGFR mutated non-small cell lung cancer (NSCLC) who have MET overexpression or amplification and whose disease has progressed after treatment with Lazertinib. This phase II trial focuses on understanding treatment options for patients who develop resistance to first-line Lazertinib therapy due to MET amplification, a known resistance mechanism. Participants will receive daily doses of Lazertinib 240 mg and Tepotinib 500 mg based on MET FISH test results indicating MET amplification. This single-arm study aims to assess the clinical effectiveness of this combination therapy in overcoming resistance in patients with advanced or metastatic NSCLC. Treatment continues with close monitoring for response. During the study, participants will undergo molecular testing including tissue and blood sample collection at baseline and at disease progression, with re-biopsy planned for progression points. Researchers will measure the objective response rate (ORR) nine months after enrollment completion and track progression-free survival, duration of response, disease control rate, and overall survival up to 60 months. Safety and organ function will be regularly monitored throughout the trial, which may last several years.
CONDITIONS
Brief Title
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer not suitable for curative treatment
- Confirmed EGFR mutation (exon 19 deletion, L858R) with acquired resistance after first-line Lazertinib treatment
- Prior first-line cytotoxic chemotherapy allowed after Lazertinib failure
- MET amplification confirmed by FISH with gene copy number ≥5 and/or MET/CEP7 ratio ≥2
- Available tissue for MET FISH testing
- Age 19 years or older
- Eastern Cooperative Oncology Group performance status 0 to 2
- Expected life expectancy of at least 12 weeks
- Adequate organ function including neutrophil count ≥1500 cells/mm3, platelet count ≥100,000 cells/mm3, bilirubin ≤1.5x ULN, AST and ALT ≤2.5x ULN (or ≤5x ULN with liver metastasis), creatinine ≤1.5x ULN or creatinine clearance ≥45 mL/min
- Willingness to provide tissue and blood samples for genomic tests
- Agreement to perform re-biopsy at disease progression
- Female participants must be of non-reproductive potential
- Willing and able to comply with study protocol
- Signed informed consent
You will not qualify if you...
- Prior treatment with any EGFR tyrosine kinase inhibitor other than Lazertinib
- Concurrent or active other malignant tumors requiring systemic therapy within 2 years, unless cured
- Uncontrolled central nervous system metastases
- Spinal cord compression or leptomeningeal carcinomatosis
- Uncontrolled systemic illness including hypertension, bleeding, or infection
- Recent radiotherapy within 2 weeks (wide field) or 1 week (localized)
- Unresolved toxicities greater than grade 1 from prior therapy
- History of interstitial lung disease or ILD-like symptoms
- QTc interval ≥470 ms
- No measurable tumor lesion
- Inability to swallow the study drugs due to nausea, vomiting, or chronic gastrointestinal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or unacceptable toxicity
Participants receive daily treatment with Lazertinib and Tepotinib to manage their EGFR mutant non-small cell lung cancer with MET overexpression or amplification after progression on prior Lazertinib treatment.
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351
Actively Recruiting
Research Team
M
Myung-Ju Ahn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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