OncoMatch/Clinical Trials/NCT05989542
A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)
Is NCT05989542 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies PLB1001 for non-small cell lung cancer.
Treatment: PLB1001 — The goal of this clinical trial is to test if PLB1001 works well and safely in Non-small cell lung cancer patients with MET exon 14 mutation. The main questions it aims to answer are: * If it is works well in Non-small cell lung cancer patients with MET exon 14 mutation * If it is safety and tolerant in Non-small cell lung cancer patients with MET exon 14 mutation Participants will 1. be given PLB1001 200mg BID,oral. 2. be received hematology and urine and ECG examinations every 14 days (First 3 months) or every 28 days (After 3 months) 3. be received Image examination every 8 weeks(First year) or every 12 weeks(After one year)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET exon 14 skipping mutation
The presence of MET exon 14 jump mutation was confirmed by the NGS test in the central laboratory
Required: EGFR wild-type
Tissue sample testing confirms EGFR wild-type
Required: ALK wild-type
ALK rearrangement negative
Required: ROS1 wild-type
ROS1 rearrangement negative
Required: KRAS wild-type
KRAS mutation negative
Disease stage
Required: Stage IIIB, IIIC, IVA, IVB (AJCC 8th edition)
according to the AJCC 8th edition of lung cancer staging, Stage IIIB - Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: MET inhibitor
previous treatment with MET inhibitors
Cannot have received: HGF-targeted therapy
previous treatment with ... HGF-targeted therapy
Lab requirements
Blood counts
Platelet count ≥75 × 10⁹/L (no transfusion/growth factor within 10 days); ANC ≥ 1.5 × 10⁹/L (no growth factors within 10 days); Hemoglobin > 90 g/L (no transfusion/growth factors within 10 days); INR ≤ 2.0
Kidney function
Creatinine clearance (Ccr) >50 mL/min (Cockcroft-Gault formula); Urea/urea nitrogen ≤1.5 × ULN
Liver function
AST/ALT ≤ 3 x ULN (no liver metastases), ≤ 5 x ULN (with liver metastases); Total bilirubin ≤ 1.5 x ULN (no liver metastases), ≤ 3 x ULN (with liver metastases)
Laboratory tests that meet the following requirements: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05989542 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MET inhibitor, HGF-targeted therapy disqualifies patients from enrollment.
Does this trial require MET?
Yes, MET exon 14 skipping mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IVA or IVB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages