OncoMatch/Clinical Trials/NCT07809256
A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation
Official title: LPR-2: A Prospective, Single-center, Non-randomized, Interventional Study on the Effectiveness and Safety of Combined Immunotargeted Therapy in Patients With Metastatic Non-small Cell Cancer With a RET Gene Translocation
Is NCT07809256 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies lenvatinib pembrolizumab for nsclc (non-small cell lung cancer)r.
Treatment: lenvatinib pembrolizumab — This interventional study will evaluate the effectiveness, safety, and tolerability of pembrolizumab in combination with lenvatinib in adults with metastatic non-small cell lung cancer (NSCLC) who have a confirmed RET gene rearrangement and whose disease has progressed after one or more previous systemic treatments. Participants will receive pembrolizumab intravenously once every 3 weeks in combination with lenvatinib taken by mouth daily until disease progression, unacceptable side effects, or treatment discontinuation. Tumor response will be assessed using imaging studies according to RECIST 1.1, and participants will be monitored for treatment-related side effects, progression-free survival, and overall survival. The study will also evaluate clinical and tumor characteristics, RET rearrangement variants, and the diagnostic methods used to confirm RET-positive status.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: RET rearrangement
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy or targeted therapy for metastatic NSCLC — metastatic NSCLC
previously received treatment for metastatic NSCLC and have experienced disease progression during or after at least one previous line of standard systemic chemotherapy or targeted therapy
Must have received: platinum-based chemotherapy for metastatic NSCLC — metastatic NSCLC
previously received platinum-containing chemotherapy for metastatic NSCLC and have experienced disease progression during or after this treatment
Cannot have received: VEGFR inhibitor (lenvatinib)
previously received treatment with lenvatinib
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; platelets ≥100 × 10^9/L; hemoglobin ≥90 g/L; no transfusion within 14 days before starting study treatment
Kidney function
serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min; eGFR may be used
Liver function
total bilirubin ≤1.5x ULN (≤3x ULN if Gilbert syndrome); AST/ALT <3x ULN (or <5x ULN with liver metastases); ALP <3x ULN (or <5x ULN with liver/bone metastases)
adequate blood cell counts at screening...adequate liver function at screening...adequate kidney function at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07809256 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior VEGFR inhibitor disqualifies patients from enrollment.
Does this trial require RET?
Yes, RET rearrangement is a required biomarker for enrollment.
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