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NOT YET RECRUITING
NCT07894367
PHASE2

Gematinib Combined With Lenvatinib for the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Protein Overexpression: A Prospective, Multicenter, Phase II Clinical Study

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

Research objective: To evaluate the efficacy and safety of gematinib combined with lenvatinib in the treatment of advanced or metastatic NSCLC with MET overexpression that has failed standard therapy Experimental design: Prospective, multicenter, single-arm Study population: Patients with locally advanced or metastatic NSCLC who have overexpression of the MET protein (IHC 3+: ≥ 50% of tumor cells show strong positivity; IHC 2+: ≥ 50% of tumor cells show moderate positivity) Sample size: 23 cases (including 6 cases in the safety introduction period) Drug regimen: Gematinib: 300mg, orally, once daily; Lenvatinib: For patients with a body weight of less than 60 kg, 8 mg once daily; for patients with a body weight of 60 kg or more, 12 mg once daily. A 21-day cycle is used until disease progression, occurrence of intolerable adverse reactions, or the subject withdrawing from the study.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2026-09-30

Completion Date

2028-12-31

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

Gematinib

Gematinib: 300mg, orally, once daily. A 21-day cycle is used, until disease progression or the occurrence of intolerable adverse reactions or the subject withdrawing from the study.

DRUG

Lenvatinib

Lenvatinib: For patients with a body weight of less than 60 kg, 8 mg once daily; for patients with a body weight of 60 kg or more, 12 mg once daily. A 21-day cycle is used, until disease progression, occurrence of intolerable adverse reactions, or the subject withdrawing from the study.