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RECRUITING

NCT07655622

PHASE1/PHASE2

Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

This is a single-arm, exploratory phase Ib/II study with a seamless design to evaluate the safety and efficacy of Vebreltinib combined with furmonertinib as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitive mutations (exon 19 deletion or L858R) and PD-L1 TPS ≥50%. In the phase Ib part, 12-16 patients will be enrolled to compare the safety and early efficacy of Vebreltinib 100mg BID versus 150mg BID in combination with furmonertinib 80mg QD, and to determine the recommended phase II dose (RP2D). In the phase II part, 37 patients (including evaluable patients from the RP2D cohort in phase Ib) will receive treatment at the RP2D. The primary endpoint is investigator-assessed median progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. Exploratory endpoints will analyze the correlation between baseline MET abnormalities and treatment efficacy.

Official title: A Single-arm, Phase I/II Trial Aimed to Evaluate the Efficacy and Safety of Vebreltinib Plus Furmonertinb as First-line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Mutations and High PD-L1 Expression

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-03

Completion Date

2029-06-03

Last Updated

2026-06-18

Healthy Volunteers

Conditions

Non-Small-Cell Lung Cancer

Interventions

DRUG

Vebreltinib

Administered orally on an empty stomach, 100mg or 150mg twice daily, with an interval of 12±4 hours between morning and evening doses. Dose adjustments are allowed based on toxicity, down to a minimum of 100mg BID

DRUG

Furmonertinib 80mg

Administered orally on an empty stomach, 80mg once daily, taken concurrently with Vebreltinib.

Inclusion Criteria: 1. Voluntarily agree to participate in this study and sign a written informed consent form 2. Age ≥18 years and ≤75 years, regardless of gender 3. Histologically or cytologically confirmed locally advanced (stage IIIB-IIIC), metastatic, or recurrent (stage IV) non-small cell lung cancer, not amenable to surgical resection and definitive concurrent chemoradiotherapy 4. No prior systemic antineoplastic therapy for advanced/metastatic disease Histologically or cytologically confirmed EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R point mutation) 5. Central laboratory-confirmed PD-L1 Tumor Proportion Score (TPS) ≥50% 6. At least one measurable target lesion according to RECIST v1.1 criteria 7. Asymptomatic or locally treated stable brain metastases are allowed. 8. ECOG performance status 0-1 9. Expected survival ≥3 months 10. Adequate organ function Exclusion Criteria: 1. Histological type of small cell lung cancer or mixed small cell lung cancer 2. Prior treatment with any EGFR-TKI or MET-TKI 3. Presence of ALK fusion positive or ROS1 fusion positive 4. Other active malignant tumors (except completely resected carcinoma in situ, basal cell or squamous cell skin cancer, or tumors with no recurrence for ≥3 years after curative treatment) 5. Major surgery within 4 weeks before first dose (except brain metastasis resection, which requires ≥2 weeks); thoracoscopic biopsy or mediastinoscopy is excluded (requires ≥1 week) 6. Require use of strong CYP3A4 inhibitors or inducers within 1 week before first dose or during the study 7. Uncontrolled systemic diseases 8. Cardiac dysfunction: QTcF \>470ms (average of three ECGs) at screening; NYHA functional class ≥3 or LVEF \<50% 9. Dysphagia, active digestive system disease, or history of major gastrointestinal surgery that may affect drug absorption 10. History of acute or chronic pancreatitis or pancreatic surgery 11. Other conditions deemed unsuitable for participation by the investigator

Locations (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jianxi, China