OncoMatch/Clinical Trials/NCT07655622
Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression
Is NCT07655622 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1/2 trial studies multiple treatments including Vebreltinib and Furmonertinib 80mg for non-small-cell lung cancer.
Treatment: Vebreltinib · Furmonertinib 80mg — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R point mutation)
Required: EGFR l858r
EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R point mutation)
Required: PD-L1 (CD274) overexpression (TPS ≥50%)
Central laboratory-confirmed PD-L1 Tumor Proportion Score (TPS) ≥50%
Excluded: ALK fusion
Presence of ALK fusion positive
Excluded: ROS1 fusion
Presence of ...ROS1 fusion positive
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with any EGFR-TKI
Cannot have received: MET inhibitor
Prior treatment with any ...MET-TKI
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
QTcF >470ms (average of three ECGs) at screening; NYHA functional class ≥3 or LVEF <50%
Adequate organ function; Cardiac dysfunction: QTcF >470ms (average of three ECGs) at screening; NYHA functional class ≥3 or LVEF <50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07655622 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
Are patients with ROS1 alterations eligible?
No. ROS1 fusion is an exclusion criterion.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualify