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

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 par

Trial Details

NCT ID
NCT07655622
Phase
PHASE1 / PHASE2
Sponsor
Second Affiliated Hospital of Nanchang University
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Vebreltinib
  • Furmonertinib 80mg
Locations (sample)
  • Nanchang, Jianxi, China|28.68396,115.85306

Key Eligibility Criteria

  • Voluntarily agree to participate in this study and sign a written informed consent form
  • Age ≥18 years and ≤75 years, regardless of gender
  • Histologically or cytologically confirmed locally advanced (stage IIIB-IIIC), metastatic, or recurrent (stage IV) non-small cell lung cancer, not a…
  • No prior systemic antineoplastic therapy for advanced/metastatic disease Histologically or cytologically confirmed EGFR-sensitive mutations (exon 1…

For full eligibility, visit ClinicalTrials.gov.

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