NCT07655622RecruitingPhase 1/2
Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 3 Jul 2026
- Primary completion date
- 3 Dec 2027
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Diseases
- Lung cancer
- NCT number
- NCT07655622
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 45
- From 3 Jul 2026 to the primary completion date, 3 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Require use of strong CYP3A4 inhibitors or inducers within 1 week before first dose or during the study
Other illness
- Histological type of small cell lung cancer or mixed small cell lung cancer
- Uncontrolled systemic diseases
- Dysphagia, active digestive system disease, or history of major gastrointestinal surgery that may affect drug absorption
- History of acute or chronic pancreatitis or pancreatic surgery
- Other conditions deemed unsuitable for participation by the investigator
Lab values
- Prior treatment with any EGFR-TKI or MET-TKI
- Cardiac dysfunction: QTcF \>470ms (average of three ECGs) at screening; NYHA functional class ≥3 or LVEF \<50%
Age
- 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)
Other
- Presence of ALK fusion positive or ROS1 fusion positive
Who the study is looking for
- 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 amenable to surgical resection and definitive concurrent chemoradiotherapy
- 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)
- Central laboratory-confirmed PD-L1 Tumor Proportion Score (TPS) ≥50%
- At least one measurable target lesion according to RECIST v1.1 criteria
- Asymptomatic or locally treated stable brain metastases are allowed.
- ECOG performance status 0-1
- Expected survival ≥3 months
- Adequate organ function
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.