Vebreltinib with furmonertinib for advanced lung cancer with EGFR mutations and high PD-L1
Tests vebreltinib plus furmonertinib in adults with advanced EGFR-mutated non-small cell lung cancer.
Key facts
- Who runs it
- Second Affiliated Hospital of Nanchang University
- Where
- Nanchang, ChinaSee the site
- Trial code
- Registry title
- Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 45 people, planned
- Started
- 3 Jul 2026
- Expected to end
- 3 Jun 2029
- Type of study
- Interventional
- Treatments tested
- Vebreltinib
- Furmonertinib 80mg
- Record updated
- 18 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced lung cancer (non-small cell) who have an EGFR mutation and high PD-L1, and who have not had drug treatment for advanced disease yet.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer that is locally advanced (stage IIIB-IIIC), metastatic or recurrent (stage IV), and cannot be treated with surgery or full chemoradiotherapy. At least one tumour must be measurable on scans.
- Earlier treatment
- No earlier drug cancer treatment for advanced or metastatic disease. No earlier treatment with any EGFR-TKI or MET-TKI. Treated stable brain metastases are allowed.
- Biomarker or test result
- An EGFR mutation (exon 19 deletion or exon 21 L858R point mutation) and a PD-L1 Tumor Proportion Score (TPS) of 50% or more, confirmed by a central laboratory.
Main reasons for not taking part
- Small cell lung cancer or mixed small cell lung cancer
- ALK fusion or ROS1 fusion positive tumour
- Other active cancer (with a few exceptions)
- Heart problems, such as QTcF above 470ms or LVEF below 50%
- Swallowing problems, active digestive disease or past major stomach or bowel surgery that may affect drug absorption
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- 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%
- 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)
- Presence of ALK fusion positive or ROS1 fusion positive
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Jian Li, PhDTaking people
About the trial
What the trial wants to find out
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%.
Read full original descriptionShow less
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.
The group in the trial
- Vebreltinib plus FurmonertinibTreatment being tested
Participants with EGFR-sensitizing mutated, PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) will receive Vebreltinib at the recommended phase 2 dose (RP2D) orally in combination with furmonertinib 80 mg orally once daily, until disease progression or unacceptable toxicity.
Treatment: Vebreltinib and Furmonertinib 80mg
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Vebreltinib with furmonertinib for advanced lung cancer with EGFR mutations and high PD-L1Generated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07655622, who can take part
- Record updated
- 18 June 2026