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New treatment option for Non-Small-Cell Lung Cancer
Official title Vebreltinib Plus Furmonertinib in Patients With EGFR-mutated Advanced Non-small Cell Lung Cancer and High PD-L1 Expression
ClinicalTrials.gov ID: NCT07655622
What this study is testing
What is Vebreltinib?
Vebreltinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- No prior systemic antineoplastic therapy for advanced/metastatic disease Histologically or cytologically confirmed EGFR-sensitive mutations (exon 19...
- Central laboratory-confirmed PD-L1 Tumor Proportion Score (TPS) ≥50%
You likely can't join if
- Histological type of small cell lung cancer or mixed small cell lung cancer
- Prior treatment with any EGFR-TKI or MET-TKI
- Presence of ALK fusion positive or ROS1 fusion positive
- Other active malignant tumors (except completely resected carcinoma in situ, basal cell or squamous cell skin cancer, or tumors with no recurrence...
- Major surgery within 4 weeks before first dose (except brain metastasis resection, which requires ≥2 weeks); thoracoscopic biopsy or mediastinoscopy...
- Require use of strong CYP3A4 inhibitors or inducers within 1 week before first dose or during the study
See the full 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 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
- Histological type of small cell lung cancer or mixed small cell lung cancer
- Prior treatment with any EGFR-TKI or MET-TKI
- Presence of ALK fusion positive or ROS1 fusion positive
- 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)
- 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
- Uncontrolled systemic diseases
- Cardiac dysfunction: QTcF \>470ms (average of three ECGs) at screening; NYHA functional class ≥3 or LVEF \<50%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nanchang, Jianxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanchang, Jianxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.