Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification Af… (NCT07087223) | Clinical Trial Compass
RecruitingPhase 1/2
Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
China42 participantsStarted 2025-04-08
Plain-language summary
The goal of phase Ib study was to evaluate efficacy and tolerability of the combination of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) and (recommended Phase 2 dose) RP2D of vebreltinib with furmonertinib.
The goal of phase II study was to evaluate efficacy \[overall response rate (ORR), progression-free survival (PFS), and so on\] of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer with c-met amplification after failure of EGFR-TKI treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure.
. Aged ≥18 years, male or female.
. Patients with histologically or cytologically confirmed unresectable and non-suitable for radical surgery, or concurrent chemoradiotherapy , locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC;
. Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria:
. For tumor tissue samples, FISH detection shows GCN ≥5 and/or MET/CEP7 ≥2 (FISH results from local testing institutions/central laboratories are acceptable);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
phase Ib: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Timeframe: 12 months
2
phase Ib: maximum tolerated dose (MTD)
Timeframe: 12 months
3
phase Ib: Recommended Phase II Dose (RP2D)
Timeframe: 12 months
4
phase II: Overall Response Rate (ORR）
Timeframe: 24 months
Trial details
NCT IDNCT07087223
SponsorPeking University Cancer Hospital & Institute
. Tissue (wax blocks from pleural effusion centrifugation, if quality-controlled) or blood NGS testing results confirm c-Met amplification with CN ≥2.3 (NGS results from local testing institutions/central laboratories are acceptable for both tissue and blood).
. Absolute neutrophil count ≥1.5×10⁹/L (without the use of growth factors within 7 days prior to the start of treatment);
Exclusion criteria
. Patients with ALK fusion or ROS1 fusion.
. Patients with spinal cord compression, leptomeningeal metastasis, or symptomatic brain metastasis that requires an increase in steroid dosage to control central nervous system disease. Patients with symptomatic CNS metastases that have been controlled may be eligible for this trial.
. Presence of other malignancies (with the exception of any type of carcinoma in situ that has been completely resected, basal cell and squamous cell skin cancers, or other tumors/cancers that have been treated with curative intent and have been disease-free for at least 3 years).
. A history of anti-tumor treatment that meets any of the following criteria:
. Uncontrolled hypertension, with the allowance for the initiation or adjustment of antihypertensive medications prior to screening;
. Positive for anti-HIV, or positive for both anti-HCV and HCV-RNA, or positive for HBsAg with HBV-DNA ≥500 IU/mL
. Active keratitis or ulcerative keratitis during the disease phase;