Actively Recruiting
Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
Led by Peking University Cancer Hospital & Institute · Updated on 2025-07-25
42
Participants Needed
12
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older, male or female
- Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC (stage IIIB, IIIC, or IV)
- Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation)
- Disease progression after prior EGFR-TKI therapy with 31 prior chemotherapy regimen (anti-angiogenic therapy or PD-1/PD-L1 inhibitors allowed during prior therapy)
- Objective clinical benefit during previous EGFR-TKI therapy (partial/complete response or stable disease >6 months)
- Confirmed c-Met amplification by blood test or biopsy
- ECOG performance status of 0 or 1
- At least one target lesion per RECIST v1.1
- Laboratory values within specified limits including neutrophils, hemoglobin, platelets, bilirubin, liver enzymes, creatinine clearance, INR, amylase, and lipase
- Use of effective contraception for men and women of childbearing potential; negative pregnancy test for women of childbearing potential
- Expected survival of at least 3 months
You will not qualify if you...
- Presence of ALK fusion or ROS1 fusion
- Spinal cord compression, leptomeningeal metastasis, or symptomatic brain metastasis requiring increased steroids (controlled symptomatic CNS metastases allowed)
- Other malignancies except certain completely resected cancers or those disease-free for at least 3 years
- Recent anti-tumor treatments including specific traditional medicines, radiotherapy, or major surgery within specified timeframes
- Unresolved toxicities from prior treatments above Grade 1 except alopecia or permanent radiation injury
- Use of strong CYP3A4 inhibitors or inducers within 1 week prior and during study
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, certain viral infections, active keratitis or tuberculosis, active infection requiring antibiotics, or severe psychiatric disorders
- Cardiac dysfunction including prolonged QT interval, significant arrhythmias, heart failure NYHA class 3, or LVEF <50%
- History or active interstitial lung disease or radiation pneumonitis requiring corticosteroids
- Coagulation dysfunction or bleeding tendency
- Difficulty swallowing or major GI surgery affecting drug absorption
- Pleural, pericardial effusion, or ascites requiring drainage within 4 weeks
- Significant systemic diseases requiring treatment or affecting compliance
- History of pancreatitis or pancreatic surgery or risk factors for pancreatitis
- Receiving thrombolytic therapy (stable anticoagulant therapy allowed)
- Known hypersensitivity to study drugs
- Pregnant or breastfeeding women
- Participation in another study within 2 weeks
- Cognitive impairment limiting consent or compliance
- Any condition increasing risk or affecting study results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Ordos Central Hospital
Neimeng, Neimeng, China
Not Yet Recruiting
2
Peking University Cancer Hospital (Inner Mongolia Campus)
Neimeng, Neimeng, China
Not Yet Recruiting
3
Affiliated Hospital of Hebei University
Baoding, China
Not Yet Recruiting
4
Baotou Cancer Hospital
Baotou, China
Actively Recruiting
5
Peking University Cancer Hospital & Institute
Beijing, China, 100142
Actively Recruiting
6
Beijing Chest Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
7
Beijing Daxing District People's Hospital
Beijing, China
Not Yet Recruiting
8
Peking Union Medical College Hospital
Beijing, China
Not Yet Recruiting
9
Peking University People's Hospital
Beijing, China
Not Yet Recruiting
10
Peking University Third Hospital
Beijing, China
Not Yet Recruiting
11
The Second Hospital of Dalian Medical University
Dalian, China
Not Yet Recruiting
12
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Not Yet Recruiting
Research Team
M
Minglei Zhuo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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