Non Small Cell Lung Cancer NSCLCPhase 1/2NCT07087223
Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
A Phase 1/2 study testing Vebreltinib combined with Furmonertinib in people with Non Small Cell Lung Cancer NSCLC, run by Peking University Cancer Hospital & Institute at 12 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer NSCLC
- What is being tested?
- Vebreltinib combined with Furmonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 12 sitesChina
- Study dates
- 8 Apr 2025to Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria:
- ≤1 prior chemotherapy regimen allowed besides EGFR-TKI. Combination with anti-angiogenic therapy or PD-1/PD-L1 inhibitors are allowed during EGFR-TKI targeted therapy or chemotherapy.
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- （2） Objective clinical benefit documented during previous EGFR-TKI therapy, defined by either partial or complete radiological response, or durable stable disease should be greater than 6 months after initiation of EGFR-TKI.
- 6. After the last line of treatment before enrollment, progression is confirmed, and blood tests confirm c-Met amplification, or re-biopsy and genetic testing confirm c-Met amplification. Any of the following criteria define c-Met amplification.
- For tumor tissue samples, FISH detection shows GCN ≥5 and/or MET/CEP7 ≥2 (FISH results from local testing institutions/central laboratories are acceptable);
- 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).
- 7. ECOG performance status ≤1. 8. According to RECIST v1.1, the patient must have at least one target lesion as assessed by the investigator.
- 9. Laboratory test results must meet the following criteria:
- Absolute neutrophil count ≥1.5×10⁹/L (without the use of growth factors within 7 days prior to the start of treatment);
- Hemoglobin ≥90 g/L (without blood transfusion or use of growth factors within 7 days prior to the start of treatment);
- Platelet count ≥75×10⁹/L (without blood transfusion or use of growth factors within 7 days prior to the start of treatment);
- Serum total bilirubin ≤1.5×upper limit of normal (ULN);
- Serum alanine aminotransferase and aspartate aminotransferase ≤3×ULN (for patients with liver metastases, both AST and ALT ≤5×ULN);
- Creatinine clearance (Ccr) ≥60 mL/min.
- International normalized ratio (INR) ≤1.5×ULN;
- Asymptomatic serum amylase ≤Grade 2 (NCI-CTCAE v5.0). For patients with Grade 2 serum amylase abnormalities at the start of the study, it must be confirmed that there are no signs and/or symptoms suggestive of pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging results);
- Serum lipase ≤1.5×ULN. 10. Men with reproductive potential and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test within ≤7 days prior to the first dose of the study drug. This does not apply to female subjects who have undergone sterilization or are postmenopausal.
- 11. Expected survival ≥3 months.
Who cannot join
- 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:
- （1）Received traditional Chinese medicine or patent medicine with anti-tumor indications within 1 week prior to the first dose of the study drug; （2）Underwent radiotherapy targeting the lung fields and whole brain within 4 weeks prior to the first dose of the study drug, or received radiotherapy targeting other areas (excluding the lung fields and whole brain) within 2 weeks prior to the first dose. Palliative radiotherapy for bone metastases to relieve pain or prevent skeletal-related events is excluded; （3）Underwent major surgery within 4 weeks, or has not recovered from the adverse effects of these surgeries. Thoracoscopic biopsy and mediastinoscopy are not considered major surgeries, and patients may be enrolled ≥1 week after the procedure 5. Has not recovered from any toxicity or complications of prior chemotherapy, surgery, radiotherapy, or other anti-tumor treatments, i.e., not reduced to ≤Grade 1 (NCI-CTCAE v5.0), with the exception of alopecia and permanent radiation-induced damage that cannot be recovered; 6. Requires the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme 1 week prior to the first dose of the study drug and during the study period.
- 7. Has any severe or uncontrolled systemic disease, including but not limited to:
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- 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;
- Active tuberculosis;
- Active infection requiring systemic antimicrobial therapy within 2 weeks prior to the first dose of the study drug;
- Other severe medical conditions or psychiatric disorders, or laboratory abnormalities that, in the investigator's judgment, make the study drug unsuitable for the patient or affect protocol compliance; 8. Cardiac dysfunction and diseases that meet any of the following criteria:
- （1）The average corrected QT interval calculated by the Fridericia formula from three electrocardiograms during the screening period >470 ms; （2）Any significant arrhythmias, such as ventricular arrhythmias, uncontrolled supraventricular or junctional arrhythmias, and other uncontrolled cardiac arrhythmias （3）Any risk factors for QTc prolongation, such as severe hypokalemia, hereditary long QT syndrome, or use of drugs that prolong the QT interval; d) Congestive heart failure with New York Heart Association (NYHA) classification ≥3; echocardiography indicating left ventricular ejection fraction (LVEF) <50%； 9. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring corticosteroid therapy, or is currently receiving drug therapy or other clinical interventions, or has active interstitial lung disease; 10. Has coagulation dysfunction or bleeding tendency 11. Has difficulty swallowing, or has active gastrointestinal disease, or has undergone major gastrointestinal surgery that may significantly affect the intake or absorption of the study drug 12. Has pleural effusion, pericardial effusion, or ascites that require drainage and/or are associated with dyspnea within 4 weeks prior to the first dose of the study drug; 13. Has any clinically significant systemic disease that requires treatment, as judged by the investigator, including but not limited to thyroid disease, organ transplant recipients, history of psychiatric disorders, history of drug abuse/addiction, alcoholism, or drug use; 14. History of acute or chronic pancreatitis, pancreatic surgery, or risk factors that may increase the risk of pancreatitis; 15. Patients receiving thrombolytic therapy are not eligible for inclusion, but patients receiving anticoagulant therapy may be included, provided that they have been on a stable dose of anticoagulant therapy for at least 1 week prior to the first dose; 16. Has a known hypersensitivity to the study drug or its excipients; 17. Pregnant or breastfeeding women; 18. Currently enrolled in another study device or study drug treatment, or received other study drugs or study devices within 2 weeks prior to the first dose of the study drug; 19. Cognitive impairment that may limit their understanding or execution of the informed consent form; 20. Presence of any condition that may increase the risk associated with the administration of the study drug, or may affect the interpretation of study results, or poor compliance with the study protocol, or any other situation that the investigator deems unsuitable for enrollment.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Affiliated Hospital of Hebei University
Baoding
- Recruiting
Baotou Cancer Hospital
Baotou
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, 100142
Minglei Zhuo, +86 88196456, minglei1978@163.com
- Not yet recruiting
Beijing Chest Hospital, Capital Medical University
Beijing
- Not yet recruiting
Beijing Daxing District People's Hospital
Beijing
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
- Not yet recruiting
Peking University People's Hospital
Beijing
- Not yet recruiting
Peking University Third Hospital
Beijing
- Not yet recruiting
The Second Hospital of Dalian Medical University
Dalian
- Not yet recruiting
Ordos Central Hospital
Neimeng, Neimeng
- Not yet recruiting
Peking University Cancer Hospital (Inner Mongolia Campus)
Neimeng, Neimeng
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
About this study
Official title: The Open-Label, Multicenter Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Vebreltinib Combined With Furmonertinib in Locally Advanced or Metastatic NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
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.
Read the detailed description
Phase Ib study uses 3+3 clinical design. The Phase Ib clinical trial is designed to explore the dosing of vebreltinib, consisting of two stages: dose escalation and dose expansion. The dose escalation stage follows a 3+3 design with three escalating dose levels (100 mg BID, 150 mg BID, 200 mg BID). Each dose cohort enrolls 3 patients. If no DLTs are observed in the first 3 patients within 28 days, the dose is escalated to the next cohort. If more than 1 DLT is observed in the first 3 patients within 28 days, that dose level is deemed non-tolerable. If 1 DLT is observed in the first 3 patients within 28 days, an additional 3 patients are enrolled at that dose level. If no DLTs are observed in the additional patients, dose escalation proceeds to the next cohort. If more than 1 DLT is observed among the additional patients (i.e., a total of 2 DLTs in the cohort), the previous dose level is determined to be the MTD. After completion of DLT assessment, the investigator decided whether to continue the treatment after the end of DLT assessment based on the subject 's tolerance and the safety profile of the dose group.
The dose expansion phase, based on the safety data from the completed dose cohorts, will involve the selection of 1-2 dose cohorts by the investigators for further study. Approximately 10 additional subjects will be enrolled in each selected dose expansion cohort to determine the recommended dose for Phase II clinical trials.
In the Phase II clinical study, the recommended Phase II dose of vebreltinib, determined from the Phase Ib study, will be combined with Furmonertinib to treat locally advanced or metastatic NSCLC with c-Met amplification in patients after failure of EGFR-TKI treatment. The study aims to evaluate the efficacy and safety of this combination, with an anticipated enrollment of 20 subjects. Participants will take vebreltinib (RP2D bid) and furmonertinib (80mg qd) until disease progression or undurable toxicity.
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Being tested
- Vebreltinib combined with Furmonertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vebreltinib combined with FurmonertinibDrug
Vebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily
Vebreltinib combined with FurmonertinibDrug
Vebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily. Based on the safety data from the completed dose cohorts, the investigators will involve the selection of 1-2 dose cohorts for further study. Approximately 10 additional subjects will be enrolled in the selected dose expansion cohort to determine the recommended dose for Phase II clinical trials.
Vebreltinib combined with FurmonertinibDrug
RP2D of Vebreltinib as determined during Phase Ib oral twice daily combined with Furmonertinib 80mg oral once daily
| Study group | Role | What they receive |
|---|---|---|
| phase Ib Dose Escalation | Experimental | Not described Receives: Drug: Vebreltinib combined with Furmonertinib |
| phase Ib Dose Expansion | Experimental | Not described Receives: Drug: Vebreltinib combined with Furmonertinib |
| phase II | Experimental | Not described Receives: Drug: Vebreltinib combined with Furmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase Ib: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of Vebreltinib combined with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
Measured: 12 months
phase Ib: maximum tolerated dose (MTD)
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of Vebreltinib combined with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
Measured: 12 months
phase Ib: Recommended Phase II Dose (RP2D)
To determine the recommended phase II dose (RP2D) of Vebreltinib in combination with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
Measured: 12 months
phase II: Overall Response Rate (ORR）
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: 24 months
Secondary outcomes (6)
phase II: Progression Free Survival(PFS)
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: 24 months
phase II: Duration of Response(DOR)
DOR is defined as the time from the first occurrence of a objective response to the time of documented disease progression, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1
Measured: 24 months
phase II: Disease Control Rate(DCR)
DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.
Measured: 24 months
phase II: Overall Survival(OS)
OS is defined as the time from first dose until the date of death due to any cause
Measured: 60 months
phase II: adverse events
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), etc, which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Measured: Through study completion, an average of 2 year
phase II: health-related quality of life
An EQ-5D-5L health survey questionnaire will be conducted before treatment, at each visit, and at the end of treatment to assess the impact of treatment on the patient's disease-related symptoms and health-related quality of life. The questionnaire will stop once the patient withdraws from the study. The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L profile defines health in terms of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has five levels: 1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, and 5: extreme problems. The responses were used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 was the worst health you can imagine and 100 was the best health you can imagine.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start8 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer NSCLCStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087223
- Sponsor's protocol ID
- 2024YJZ133
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Open-Label, Multicenter Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Vebreltinib Combined With Furmonertinib in Locally Advanced or Metastatic NSCLC Patients With c-Met Amplification After EGFR-TKI Failure
- ClinicalTrials.gov ID
- NCT07087223
- Acronym / sponsor ID
- 2024YJZ133
- Conditions
- Non Small Cell Lung Cancer NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase Ib study uses 3+3 clinical design. The Phase Ib clinical trial is designed to explore the dosing of vebreltinib, consisting of two stages: dose escalation and dose expansion. The dose escalation stage follows a 3+3 design with three escalating dose levels (100 mg BID, 150 mg BID, 200 mg BID). Each dose cohort enrolls 3 patients. If no DLTs are observed in the first 3 patients within 28 days, the dose is escalated to the next cohort. If more than 1 DLT is observed in the first 3 patients within 28 days, that dose level is deemed non-tolerable. If 1 DLT is observed in the first 3 patients within 28 days, an additional 3 patients are enrolled at that dose level. If no DLTs are observed in the additional patients, dose escalation proceeds to the next cohort. If more than 1 DLT is observed among the additional patients (i.e., a total of 2 DLTs in the cohort), the previous dose level is determined to be the MTD. After completion of DLT assessment, the investigator decided whether to continue the treatment after the end of DLT assessment based on the subject 's tolerance and the safety profile of the dose group.
The dose expansion phase, based on the safety data from the completed dose cohorts, will involve the selection of 1-2 dose cohorts by the investigators for further study. Approximately 10 additional subjects will be enrolled in each selected dose expansion cohort to determine the recommended dose for Phase II clinical trials.
In the Phase II clinical study, the recommended Phase II dose of vebreltinib, determined from the Phase Ib study, will be combined with Furmonertinib to treat locally advanced or metastatic NSCLC with c-Met amplification in patients after failure of EGFR-TKI treatment. The study aims to evaluate the efficacy and safety of this combination, with an anticipated enrollment of 20 subjects. Participants will take vebreltinib (RP2D bid) and furmonertinib (80mg qd) until disease progression or undurable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phase Ib Dose Escalation | Experimental | Drug: Vebreltinib combined with Furmonertinib |
| phase Ib Dose Expansion | Experimental | Drug: Vebreltinib combined with Furmonertinib |
| phase II | Experimental | Drug: Vebreltinib combined with Furmonertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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;
- Documented EGFR sensitive mutations (exon 19 deletion or exon 21 L858R mutation).
- Disease progression after prior EGFR-TKI therapy. Participants must meet both of the following 2 criteria:
Key exclusion criteria (13 listed)
- 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:
- （1）Received traditional Chinese medicine or patent medicine with anti-tumor indications within 1 week prior to the first dose of the study drug; （2）Underwent radiotherapy targeting the lung fields and whole brain within 4 weeks prior to the first dose of the study drug, or received radiotherapy targeting other areas (excluding the lung fields and whole brain) within 2 weeks prior to the first dose. Palliative radiotherapy for bone metastases to relieve pain or prevent skeletal-related events is excluded; （3）Underwent major surgery within 4 weeks, or has not recovered from the adverse effects of these surgeries. Thoracoscopic biopsy and mediastinoscopy are not considered major surgeries, and patients may be enrolled ≥1 week after the procedure 5. Has not recovered from any toxicity or complications of prior chemotherapy, surgery, radiotherapy, or other anti-tumor treatments, i.e., not reduced to ≤Grade 1 (NCI-CTCAE v5.0), with the exception of alopecia and permanent radiation-induced damage that cannot be recovered; 6. Requires the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme 1 week prior to the first dose of the study drug and during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vebreltinib combined with FurmonertinibVebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily | Drug | phase Ib Dose Escalation |
| Vebreltinib combined with FurmonertinibVebreltinib 100mg/1500mg/200mg oral twice daily combined with Furmonertinib 80mg oral once daily. Based on the safety data from the completed dose cohorts, the investigators will involve the selection of 1-2 dose cohorts for further study. Approximately 10 additional subjects will be enrolled in the selected dose expansion cohort to determine the recommended dose for Phase II clinical trials. | Drug | phase Ib Dose Expansion |
| Vebreltinib combined with FurmonertinibRP2D of Vebreltinib as determined during Phase Ib oral twice daily combined with Furmonertinib 80mg oral once daily | Drug | phase II |
Primary outcome
phase Ib: Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: 12 months
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of Vebreltinib combined with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
phase Ib: maximum tolerated dose (MTD)
Time frame: 12 months
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of Vebreltinib combined with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
phase Ib: Recommended Phase II Dose (RP2D)
Time frame: 12 months
To determine the recommended phase II dose (RP2D) of Vebreltinib in combination with Furmonertinib in locally advanced or metastatic NSCLC patients with c-Met amplification after EGFR-TKI failure
phase II: Overall Response Rate (ORR）
Time frame: 24 months
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1
6 secondary outcomes
phase II: Progression Free Survival(PFS)
Time frame: 24 months
phase II: Duration of Response(DOR)
Time frame: 24 months
phase II: Disease Control Rate(DCR)
Time frame: 24 months
phase II: Overall Survival(OS)
Time frame: 60 months
phase II: adverse events
Time frame: Through study completion, an average of 2 year
phase II: health-related quality of life
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vebreltinib combined with Furmonertinib in people with Non Small Cell Lung Cancer NSCLC, run by Peking University Cancer Hospital & Institute at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minglei Zhuo (+86 88196456, minglei1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase Ib: Incidence of dose-limiting toxicities (DLT) as defined in the protocol (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.