Lung NeoplasmsPhase 2NCT07549061
Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC
A Phase 2 study testing Vebreltinib and Chemotherapy in people with Lung Neoplasms, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Vebreltinib and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to 30 Dec 2028
- Phase
- Phase 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
- Voluntarily sign a written informed consent form (ICF) to participate in the study; be willing and able to comply with study-related visits and procedures.
- Male or female subjects aged 18 years or older.
- Pathologically confirmed non-small cell lung cancer (NSCLC); outside hospital pathology reports are acceptable.
- Newly diagnosed metastatic NSCLC (clinical Stage IVA or IVB) or recurrent NSCLC (staged in accordance with the AJCC Cancer Staging Manual 9th edition), not eligible for curative-intent surgery or radiotherapy.
- Treatment-naïve advanced NSCLC not amenable to curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy/chemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted if completed at least 12 months before disease recurrence.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.
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- Driver gene-negative status confirmed by tumor tissue or blood sample, including but not limited to negative EGFR mutation, negative ALK rearrangement, negative ROS1 rearrangement, negative KRAS G12C mutation, and negative MET exon 14 skipping mutation. MET amplification is permitted: FISH demonstrating GCN ≥ 4 or MET/CEP7 ≥ 2, or positive result confirmed by NGS.
- MET protein overexpression defined as ≥50% of tumor cells staining at IHC 2++ or stronger. Local laboratory IHC results are acceptable.
- Estimated overall survival of at least 3 months.
- Laboratory values meeting the following requirements:
- Absolute neutrophil count (ANC)≥1.5 × 10⁹/L; Hemoglobin≥90 g/L; Platelets≥75 × 10⁹/L; Serum total bilirubin≤1.5×upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×ULN; for patients with liver metastases, AST and ALT≤5×ULN; Serum creatinine<1.5 × ULN. Creatinine clearance (CrCl)>50 mL/min, calculated using the Cockcroft-Gault formula
- Males with reproductive potential and females of childbearing potential must agree to use highly effective contraception from signing informed consent until 3 months after the last dose of study drug. For females of childbearing potential, a serum pregnancy test must be negative within ≤7 days before the first dose of study drug.
Who cannot join
- Spinal cord compression. Symptomatic or unstable brain metastases, unless the patient has completed curative treatment, is not receiving corticosteroid therapy, and has maintained a stable neurological status for at least 2 weeks after completion of curative treatment and steroid therapy. Patients with asymptomatic brain metastases may be included if the investigator determines there is no immediate indication for curative treatment.
- Meeting any of the following prior treatment history criteria:
- Major surgery (e.g., intrathoracic, intra-abdominal, or intrapelvic surgery) within 4 weeks prior to enrollment, or failure to recover from side effects of such surgery. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery, and patients may be enrolled 1 week after these procedures.
- Treatment with traditional Chinese medicine (TCM) or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose of study drug.
- Treatment with strong CYP3A4 inducers and/or strong inhibitors, and inability to discontinue such agents for at least 1 week prior to initiation of study treatment and during the study period.
- Prior systemic anti-tumor therapy for advanced NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational agent, administered as non-curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy/chemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted only if completed at least 12 months before disease recurrence.
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- Radiation therapy to more than 30% of bone marrow, or large-field radiation therapy within 4 weeks prior to the first dose of vebreltinib.
- Patients with intracranial lesions requiring urgent local treatment for symptom relief are recommended for exclusion, at the discretion of the investigator.
- Any severe or uncontrolled systemic disease, including but not limited to other severe medical or psychiatric disorders or laboratory abnormalities that, in the investigator's judgment, render the study drug inappropriate for the patient or impair compliance with the protocol.
- Meeting any of the following cardiac function or disease criteria:
- Mean corrected QT interval (QTc) > 470 ms based on three routine ECG assessments performed at least 5 minutes apart (preferably completed within 1 hour) during the screening period at rest. Calculation shall be performed using the Fridericia formula (see Appendix 5 for details), with mean QTcF > 470 ms.
- Any significant cardiac arrhythmia, such as complete left bundle branch block, second- or third-degree heart block, ventricular arrhythmia, drug-uncontrolled supraventricular or nodal arrhythmia, or other drug-uncontrolled cardiac arrhythmias.
- Any risk factors for prolonged QTc interval, including chronic hypokalemia uncorrected by supplementation, congenital long QT syndrome, and concomitant use of QTc-prolonging medications.
- Congestive heart failure of New York Heart Association (NYHA) Class ≥3. Unstable or uncontrolled diseases or conditions related to or affecting cardiac function (e.g., unstable angina pectoris, inadequately controlled hypertension defined as diastolic blood pressure > 100 mmHg and/or systolic blood pressure > 160 mmHg regardless of antihypertensive use; initiation or adjustment of antihypertensive agents prior to screening is permitted).
- Diagnosis of another active malignancy requiring treatment within the past 3 years, other than NSCLC. Excluded are completely resected basal cell and squamous cell skin cancer, and completely resected carcinoma in situ of any type.
- Presence of active infection, including but not limited to:
- Chronic hepatitis B (hepatitis B surface antigen [HBsAg] positive with hepatitis B virus [HBV] DNA ≥ 500 IU/ml), hepatitis C (positive anti-hepatitis C virus [HCV] antibody and positive HCV-RNA), human immunodeficiency virus (HIV) infection (positive HIV antibody), or syphilis infection.
- Active tuberculosis. Active infection requiring systemic anti-infective therapy (e.g., pneumonia) within 2 weeks prior to the first dose of study drug.
- History of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring corticosteroid therapy; or current active interstitial lung abnormalities requiring medical therapy or other clinical intervention.
- Active gastrointestinal disorders (e.g., ulcerative lesions, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) or other conditions (e.g., inability to swallow study medication, prior major gastrointestinal surgery) that may significantly affect absorption, distribution, metabolism, or excretion of oral study drug.
- Known hypersensitivity to drugs of the same class as the study drug or to any of its excipients.
- Any concurrent medical condition that may increase the risk of toxicity.
- Pregnant or lactating females.
- Current participation in another clinical trial, or receipt of investigational product within 2 weeks prior to the first dose of study drug.
- Any other circumstances deemed by the investigator to render the patient ineligible for study participation, including evidence of severe or uncontrolled systemic disease such as active primary immunodeficiency disorders and allogeneic organ transplantation, which would make the patient unsuitable for enrollment or interfere with compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
241 West Huaihai Road, Xuhui District, Shanghai, 200030, China.
Shanghai, Shanghai Municipality
About this study
Official title: A Phase II Study of Vebreltinib Combined With Platinum-Doublet Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Negative Driver Genes and MET Overexpression
To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.
Read the detailed description
This is a prospective, single-center, single-arm Phase II clinical study designed to investigate the efficacy and safety of vebreltinib combined with platinum-based chemotherapy in treatment-naïve patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.In this study, all eligible participants will provide written informed consent, and after meeting the inclusion and exclusion criteria during screening, will receive vebreltinib (150 mg orally Bid) plus platinum-doublet chemotherapy. Oral vebreltinib (150 mg Bid) will be continued until disease progression or unacceptable toxicity.
- Conditions
- Lung Neoplasms
- Being tested
- Vebreltinib, Chemotherapy
- Keywords
- NSCLC, Vebreltinib, Met, Overexpression
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VebreltinibDrug
vebreltinib，150mg，oral，bid
ChemotherapyDrug
Administered in accordance with the approved label
| Study group | Role | What they receive |
|---|---|---|
| vebreltinib+ platinum-based chemotherapy | Experimental | Not described Receives: Drug: Vebreltinib; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit.
Measured: up to 24 months
Secondary outcomes (4)
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
DCR
Disease Control Rate
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months
OS
Overall survival
Measured: From randomization until death (up to 24 months)
AE
Adverse event
Measured: From randomization until death (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital of Shanghai Jiao Tong University
- Investigators
- Wei Nie, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549061
- Sponsor's protocol ID
- PLB1001-GBD-01
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsao MS, Sholl L, Shiller M, Illei P, Wistuba II, Beasley MB, Schalper KA, Simmons A, Ansell P, Beruti S, Mino-Kenudson M. MET (c-Met) protein overexpression is an emerging protein biomarker in non-small cell lung cancer. NPJ Precis Oncol. 2025 Nov 20;9(1):369. doi: 10.1038/s41698-025-01144-9.
PubMed 41266553Camidge DR, Bar J, Horinouchi H, Goldman J, Moiseenko F, Filippova E, Cicin I, Ciuleanu T, Daaboul N, Liu C, Bradbury P, Moskovitz M, Katgi N, Tomasini P, Zer A, Girard N, Cuppens K, Han JY, Wu SY, Baijal S, Mansfield AS, Kuo CH, Nishino K, Lee SH, Planchard D, Baik C, Li M, Ansell P, Xia S, Bolotin E, Looman J, Ratajczak C, Lu S. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6.
PubMed 38843488Hass R, Jennek S, Yang Y, Friedrich K. c-Met expression and activity in urogenital cancers - novel aspects of signal transduction and medical implications. Cell Commun Signal. 2017 Feb 17;15(1):10. doi: 10.1186/s12964-017-0165-2.
PubMed 28212658Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
PubMed 39036382
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Vebreltinib Combined With Platinum-Doublet Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Negative Driver Genes and MET Overexpression
- ClinicalTrials.gov ID
- NCT07549061
- Acronym / sponsor ID
- PLB1001-GBD-01
- Conditions
- Lung Neoplasms
- Keywords
- NSCLC, Vebreltinib, Met, Overexpression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Apr 2026 (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.
To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.
Detailed description
This is a prospective, single-center, single-arm Phase II clinical study designed to investigate the efficacy and safety of vebreltinib combined with platinum-based chemotherapy in treatment-naïve patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.In this study, all eligible participants will provide written informed consent, and after meeting the inclusion and exclusion criteria during screening, will receive vebreltinib (150 mg orally Bid) plus platinum-doublet chemotherapy. Oral vebreltinib (150 mg Bid) will be continued until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vebreltinib+ platinum-based chemotherapy | Experimental | Drug: Vebreltinib, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily sign a written informed consent form (ICF) to participate in the study; be willing and able to comply with study-related visits and procedures.
- Male or female subjects aged 18 years or older.
- Pathologically confirmed non-small cell lung cancer (NSCLC); outside hospital pathology reports are acceptable.
- Newly diagnosed metastatic NSCLC (clinical Stage IVA or IVB) or recurrent NSCLC (staged in accordance with the AJCC Cancer Staging Manual 9th edition), not eligible for curative-intent surgery or radiotherapy.
- Treatment-naïve advanced NSCLC not amenable to curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy/chemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted if completed at least 12 months before disease recurrence.
Key exclusion criteria (25 listed)
- Spinal cord compression. Symptomatic or unstable brain metastases, unless the patient has completed curative treatment, is not receiving corticosteroid therapy, and has maintained a stable neurological status for at least 2 weeks after completion of curative treatment and steroid therapy. Patients with asymptomatic brain metastases may be included if the investigator determines there is no immediate indication for curative treatment.
- Meeting any of the following prior treatment history criteria:
- Major surgery (e.g., intrathoracic, intra-abdominal, or intrapelvic surgery) within 4 weeks prior to enrollment, or failure to recover from side effects of such surgery. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery, and patients may be enrolled 1 week after these procedures.
- Treatment with traditional Chinese medicine (TCM) or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose of study drug.
- Treatment with strong CYP3A4 inducers and/or strong inhibitors, and inability to discontinue such agents for at least 1 week prior to initiation of study treatment 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 |
|---|---|---|
| Vebreltinibvebreltinib，150mg，oral，bid | Drug | vebreltinib+ platinum-based chemotherapy |
| ChemotherapyAdministered in accordance with the approved label | Drug | vebreltinib+ platinum-based chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit.
4 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
DCR
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months
OS
Time frame: From randomization until death (up to 24 months)
AE
Time frame: From randomization until death (up to 24 months)
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 29 Apr 2026.
- Results publication: PubMed 41266553Tsao MS, Sholl L, Shiller M, Illei P, Wistuba II, Beasley MB, Schalper KA, Simmons A, Ansell P, Beruti S, Mino-Kenudson M. MET (c-Met) protein overexpression is an emerging protein biomarker in non-small cell lung cancer. NPJ Precis Oncol. 2025 Nov 20;9(1):369. doi: 10.1038/s41698-025-01144-9.
- Results publication: PubMed 38843488Camidge DR, Bar J, Horinouchi H, Goldman J, Moiseenko F, Filippova E, Cicin I, Ciuleanu T, Daaboul N, Liu C, Bradbury P, Moskovitz M, Katgi N, Tomasini P, Zer A, Girard N, Cuppens K, Han JY, Wu SY, Baijal S, Mansfield AS, Kuo CH, Nishino K, Lee SH, Planchard D, Baik C, Li M, Ansell P, Xia S, Bolotin E, Looman J, Ratajczak C, Lu S. Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial. J Clin Oncol. 2024 Sep 1;42(25):3000-3011. doi: 10.1200/JCO.24.00720. Epub 2024 Jun 6.
- Results publication: PubMed 28212658Hass R, Jennek S, Yang Y, Friedrich K. c-Met expression and activity in urogenital cancers - novel aspects of signal transduction and medical implications. Cell Commun Signal. 2017 Feb 17;15(1):10. doi: 10.1186/s12964-017-0165-2.
- Results publication: PubMed 39036382Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
- 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.
Wei Nie principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vebreltinib and Chemotherapy in people with Lung Neoplasms, run by Shanghai Chest Hospital at 1 site 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 12 inclusion and 25 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: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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 Wei Nie (021-63846590, niewei-1001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549061, which also lists 4 linked publications.
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 29 Apr 2026.