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New treatment option for Non-Small Cell Lung Cancer
Official title A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive
ClinicalTrials.gov ID: NCT06930794
What this study is testing
What is Vebreltinib combined with platinum-based doublet chemotherapy.?
Vebreltinib combined with platinum-based doublet chemotherapy. is an investigational medicine, given as a twice-daily infusion into a vein, 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 study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive. The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- male or female people ≥ 18 years of age at the time of signing ICF.
- histologically or cytologically confirmed diagnosis of non-radical, locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) non-squamous cell...
- Part 1 (introductory stage)people with MET-positive (MET amplification or MET overexpression) tumors will be enrolled. MET amplification is defined...
- Part 1 (Lead-in Period): Documented evidence confirms that the tumor tissue specimen tested negative for sensitive epidermal growth factor receptor...
- no prior systemic therapy for locally advanced or metastatic non-squamous NSCLC. Note: people are permitted to receive neoadjuvant/adjuvant therapy...
You likely can't join if
- has participated in another therapeutic clinical trial within 28 days prior to the first study dose.
- have undergone major surgery within 28 days prior to the first study dose or anticipate the need for major surgery during the study period...
- lung field or whole brain radiotherapy within 28 days prior to first study dose or palliative localized radiotherapy within 14 days prior to first...
- have received a proprietary Chinese medicine with an antitumor indication within 1 week prior to the first study dose. Has received local antitumor...
- a history of another primary malignancy diagnosed or requiring treatment within the past 3 years (with the exception of localized basal cell...
- toxicity from prior therapy that has not returned to ≤ Grade 1 or baseline levels (as assessed by NCI-CTCAE v5.0), except for alopecia, skin...
See the full eligibility criteria
Who can join
- male or female people ≥ 18 years of age at the time of signing ICF.
- histologically or cytologically confirmed diagnosis of non-radical, locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) non-squamous cell type NSCLC (refer to the American Joint Committee on Cancer [AJCC]...
- Part 1 (introductory stage)people with MET-positive (MET amplification or MET overexpression) tumors will be enrolled. MET amplification is defined as the presence of MET amplification confirmed by second-generation...
- Part 1 (Lead-in Period): Documented evidence confirms that the tumor tissue specimen tested negative for sensitive epidermal growth factor receptor (EGFR) mutations (including exon 19 deletion, exon 21 L858R or L861Q...
- no prior systemic therapy for locally advanced or metastatic non-squamous NSCLC. Note: people are permitted to receive neoadjuvant/adjuvant therapy as long as the relevant therapy has been completed for at least 6...
- at least one measurable target lesion as defined by the Response to Criteria for Evaluation of how well it works in Solid Tumors (RECIST) V1.1 criteria (see Chapter 10.4).
- ECOG PS ≤ 1.
- expected survival ≥ 12 weeks as determined by the investigator.
- good organ function as determined by medical evaluation (within 7 days prior to first study dose), including:
- Good hematologic status, defined as absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10\^9/L. No platelet transfusions within 3 days prior to the test, no red blood cell...
- Good hepatic function, defined as serum TBIL ≤ 1.5 x ULN (TBIL ≤ 3 x ULN and direct bilirubin [DBIL] ≤ 1.5 x ULN in people known to have Gilbert's syndrome), serum ALT/AST ≤ 2.5 x ULN (≤ 5.0 x ULN for people with...
- The organ function is well-determined by medical evaluation (within 7 days prior to the first study drug administration), including:
- Good renal function , defined as: creatinine clearance rate ≥50 mL/min (≥60 mL/min for those receiving cisplatin, calculated using the Cockcroft-Gault formula).
- Good coagulation function, defined as (including when receiving anticoagulation): prothrombin time (PT) \< 1.5 x ULN and activated partial thromboplastin time (APTT) \< 1.5 x ULN If people are receiving anticoagulant...
- Female people must be using adequate contraception and not breastfeeding during study participation and for 90 days after completion of study treatment; female people of childbearing potential must have had a serum...
- Reached postmenopausal status, refer to the NCCN Breast Cancer Guidelines (2024 V3.0) for a detailed definition of menopause.
- Have undergone and documented irreversible sterilization such as hysterectomy, bilateral salpingo-oophorectomy, or bilateral salpingo-oophorectomy (not tubal ligation).
- Male people of childbearing potential must use adequate contraception (e.g., barrier methods of contraception) during study participation and for 90 days after completion of study treatment. Male people must also...
- be able to provide a signed ICF that complies with the requirements and restrictions outlined in the ICF and this study protocol.
What rules you out
- has participated in another therapeutic clinical trial within 28 days prior to the first study dose.
- have undergone major surgery within 28 days prior to the first study dose or anticipate the need for major surgery during the study period. Diagnostic procedures such as thoracoscopic biopsy and mediastinoscopy may be...
- lung field or whole brain radiotherapy within 28 days prior to first study dose or palliative localized radiotherapy within 14 days prior to first study dose.
- have received a proprietary Chinese medicine with an antitumor indication within 1 week prior to the first study dose. Has received local antitumor drug therapy (e.g., thoracic or abdominal perfusion, etc.) within 14...
- a history of another primary malignancy diagnosed or requiring treatment within the past 3 years (with the exception of localized basal cell carcinoma of the skin or squamous cell carcinoma of the skin, which has been...
- toxicity from prior therapy that has not returned to ≤ Grade 1 or baseline levels (as assessed by NCI-CTCAE v5.0), except for alopecia, skin pigmentation, and any other toxicity that is assessed by the investigator to...
- presence of clinically symptomatic CNS metastases. Note: people with symptomatic CNS metastases may be enrolled in the study after they have been treated and their symptoms are controlled, have no lesion progression for...
- people with poorly controlled clinical third space effusions, including but not limited to pleural effusions, abdominal effusions, or pericardial effusions, who, in the judgment of the investigator, are not suitable for...
- presence of severe cardiovascular or cerebrovascular disease, including but not limited to:
- Mean QT interval (QTcF) corrected by the Fridericia formula from three ECG examinations at rest \> 470 ms.
- Symptomatic heart failure with a New York Heart Association (NYHA) cardiac function classification of II or higher (see Chapter 10.6).
- Echocardiographic (ECHO) assessment showing a baseline left ventricular ejection fraction (LVEF) below the lower limit of institutional normal (LLN) or \<50%.
- Any clinically significant rhythmic, conduction, or morphologic abnormality as demonstrated by resting ECG results, such as complete left bundle branch block, third-degree heart block, and ventricular arrhythmias...
- Presence of any factor that increases the risk of QTc prolongation or the risk of arrhythmia, such as heart failure, Severe hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any...
- Any of the following within 6 months prior to first study administration: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cardiomyopathy, pulmonary embolism...
- the presence of serious or uncontrolled systemic disease, as judged by the Investigator, including but not limited to:
- Uncontrolled hypertension, defined as a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite pharmacological treatment people with a history of hypertension will be allowed to enroll if their...
- Current unstable or clinically significant interstitial lung disease or interstitial pneumonia, or high risk of interstitial lung disease or interstitial pneumonia (e.g., interfering with activities of daily living or...
- Unstable or decompensated other systemic disease, deep vein thrombosis, active bleeding, etc.
- presence of uncontrolled co-infections, including but not limited to: \- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. If hepatitis B surface antigen (HBsAg) positive, HBV DNA testing should be...
- Known human immunodeficiency virus (HIV) infection or known history of acquired immunodeficiency syndrome (AIDS).
- Active Syphilis positive infection.
- Active tuberculosis infection.
- Other active infection requiring systemic therapy within 14 days prior to the first study dose.
- presence of dysphagia, or active gastrointestinal disease, or major gastrointestinal surgery that may interfere with the administration or absorption of Vebreltinib (e.g., refractory nausea/vomiting/diarrhea, ulcerative...
- hypersensitivity to Pertinib or its excipients, or history of allergic reaction to drugs with similar chemical or biological structure or analogs to Pertinib, or history of severe allergic reaction to Pemetrexed...
- have received any live attenuated vaccination within 30 days prior to the first study dose.
- known psychiatric or substance abuse disorders that may affect study compliance.
- the presence of other conditions that, in the investigator's assessment, make participation in the study inappropriate, such as participation in a study that, in the investigator's opinion, is not in the subject's best...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
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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.