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New treatment option for Non-small Cell Lung Cancer
Official title A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)
ClinicalTrials.gov ID: NCT05989542
What this study is testing
What is PLB1001?
PLB1001 is an investigational medicine, given as a pill taken by mouth, 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
- The goal of this clinical trial is to test if PLB1001 works well and safely in Non-small cell lung cancer patients with MET exon 14 mutation. The main questions it aims to answer are: If it is works well in Non-small cell lung cancer patients with MET exon 14 mutation If it is safety and tolerant in Non-small cell lung cancer patients with MET exon 14 mutation Participants will 1.
- Phase 3: a large, late-stage study
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
- voluntarily sign a written informed consent to participate in the study and be willing and able to comply with study-related visits and procedures;
- Male or female aged 18 years and above;
- patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (including sarcomatoid carcinoma of...
- The presence of MET exon 14 jump mutation was confirmed by the NGS test in the central laboratory, and the 'Combined Human 9 Gene Mutation Detection...
- Tissue sample testing confirms EGFR wild-type, ALK rearrangement negative, ROS1 rearrangement negative, and KRAS mutation negative;
You likely can't join if
- unwilling to provide tumor tissue or blood samples for molecular testing;
- previous treatment with MET inhibitors or HGF-targeted therapy;
- have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for...
- patients with clinically poorly controlled pleural, abdominal or pericardial effusions who, in the judgment of the investigator, are not suitable for...
- unstable or uncontrolled disease or conditions related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure...
- a coagulation disorder or bleeding tendency, including an arterial or venous thromboembolic event (including myocardial infarction, cerebrovascular...
See the full eligibility criteria
Who can join
- voluntarily sign a written informed consent to participate in the study and be willing and able to comply with study-related visits and procedures;
- Male or female aged 18 years and above;
- patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (including sarcomatoid carcinoma of the lung, according to the AJCC 8th edition of lung cancer staging...
- The presence of MET exon 14 jump mutation was confirmed by the NGS test in the central laboratory, and the 'Combined Human 9 Gene Mutation Detection Kit (Reversible End Termination Sequencing)' produced by Guangzhou...
- Tissue sample testing confirms EGFR wild-type, ALK rearrangement negative, ROS1 rearrangement negative, and KRAS mutation negative;
- at least one measurable lesion (per RECIST 1.1 criteria). For a lesion that has received prior radiotherapy, it may be counted as a target lesion only if definitive disease progression has occurred since radiotherapy;
- an ECOG performance status score of 0-1;
- expected survival ≥ 3 months;
- Laboratory tests that meet the following requirements:
- Aspartate aminotransferase (AST): ≤ 3 x ULN (no liver metastases)
- Alanine aminotransferase (ALT): ≤3 × ULN (no liver metastases)
- Total bilirubin (TBIL): ≤1.5 × ULN (no liver metastases)
- AST: ≤5.0 × ULN (with liver metastases)
- ALT: ≤5.0 × ULN (with liver metastasis)
- Total bilirubin: ≤3.0 × ULN (with liver metastases)
- Platelet count: ≥75 × 10⁹/L (without blood transfusion or mono-collected platelet transfusion or growth factor use within 10 days prior to the start of treatment)
- Absolute neutrophil count: ≥ 1.5 × 10⁹/L (in the absence of growth factors within 10 days prior to the start of treatment)
- Hemoglobin \> 90 g/L (in the absence of blood transfusion or use of growth factors within 10 days prior to the start of treatment)
- Coagulation index: INR≤2.0
- Creatinine clearance (Ccr) \>50 mL/min, with Ccr using the Cockcroft-Gault formula: (140 - age[yr]) × body weight (kg) × 1.23 × (0.85, if female)/serum creatinine (μmol/L)
- Urea/urea nitrogen: ≤1.5 × ULN
- Asymptomatic serum amylase ≤ grade 2 (NCI-CTCAE 5.0). For patients with Grade 2 serum amylase abnormalities prior to first dose, it is important to confirm that there are no signs and/or symptoms suggestive of...
- Serum lipase ≤ 1.5 × ULN;
- the investigator is judged to be compliant and able to complete scheduled visits, treatments and laboratory tests according to the protocol;
- men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 3 months after the last dose of study drug. Women of childbearing potential must have...
What rules you out
- unwilling to provide tumor tissue or blood samples for molecular testing;
- previous treatment with MET inhibitors or HGF-targeted therapy;
- have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control; NOTE: Patients with CNS metastases whose symptoms have been...
- patients with clinically poorly controlled pleural, abdominal or pericardial effusions who, in the judgment of the investigator, are not suitable for enrollment;
- unstable or uncontrolled disease or conditions related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure [NYHA \> Class II], unstably controlled hypertension [defined as...
- a coagulation disorder or bleeding tendency, including an arterial or venous thromboembolic event (including myocardial infarction, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep...
- The presence of risk factors for QTc interval prolongation such as chronic hypokalaemia not corrected by complementary therapies, congenital or familial long QT interval syndrome, family history of unexplained sudden...
- any significant rhythm abnormality such as complete left bundle branch block, second or third degree heart block, medically uncontrolled ventricular arrhythmias, supraventricular, nodal arrhythmias, and medically...
- active gastrointestinal disorders (e.g., ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, and malabsorption syndromes) or other conditions (e.g., inability to swallow the test medication, or prior major...
- the presence of an active infection, including but not limited to: 1) Hepatitis B (Hepatitis B Surface Antigen [HBsAg] positive and Hepatitis B Virus [HBV] DNA ≥ 500 IU/ml), Hepatitis C (positive for both anti-Hepatitis...
- known history of hypersensitivity to the active or inactive excipients of Vebreltinib, hypersensitivity to drugs with a chemical structure similar to that of Vebreltinib.
- patients being treated with warfarin or any other coumarin derivative anticoagulant, with the exception of low-dose warfarin (\< 2 mg) for the prevention of central catheter-related thrombosis;
- presence of prior antineoplastic therapy toxicity not recovered to ≤ Grade 1 (NCI-CTCAE 5.0) or baseline, except for alopecia, skin hyperpigmentation, and Grade 2 peripheral neurotoxicity
- any comorbid medical condition that may increase the risk of toxicity;
- antineoplastic and investigational drug therapy within 2 weeks or ≤ 5 drug half-lives (whichever is longer, up to a maximum of 4 weeks) prior to initiation of the first dose of Vebreltinib. If the prior therapy was a...
- chest radiotherapy to the lung field ≤ 4 weeks prior to initiating treatment with Vebreltinib or if the patient has not recovered to ≤ Grade 1 from radiotherapy-related toxicity. For all other sites (including...
- major surgery (e.g., intrathoracic, intra-abdominal, or intra-pelvic) within 4 weeks prior to initiation of treatment with Vebreltinib, brain metastasectomy may be relaxed to within 2 weeks or if the patient has not...
- another malignancy diagnosed within the last 3 years in addition to NSCLC and/or requiring treatment. Completely resected basal cell and squamous skin cancers, and completely resected carcinoma in situ of any type are...
- patients are treated with CYP3A4 potent inducer and/or potent inhibitor medications that cannot be discontinued for at least 1 week prior to initiation of treatment with Vebreltinib and for the duration of the study;
- is pregnant or is breastfeeding
- is currently participating in another treatment clinical trial or has received an investigational drug within 2 weeks prior to the first dose of the test drug
- other circumstances that, in the opinion of the investigator, make participation in the study inappropriate, such as the presence of evidence of severe or uncontrolled systemic disease, including, but not limited to...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.