💬In plain words
What the trial is, and whether it could suit you
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. be given PLB1001 200mg BID,oral.
2. be received hematology and urine and ECG examinations every 14 days (First 3 months) or every 28 days (After 3 months)
3. be received Image examination every 8 weeks(First year) or every 12 weeks(After one year)
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. voluntarily sign a written informed consent to participate in the study and be willing and able to comply with study-related visits and procedures;
2. Male or female aged 18 years and above;
3. 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, Stage IIIB - Stage IV) (non-site pathology reports are acceptable);Patients have not received any prior systemic antineoplastic drug therapy for advanced diseaseor disease progression or toxicity intolerance after prior systemic therapy (≤3 lines);
4. 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 Burning Stone Medical Laboratory Ltd. will be used for the testing and analysis of the samples in the central laboratory. Patients are required to provide sufficient blood samples for retrospective analysis by the central laboratory ('Human Circulating Tumour DNA Multi-Gene Mutation Test Kit (Reversible End Termination Sequencing Method)' manufactured by Guangzhou Burnstone Medical Laboratory Co. Ltd. to support the development of blood companion diagnostic reagents required for the marketing of Piratinib. Note: For patients who have received previous systemic anti-tumour therapy, tumour tissue obtained after disease progression on the most recent anti-tumour therapy will be preferred for biomarker testing;
5. Tissue sample testing confirms EGFR wild-type, ALK rearrangement negative, ROS1 rearrangement negative, and KRAS mutation negative;
6. 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;
7. an ECOG performance status score of 0-1;
8. expected survival ≥ 3 months;
9. 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 pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging results, etc.)
* Serum lipase ≤ 1.5 × ULN;
10. the investigator is judged to be compliant and able to complete scheduled visits, treatments and laboratory tests according to the protocol;
11. 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 a negative serum pregnancy test within 7 days prior to the first dose of study drug.
Exclusion Criteria:
1. unwilling to provide tumor tissue or blood samples for molecular testing;
2. previous treatment with MET inhibitors or HGF-targeted therapy;
3. 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 controlled may be enrolled in this trial. Patients with symptomatic or unstable CNS metastases must have completed radiotherapy, or at least 2 weeks after surgical treatment of CNS tumor metastases, prior to study entry. Patients must have stable neurologic function with no new neurologic deficits identified on clinical examination and no new problems identified on CNS imaging. If the patient requires steroids for the treatment of CNS metastases, they must have been stabilized on a therapeutic dose of steroids for at least 2 weeks prior to signing the informed consent form;
4. patients with clinically poorly controlled pleural, abdominal or pericardial effusions who, in the judgment of the investigator, are not suitable for enrollment;
5. 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 \[defined as diastolic blood pressure \> 100 mmHg and/or systolic blood pressure \> 160 mmHg regardless of antihypertensive medications. initiation of antihypertensive medications or adjustment of antihypertensive medications prior to Screening is permitted\]);
6. 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 vein thrombosis, or any other history of severe thromboembolism) within 6 months prior to the administration of the first study medication, any life-threatening bleeding event (including the need for transfusional therapy, surgical or topical