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)
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, 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);
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;
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 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;
patients with clinically poorly controlled pleural, abdominal or pericardial effusions who, in the judgment of the investigator, are not suitable for enrollment;
Single group
PLB1001
Drug200mg BID Oral
Confirmed Objective Response Rate Evaluated by IRC
Objective response rate will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective response rate is defined as the percentage of patients who experienced either a complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, but at least increase 5mm, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Confirmed Objective Response Rate evaluated by Investigator
Objective response rate will be determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Objective response rate is defined as the percentage of patients who experienced either a complete response (CR) or partial response (PR) from first administration of trial treatment to first observation of progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, but at least increase 5mm,taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Disease Control Rate evaluated by IRC and Investigator
Disease Control Rate according to RECIST 1.1 is the percentage of patients who experienced either a complete response (CR), partial response (PR) or stable disease (SD).
Duration Of Response evaluated by IRC and Investigator
Duration Of Response according to RECIST 1.1 is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause.
Time To Response evaluated by IRC and Investigator
Time To Response according to RECIST 1.1 is the time from the first trial treatment administration to the CR/PR (whichever is first) criteria are first met.
Minimum plasma concentration (Cmin) of drug and safety-analysis-set.etc
Subjects need collect PK sample within 2 hours prior to morning dose on day 1 (±7 days) of cycles 2, 3, and 5.
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