An Open, Multi-center, Single-arm Phase IIIb Confirmatory Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vebreltinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Exon 14 Mutation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

• 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 pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging results, etc.)

⁃ 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 a negative serum pregnancy test within 7 days prior to the first dose of study drug.

Locations
Other Locations
China
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Weizhe Xue, Ph.D
xueweizhe@pearlbio.cn
+86-10-84148931
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 136
Treatments
Experimental: PLB1001
Subjects will receive 200mg of PLB1001 twice daily in cycles of 28-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Sponsors
Leads: Beijing Pearl Biotechnology Limited Liability Company

This content was sourced from clinicaltrials.gov

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