Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and/or Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure
Ability to understand and willingness to sign a written informed consent document.
Aged at least 18 years old.
Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
At least one measurable lesion as defined by RECIST V1.1.
There are mutations of ALK or ROS1.
Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
Before randomization, patients did not recover from any toxicity and/ or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0), except for hair loss and irrecoverable permanent radiation damage.
Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.
Parallel
Vebreltinib
DrugSubjects will receive Vebreltinib Enteric-coated Capsule orally twice per day (BID).
PLB1004
DrugSubjects will receive PLB1004 80mg orally once per day (QD).
Pemetrexed plus Carboplatin or Cisplatin
DrugSubjects randomized to the control group received pemetrexed 500 mg/m² + platinum-based chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m²) via intravenous infusion for 4-6 cycles (determined by the investigator) as initial therapy, followed by pemetrexed maintenance therapy (500 mg/m²) until disease progression, intolerable toxicity, initiation of new antitumor therapy, death, loss to follow-up, or other treatment-terminating conditions (whichever occurred first).
Progression-Free Survival (PFS) by BICR
Progression-free survival (PFS) as assessed by a Blind Independent Center Review Committee (BICR) with reference to RECIST v1.1 for Solid tumors.
Progression-Free Survival (PFS) by the investigator
Refer to RECIST v1.1, PFS assessed by the investigator.
The objective response rate of the tumor (ORR)
Refer to RECIST v1.1, ORR assessed by the investigator and BICR.
Duration of Response (DoR)
Refer to RECIST v1.1, DoR assessed by the investigator and BICR.
The disease control rate (DCR)
Refer to RECIST v1.1, DCR assessed by the investigator and BICR.
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