At a glance
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An Open-label, Randomized, Controlled, Multicenter Phase IIIb Clinical Study to Evaluate the Efficacy and Safety of Vebreltinib Enteric Capsule Combined With Platinum-based Doublet Chemotherapy Compared With Platinum-based Doublet Chemotherapy in Subjects With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Not Received Previous Systemic Treatment and MET-Positive
In Brief
A Phase 3 clinical trial evaluating Vebreltinib combined with platinum-based doublet chemotherapy. and platinum-based doublet chemotherapy. for Non-Small Cell Lung Cancer. Currently recruiting, targeting 300 participants across 2 sites.
Detailed Summary
This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive. The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression). This study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4. This study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).
Study Details
Timeline
Interventions
Vebreltinib: Each cycle is 3 weeks (21 days). It is administered orally twice a day (BID), and the dosage level depends on the cohort assignment. Platinum-based doublet chemotherapy: Each cycle is 3 weeks (21 days), and it is administered once on the first day (D1) of each cycle. Pemetrexed at a dose of 500 mg/m² plus a platinum agent (carboplatin with an area under the curve (AUC) of 5 or cisplatin at a dose of 75 mg/m²) is given by intravenous infusion for 4 to 6 cycles as the initial treatment. After that, it is switched to pemetrexed (500 mg/m²) given by intravenous infusion as the maintenance treatment.
Platinum-based doublet chemotherapy: Each cycle is 3 weeks (21 days), and it is administered once on the first day (D1) of each cycle. Pemetrexed at a dose of 500 mg/m² plus a platinum agent (carboplatin with an area under the curve (AUC) of 5 or cisplatin at a dose of 75 mg/m²) is given by intravenous infusion for 4 to 6 cycles as the initial treatment. After that, it is switched to pemetrexed (500 mg/m²) given by intravenous infusion as the maintenance treatment.