drugset / Trial / NCT05266846

Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK

NCT05266846 ↗

Phase 2 Recruiting 78 enrolled Hunan Province Tumor Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5'ALK. The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5'ALK Failed from first line Alectinib. The patients should meet the physical requirements to receive Pembrolizumab, Bevacizumab with Chemotherapy. All the patients who meet these requirements will be enrolled in this study. The eligible patients will be treated with Pembrolizumab 200 mg intravenously (IV) plus Bevacizumab 15mg/kg+ Pemetrexed 500mg/m2+Carboplatin AUC=4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W+ Bevacizumab 15mg/kg+Pemetrexed 500mg/m2 for up to 31cycles or until disease progression, intolerable toxicity, or physician or participant decision.

Timeline

Start
2024-05-29
Primary completion
2026-11-16
Completion
2027-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 20 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Cisplatin Other / unclassified — Intravenous
Background Pembrolizumab injection Unknown 500 mg/m2 Intravenous

Indications