NCT05394233

Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC

Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed for Untreated EGFR+ and High PD-L1 Expression Non-squamous NSCLC :a Phase II, Single-center, Single Arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study

Detailed description

A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study; Research purposes: Main purpose: To evaluate the median progression-free rate of tislelizumab combined with bevacizumab and platinum pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression Survival (middle progression free survival, mPFS) Secondary purpose: * Evaluation of objective response rate (ORR) according to RECIST version 1.1; * Evaluation of disease control rate (DCR) according to RECIST version 1.1; * Assess overall survival (OS); * Assess Duration of Response (DOR); * Evaluate the safety of the treatment using NCI-CTCAE v5; Exploratory Purpose: • Assess potential predictive biomarkers.

Conditions

• Non-squamous Non-small Cell Lung Cancer
• EGFR Gene Mutation

Interventions

Type	Name	Description
DRUG	Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed	Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours, every 3 weeks, Pemetrexed, 500 mg/m2, intravenously every 3 weeks, Tislelizumab, 200 mg IV every 3 weeks

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-05-27
• Last updated: 2022-05-27

Locations

3 sites across 1 country: China