NCT04405674

Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in TKI-Resistant EGFR-Mutated Non-squamous NSCLC

A Phase II Two Cohorts Prospective Study to Evaluate the Efficacy and Safety of Tislelizumab Combined With Chemotherapy With or Without Bevacizumab in Non-squamous NSCLC With EGFR Sensitizing Mutation Who Failed EGFR TKI Therapy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase II, open-label, multicenter, two cohorts, prospective clinical study to investigate the efficacy and safety of tislelizumab (anti-pd1 antibody) combined with chemotherapy with or without bevacizumab in non-squamous non-small cell lung cancer patients with EGFR sensitizing mutation who failed EGFR TKI (Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor) therapy.

Detailed description

Although EGFR tyrosine kinase inhibitors (TKI) have improved the survival of EGFR mutated NSCLC pts, drug resistance inevitably develops in almost all pts. Tislelizumab (tis), an anti-PD-1 mAb, has shown improved efficacy when combined with chemotherapy in pts with advanced EGFR-wt NSCLC with a tolerable safety profile. This study aims to evaluate the efficacy and safety of tislelizumab plus carboplatin and Nab-paclitaxel（cohort 1）or tislelizumab plus Nab-paclitaxel and bevacizumab （cohort 2） in EGFR-mut nsq-NSCLC pts failed to EGFR TKI therapies.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
DRUG	Carboplatin	Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
DRUG	Pemetrexed	Pemetrexed 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
DRUG	Bevacizumab	Bevacizumab 7.5mg/kg administered intravenously (IV) on Day 1 of each 21-day cycle
DRUG	Nab paclitaxel	Nab-paclitaxel 260mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles

Timeline

• Start date: 2020-07-15
• Primary completion: 2022-04-01
• Completion: 2025-03-01
• First posted: 2020-05-28
• Last updated: 2021-11-22

Locations

1 site across 1 country: China