NCT05507606

Study of Osimertinib+Bevacizumab+Chemotherapy for EGFR+ Advanced Non-Small Cell Lung Cancer With Concurrent Mutations

Phase I Study of Osimertinib+Bevacizumab+Carboplatin and Pemetrexed for Untreated Patients With EGFR Mutation Advanced Non-squamous Non-Small Cell Lung Cancer With Concomitant Mutations.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, phase I clinical trial aimed to evaluate the efficacy and safety of Osimertinib+Bevacizumab+Carboplatin and Pemetrexed for Untreated Patients With EGFR Mutation Advanced Non-squamous Non-Small Cell Lung Cancer With Concomitant Mutations.

Detailed description

Patients received Bevacizumab, 7.5mg/kg d1, Pemetrexed, 500mg/m2, d1 and Carboplatin AUC5, d1; osimertinib 80mg/d , d1-21, Q3W/cycle; induction therapy for 4 cycle, then Carboplatin was stopped after 4 cycles, and osimertinib combined with bevacizumab and pemetrexed were given for maintenance treatment every 3 weeks; Bevacizumab and pemetrexed were discontinued for 2 years; After that, the maintenance treatment of osimertinib was continued

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	osimertinib 80mg/d
DRUG	Bevacizumab Biosimilar IBI305	Bevacizumab, 7.5mg/kg d1; was discontinued after 2 years
DRUG	Carboplatin	Carboplatin AUC5, d1; was stopped after 4 cycles
DRUG	Pemetrexed	Pemetrexed, 500mg/m2, d1;Q3W/cycle; was discontinued after 2 years

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2022-08-19
• Last updated: 2022-08-19

Locations

1 site across 1 country: China