NCT04988607

Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC

The Efficacy and Safety of Osimertinib Plus Bevacizumab Versus Osimertinib Monotherapy in Treatment-naïve Advanced NSCLC Patients Harbouring EGFR Exon 21 L858R Mutation: A Prospective, Multicenter, Randomized, Open Label Study (FLAIR)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, open label study to investigate the efficacy and safety of osimertinib plus bevacizumab versus osimertinib montherapy in treatment-naïve recurrent or metastatic NSCLC patients harbouring EGFR exon 21 L858R mutation.

Detailed description

Enrolled patients will be randomized 1:1, the experimental arm is osimertinib plus bevacizumab, while the control arm is osimertinib monotherapy. Osimertinib monotherapy arm is dosed at a 80 mg once per day; osimertinib plus bevacizumab arm is dosed at osimertinib 80 mg orally once every day combined with bevacizumab 15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle. All treatment will be done continuously until RECIST 1.1-defined progression as assessed by the Investigator or another discontinuation criterion is met. Patients will undergo the efficacy assessments based on RECIST 1.1 assessment criterion every 6 weeks, until disease progression as assessed by the Investigator. The follow-up assessment after disease progression will be repeated every 12 weeks until study complete. In addition, patients will undergo the safety assessment in the whole treatment period and 28-day safety follow-up after discontinued study drug for any reason or study complete.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	osimertinib plus bevacizumab arm is dosed at osimertinib 80 mg orally once every day combined with bevacizumab 15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle
DRUG	Bevacizumab	osimertinib plus bevacizumab arm is dosed at osimertinib 80 mg orally once every day combined with bevacizumab 15mg/kg by intravenous drip infusion on day 1 of a
DRUG	Osimertinib	Osimertinib is dosed orally at 80 mg once per day

Timeline

• Start date: 2021-08-01
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2021-08-03
• Last updated: 2021-08-03

Locations

1 site across 1 country: China