Spots Global Cancer Trial Database for Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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