Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT04988607
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    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
  • Bevacizumab — DRUG
    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
  • Osimertinib — DRUG
    Osimertinib is dosed orally at 80 mg once per day

Study Details

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.

Key Dates

Start date
Aug 31, 2021
Status verified
Apr 2021
Primary completion
Nov 30, 2024
Completion
May 31, 2025

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: osimertinib plus bevacizumab
    Osimertinib 80 mg (QD) in combination with Bevacizumab (15 mg/kg) (Q3W)
  • Active Comparator: osimertinib
    All patients randomized into this will only receive Osimertinib 80mg (QD)

Primary Outcome Measure

To assess the efficacy of osimertinib plus bevacizumab treatment compared with osimertinib monotherapy [ Time Frame: up to 3 years after the first patient is randomized ]

Central Contacts

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