Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT04575415
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
  • Erlotinib — DRUG
    Erlotinib 150mg, orally once a day
  • Gefitinib — DRUG
    Gefitinib 250mg, orally once a day
  • Icotinib — DRUG
    Icotinib 125mg three times a day
  • Afatinib — DRUG
    Afatinib 40 mg or clinical routine dose once daily
  • Dacomitinib — DRUG
    Dacomitinib 45mg or clinical routine dose once daily
  • Osimertinib — DRUG
    Osimertinib 80 mg once daily

Study Details

This study is a prospective, multicenter, real-world study to investigate the efficacy and safety of bevacizumab plus epidermal growth factor (EGFR) Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB/IV EGFR-mutant Non-small Cell Lung Cancer.

Key Dates

Start date
Oct 7, 2020
Status verified
Oct 2020
Primary completion
May 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
272 participants (estimated)

Arms

  • Arm: Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib
    Patients with EGFR-mutant NSCLC would receive bevacizumab plus first-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Erlotinib 150 mg tablets once daily or Gefitinib 250mg once daily or Icotinib 125mg three times a day would be administered.
  • Arm: Arm 2:Bevacizumab plus Afatinib/Dacomitinib
    Patients with EGFR-mutant NSCLC would receive bevacizumab plus second-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks.Afatinib 40 mg or clinical routine dose once daily or Dacomitinib 45mg or clinical routine dose once daily or clinical routine dose would be administered.
  • Arm: Arm 3:Bevacizumab plus Osimertinib
    Patients with EGFR-mutant NSCLC would receive bevacizumab plus third-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Osimertinib 80 mg tablets once daily would be administered.

Primary Outcome Measure

Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1 [ Time Frame: This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data. ]

Central Contacts

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