Survival follow up of JO25567, a randomized phase 2 study comparing erlotinib and bevacizumab combination with erlotinib alone in NSCLC patients harboring EGFR mutation.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BEVACIZUMAB
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  Patients with EGFR mutated NSCLC who completed Study JO25567: a Randomized Phase 2 Study Comparing Erlotinib and Bevacizumab Combination with Erlotinib Alone in NSCLC Patients Harboring EGFR Mutation.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  75

Study design details

• Main study objective:
  The study followed patients with EGFR mutated NSCLC who completed Study JO25567 with the aim to compare the overall survival of the patients who received bevacizumab plus erlotinib to those who were treated with Erlotinib alone.
• Outcomes:
  The primary efficacy endpoint in this study was Overall Survival, defined as the time from the date of randomization in the JO25567 study to the date of death irrespective of the cause.
• Data analysis plan:
  Overall Survival curves for each treatment group are estimated using the Kaplan-Meier product limit method. Median values of OS and survival rate, along with two-sided 95% CI, are calculated. A log-rank test was also applied to compare the distribution between groups. Associated 95% confidence interval are calculated using the Greenwood formula. Furthermore, the Cox regression analysis was applied and the hazard ratios and their 95% confidence intervals estimated. Kaplan-Meier curve were displayed and created raw output of LIFETEST procedure.