Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT02759614
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    Bevacizumab15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle and Erlotinib orally once daily at 150mg/day
  • Erlotinib — DRUG
    Erlotinib 150mg, orally once a day

Study Details

This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).

Key Dates

First listed
May 3, 2016
Start date
Apr 1, 2016
Status verified
Jun 2018
Primary completion
Jun 1, 2018
Completion
Mar 30, 2020

Study Design

Enrollment
311 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab and Erlotinib
    Bevacizumab 15 mg/kg shall be intravenous infusion on day 1 once every 3 weeks, Erlotinib 150 mg tablets shall be administered orally every day at least one hour before or two hours after the ingestion of food.
  • Active Comparator: Erlotinib
    Erlotinib 150 mg tablets shall be administered orally every day at least one hour before or two hours after the ingestion of food.

Primary Outcome Measure

Progression-free survival (PFS) by IRC [ Time Frame: The primary PFS analysis will be performed when approximately 224 PFS events (disease progression or death, whichever occurs first) have occurred, which is estimated to occur at approximately 18 months after enrollment of the last patient. ]

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