Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance

Sponsor
Caicun Zhou
Study ID
NCT02930954
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Gefitinib — DRUG
    Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
  • pemetrexed or gemcitabine plus carboplatin, — DRUG
    doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeks
  • bevacizumab — DRUG
    bevacizumab 7.5mg/kg intravenously per 3 weeks

Study Details

This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of combination of gefitinib and doublet chemotherapy or antiangiogenesis in advanced non-small cell lung cancer patients with EGFR activating mutation, accompanied with Bim deletion or low activating EGFR mutation abundance.

Key Dates

First listed
Oct 12, 2016
Start date
Nov 30, 2016
Status verified
Oct 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

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

Arms

  • Active Comparator: Gefitinib single agent
    Advanced NSCLC patients with EGFR activating mutation (L858R, 19Del) received Gefitinib 250mg Qd orally until progression, intolerable toxicity or death.
  • Experimental: Gefitinib combined with chemotherapy
    Gefitinib 250mg Qd combined with pemetrexed or gemcitabine plus carboplatin: Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days, Gemcitabine (1000 mg/m² days 1,d8, intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days
  • Experimental: Gefitinib combined with antiangiogenesis
    Gefetinib 250mg Qd combined with bevacizumab 7.5mg/kg per 21 days

Primary Outcome Measure

Progression free survival [ Time Frame: 8 weeks ]

Central Contacts

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