Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT03267654
Phase
PHASE2
Status
Unknown

Conditions

  • Non-small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • gefitinib combined with chemotherapy — DRUG
    Gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours until disease progression, intolerable toxicity or patient withdraw ICF. Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days. Every 3 weeks is a chemotherapy cycle, and 4 chemotherapy cycles is maximum limit.
  • gefitinib combined with apatinib — DRUG
    gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours. Apatinib 250mg, p.o., q.d. per 21 days. until disease progression, intolerable toxicity, patient withdraw ICF or death.
  • gefitinib single agent — DRUG
    Patients received Gefitinib 250mg q.d. orally until disease progression, intolerable toxicity or death.

Study Details

This is an open-label, multicenter, randomized, phase II clinical trial, which aims to evaluate the effectiveness and safety of gefitinib versus combination of gefitinib and doublet chemotherapy or apatinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) activating mutation (exon 19 deletion or exon 21 L858R point mutation), accompanied with Bim deletion or low activating EGFR mutation abundance.

Key Dates

Start date
Oct 12, 2017
Status verified
Jul 2020
Primary completion
Oct 20, 2020
Completion
Dec 30, 2021

Study Design

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

Arms

  • Experimental: gefitinib combined with chemotherapy
    gefitinib 250mg Qd combined with pemetrexed plus carboplatin: pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days.
  • Experimental: gefitinib combined with apatinib
    gefitinib 250mg Qd combined with apatinib 250mg per 21 days
  • 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.

Primary Outcome Measure

Progression free survival [ Time Frame: 8 weeks ]

Central Contacts

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