A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

Sponsor
Yonsei University
Study ID
NCT03381066
Phase
PHASE3
Status
Unknown

Conditions

  • Completely Resected NSCLC With Common EGFR Mutations

Eligibility Criteria

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

Interventions

  • gefitinib, pemetrexed,cisplatin — DRUG
    * Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week * Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2
  • Vinorelbine, cisplatin — DRUG
    Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week

Study Details

This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.

Key Dates

Start date
Apr 10, 2018
Status verified
Jan 2019
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

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

Arms

  • Experimental: Intercalating arm
    gefitinib, pemetrexed,cisplatin
  • Active Comparator: chemotherapy alone arm
    Vinorelbine, cisplatin

Primary Outcome Measure

disease-free survival [ Time Frame: 5 years ]

Central Contacts