To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma

Sponsor
Shenzhen People's Hospital
Study ID
NCT03656393
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Gefitinib — DRUG
    Gefitinib (250 mg, orally, every day) for 56 days
  • Vinorelbine — DRUG
    Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
  • Carboplatin — DRUG
    Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks

Study Details

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.

Key Dates

Start date
Aug 31, 2018
Status verified
Aug 2018
Primary completion
Jul 31, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Gefitinib therapy group
    Patients are treated with Gefitinib (250 mg, orally, every day) for 56 days and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.
  • Active Comparator: Vinorelbine combination therapy group
    Patients are treated with vinorelbine (60 mg/m2, orally, Once every three weeks) plus carboplatin (AUC5, intravenously drip, once a week) for 6 weeks and then have an operation. If there is progress after intervention, Patients are further treated with pemetrexe (500 mg/m2, intravenously drip, once a week) plus cisplatin (75 mg/m2, iv. once a week) for 4 weeks.

Primary Outcome Measure

2y DFS [ Time Frame: 2 years ]

Central Contacts

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