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.
NCT ID: NCT03381066
Last Updated: 2019-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
225 participants
INTERVENTIONAL
2018-04-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intercalating arm
gefitinib, pemetrexed,cisplatin
gefitinib, pemetrexed,cisplatin
* 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
chemotherapy alone arm
Vinorelbine, cisplatin
Vinorelbine, cisplatin
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
Interventions
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gefitinib, pemetrexed,cisplatin
* 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
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Tumors with common EGFR mutations (19del or L858R)
3. Adequate oran function
Exclusion Criteria
2. Patients with interstitial lung disease
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Oncology, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2016-0763
Identifier Type: -
Identifier Source: org_study_id
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