Back to resultsA 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.
Primary Purpose
Completely Resected NSCLC With Common EGFR Mutations
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
gefitinib, pemetrexed,cisplatin
Vinorelbine, cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Completely Resected NSCLC With Common EGFR Mutations focused on measuring NSCLC, EGFR, adjuvant, gefitinib, intercalating
Eligibility Criteria
Inclusion Criteria:
- Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
- Tumors with common EGFR mutations (19del or L858R)
- Adequate oran function
Exclusion Criteria:
- Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- Patients with interstitial lung disease
Sites / Locations
- Department of Oncology, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intercalating arm
chemotherapy alone arm
Arm Description
gefitinib, pemetrexed,cisplatin
Vinorelbine, cisplatin
Outcomes
Primary Outcome Measures
disease-free survival
Time from the randomization to recurrence or any cause of death.
Secondary Outcome Measures
Overall survival
Time from the randomization to death of any cause
Number of participants with treatment-related adverse events as assessed by CTCAE4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03381066
Brief Title
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.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Completely Resected NSCLC With Common EGFR Mutations
Keywords
NSCLC, EGFR, adjuvant, gefitinib, intercalating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intercalating arm
Arm Type
Experimental
Arm Description
gefitinib, pemetrexed,cisplatin
Arm Title
chemotherapy alone arm
Arm Type
Active Comparator
Arm Description
Vinorelbine, cisplatin
Intervention Type
Drug
Intervention Name(s)
gefitinib, pemetrexed,cisplatin
Other Intervention Name(s)
Intercalating arm
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vinorelbine, cisplatin
Other Intervention Name(s)
chemotherapy alone arm
Intervention Description
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
Primary Outcome Measure Information:
Title
disease-free survival
Description
Time from the randomization to recurrence or any cause of death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from the randomization to death of any cause
Time Frame
5 year
Title
Number of participants with treatment-related adverse events as assessed by CTCAE4.0
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
Tumors with common EGFR mutations (19del or L858R)
Adequate oran function
Exclusion Criteria:
Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
Patients with interstitial lung disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byoung Chul Cho, MD
Phone
82 2 2228 0880
Email
cbc1971@yuhs.ac
Facility Information:
Facility Name
Department of Oncology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoung Chul Cho, MD
Phone
82 2 2228 0880
Email
cbc1971@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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.
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