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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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ClinicalTrials.gov Identifier: NCT03381066
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Completely Resected NSCLC With Common EGFR Mutations Drug: gefitinib, pemetrexed,cisplatin Drug: Vinorelbine, cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intercalating arm
gefitinib, pemetrexed,cisplatin
Drug: 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
Other Name: Intercalating arm

Active Comparator: chemotherapy alone arm
Vinorelbine, cisplatin
Drug: Vinorelbine, cisplatin
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
Other Name: chemotherapy alone arm




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]
    Time from the randomization to recurrence or any cause of death.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 year ]
    Time from the randomization to death of any cause

  2. Number of participants with treatment-related adverse events as assessed by CTCAE4.0 [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Tumors with common EGFR mutations (19del or L858R)
  3. Adequate oran function

Exclusion Criteria:

  1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
  2. Patients with interstitial lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381066


Contacts
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Contact: Byoung Chul Cho, MD 82 2 2228 0880 cbc1971@yuhs.ac

Locations
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Korea, Republic of
Department of Oncology, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Byoung Chul Cho, MD    82 2 2228 0880    cbc1971@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03381066    
Other Study ID Numbers: 4-2016-0763
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
NSCLC
EGFR
adjuvant
gefitinib
intercalating
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Pemetrexed
Vinorelbine
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Protein Kinase Inhibitors