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.

  • STATUS
    Recruiting
  • End date
    Dec 22, 2022
  • participants needed
    225
  • sponsor
    Yonsei University
Updated on 22 January 2021

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.

Details
Condition Completely Resected NSCLC With Common EGFR Mutations
Treatment gefitinib, pemetrexed,cisplatin, Vinorelbine, cisplatin
Clinical Study IdentifierNCT03381066
SponsorYonsei University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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