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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.

NCT03381066

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03381066

Trial Eligibility

Document

Title

  • 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.

Clinical Trial IDs

  • ORG STUDY ID: 4-2016-0763
  • NCT ID: NCT03381066

Conditions

  • Completely Resected NSCLC With Common EGFR Mutations

Interventions

DrugSynonymsArms
gefitinib, pemetrexed,cisplatinIntercalating armIntercalating arm
Vinorelbine, cisplatinchemotherapy alone armchemotherapy alone arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intercalating armExperimentalgefitinib, pemetrexed,cisplatin
  • gefitinib, pemetrexed,cisplatin
chemotherapy alone armActive ComparatorVinorelbine, cisplatin
  • Vinorelbine, cisplatin

Eligibility 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
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:disease-free survival
Time Frame:5 years
Safety Issue:
Description:Time from the randomization to recurrence or any cause of death.

Secondary Outcome Measures

Measure:Overall survival
Time Frame:5 year
Safety Issue:
Description:Time from the randomization to death of any cause
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE4.0
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yonsei University

Trial Keywords

  • NSCLC
  • EGFR
  • adjuvant
  • gefitinib
  • intercalating

Last Updated

January 11, 2019