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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

Trial Eligibility

Document

Title

    <li>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.li><li>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.li>

Clinical Trial IDs

    <li>ORG STUDY ID: 4-2016-0763li><li>NCT ID: NCT03381066li>

Conditions

    <li>Completely Resected NSCLC With Common EGFR Mutationsli>

Interventions

<td>gefitinib, pemetrexed,cisplatintd><td>Intercalating armtd><td>Intercalating armtd><td>Vinorelbine, cisplatintd><td>chemotherapy alone armtd><td>chemotherapy alone armtd>
DrugSynonymsArms

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

<td>Intercalating armtd><td>Experimentaltd><td>gefitinib, pemetrexed,cisplatintd><td>
    <li>gefitinib, pemetrexed,cisplatinli>
td><td>chemotherapy alone armtd><td>Active Comparatortd><td>Vinorelbine, cisplatintd><td>
    <li>Vinorelbine, cisplatinli>
td>
NameTypeDescriptionInterventions

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
      
<td>Maximum Eligible Age:td><td>N/Atd><td>Minimum Eligible Age:td><td>20 Yearstd><td>Eligible Gender:td><td>Alltd><td>Healthy Volunteers:td><td>Notd>

Primary Outcome Measures

<td>Measure:td><td>disease-free survivaltd><td>Time Frame:td><td>5 yearstd><td>Safety Issue:td><td/><td>Description:td><td>Time from the randomization to recurrence or any cause of death.td>

Secondary Outcome Measures

<td>Measure:td><td>Overall survivaltd><td>Time Frame:td><td>5 yeartd><td>Safety Issue:td><td/><td>Description:td><td>Time from the randomization to death of any causetd>
<td>Measure:td><td>Number of participants with treatment-related adverse events as assessed by CTCAE4.0td><td>Time Frame:td><td>5 yearstd><td>Safety Issue:td><td/><td>Description:td><td/>

Details

<td>Phase:td><td>Phase 3td><td>Primary Purpose:td><td>Interventionaltd><td>Overall Status:td><td>Not yet recruitingtd><td>Lead Sponsor:td><td>Yonsei Universitytd>

Trial Keywords

    <li>NSCLCli><li>EGFRli><li>adjuvantli><li>gefitinibli><li>intercalatingli>

Last Updated

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