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.

January 10, 2019 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

225

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Department of Oncology, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • chemotherapy alone arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 10, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (ACTUAL)

December 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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