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 | Unknown Phase 3

• 1 other identifier: 4-2016-0763
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Completely Resected NSCLC With Common EGFR Mutations

Keywords

NSCLC; EGFR; adjuvant; gefitinib; intercalating

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  Time from the randomization to recurrence or any cause of death.

  5 years

Secondary Outcomes (2)

• Overall survival

  5 year

• Number of participants with treatment-related adverse events as assessed by CTCAE4.0

  5 years

Study Arms (2)

Intercalating arm

EXPERIMENTAL

gefitinib, pemetrexed,cisplatin

Drug: gefitinib, pemetrexed,cisplatin

chemotherapy alone arm

ACTIVE COMPARATOR

Vinorelbine, cisplatin

Drug: Vinorelbine, cisplatin

Interventions

gefitinib, pemetrexed,cisplatin DRUG

* 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

Also known as: Intercalating arm

Intercalating arm

Vinorelbine, cisplatin DRUG

Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week

Also known as: chemotherapy alone arm

chemotherapy alone arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Oncology, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Interventions

Gefitinib; Pemetrexed; Cisplatin; Vinorelbine

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Central Study Contacts

Byoung Chul Cho, MD

CONTACT

82 2 2228 0880; cbc1971@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 21, 2017
• Study Start: April 10, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

KR (1)