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.

Completely Resected NSCLC With Common EGFR Mutations Clinical Trial

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03381066
• Other study ID #: 4-2016-0763
• Status: Recruiting
• Phase: Phase 3
• Start date: April 10, 2018
• Est. completion date: December 2022

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Byoung Chul Cho, MD
• Phone: 82 2 2228 0880
• Email: cbc1971[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Completely Resected NSCLC With Common EGFR Mutations

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Oncology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	Time from the randomization to recurrence or any cause of death.	5 years
Secondary	Overall survival	Time from the randomization to death of any cause	5 year
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE4.0		5 years