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

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0003069

Enrollment

225

Registered

2018-08-06

Start date

2018-04-23

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : arm A: Intercalating arm (Duration: 3wks x 4 cycles = 12 wks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, q3wks mainternance (Duration: 1 year) Gefitinib 250mg D1-28 a

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: 1. Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC. 2. Patients with interstitial lung disease

Design outcomes

Primary

Measure	Time frame
disease-free survival	—

Secondary

Measure	Time frame
Overall survival;safety;tolerability	—

Countries

Korea, Republic of

Contacts

Public ContactYuri Kang

Yonsei University Health System, Severance Hospital

rkddbfl@yuhs.ac+82-2-2227-8296

Outcome results