A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations.

Phase 2

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-UMIN000008366
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Among unresectable locally-advanced NSCLC patients with EGFR mutation, gefitinib with concurrent thoracic radiotherapy showed manageable safety profiles, but did not improve PFS rate at 2 years.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-06
• Study Completion: 2020-08-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

1) Harboring exon 20 T790M mutation. 2) Incapable of oral intake 3) With intestinal paralysis, or ileus 4) Chronic diarrhea 5)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 6) Active infection 7) Positive for HBs antigen 8) Uncontrolled diabetes mellitus 9) Severe heart disease 10) Systemic treatment with steroids 11) Concomitant cancers within 5 years 12) Prior history of thoracic radiotherapy 13) History of sereous drug allegies 14) Pregnancy, breast feeding, or hesitation in contraception 15) Other conditions not suitable for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival rate at 2 years.

Secondary Outcome Measures

Name	Time	Method
Overall response rate, progression free survival rate at 1 year, progression free survival, survival rate at 1 year, survival rate at 2 years, overall survival, and safety.