A phase II study of gefitinib with TRT in patients with stage III NSCLC harboring EGFR mutations

Phase 2

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCTs041180080
• Lead Sponsor: Murakami Haruyasu

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

• Study Start: 2019-03-11
• Study Completion: 2019-11-06
• Results First Posted: 2021-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1) Pathologically confirmed NSCLC
2) Treatment naive unresectable stage III disease
3) Harboring EGFR mutation
4) Age of 20 to 75 years
5) ECOG PS of 0 or 1
6) Evaluable target lesions as per RECIST ver. 1.1
7) Adequate organ function
8) Confirmed as eligible for the protocol defined radiotherapy by radiologists
9) Written informed consent

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