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

JRCT ID: jRCTs041180080

Registered date:11/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-Small Cell Lung Cancer
• Date of first enrollment: 24/01/2013
• Target sample size: 27
• Study type: Interventional
• Intervention(s): An oral dose of 250mg of gefitinib is administered daily beginning on day 1, with once-daily thoracic radiotherapy delivered at 2 Gy per day to a total dose of 64 Gy.

Outcome(s)

• Primary Outcome: Progression free survival rate at 2 years.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Murakami Haruyasu
• Secondary Sponsor: Akamatsu Hiroaki
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): UMIN000008366