CRETE

JRCT ID: jRCT1030240645

Registered date:29/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: EGFR-Mutated Advanced Non-Small Cell Lung Cancer
• Date of first enrollment: 16/03/2025
• Target sample size: 100
• Countries of recruitment: Korea,Japan,Taiwan,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The proportion of patients rechallenged after ILD.
• Secondary Outcome: Include patient characteristics (including, age, sex, ECOG score, time between osimertinib initiation and initial ILD diagnosis, initial ILD grade and treatment, time between initial ILD diagnosis and rechallenge, recurrence of ILD, etc.) by rechallenge status, patient characteristics (including, age, sex, ECOG score, time between osimertinib initiation and initial ILD diagnosis, initial ILD grade and treatment, time between ILD diagnosis and rechallenge, etc.) by rechallenge success (i.e. whether or not ILD recurred after rechallenge), and time-to-treatment discontinuation and subsequent treatment patterns by rechallenge status.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Aged 18 years or older at the time of advanced NSCLC diagnosis. Country-specific age cut-offs may be used where necessary
- Confirmed diagnosis of stage IIIB/IIIC/IV NSCLC with tumor harboring Exon 19 deletion or L858R with or without other co-occurring EGFR mutations
- Treated with osimertinib (any line) from 1 January 2018 to 31 December 2023
- Diagnosed with radiologically or clinically verified ILD after osimertinib initiation and interrupted or discontinued osimertinib

• Exclude criteria: - Evidence of other coexisting cancer diagnoses, except nonmelanoma skin cancer and cervical carcinoma in situ

Related Information

• Primary Sponsor: Kato Terufumi