CRETE

Osimertinib Rechallenge after Osimertinib-Associated Interstitial Lung Disease in EGFR-Mutated Advanced Non-Small Cell Lung Cancer: A Retrospective Cohort Study (CRETE)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030240645

Enrollment

100

Registered

2025-01-29

Start date

2025-04-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The proportion of patients rechallenged after ILD.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan, Korea, Taiwan

Contacts

Public ContactSeigo Katakura

Kanagawa Cancer Center

katakura.1360n@kanagawa-pho.jp+81-45-520-2222

Outcome results