Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients

Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients - Prospective observational study for re-challenge treatment with EGFR-TKI in EGFR mutated non-small cell lung cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044049

Enrollment

Registered

2021-04-27

Start date

2020-06-05

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 non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A patient with evaluable lesions by RECIST (version 1.1) 2) A patient with EGFR active mutation (at least one of the following: EGFR exon19 deletion, EGFR-Exon20 S768I mutation, EGFR exon21-L858R, L861Q mutation, exon18-G719X point mutation) 3) A patient with disease progression after osimertinib treatment

Exclusion criteria

Exclusion criteria: 1) A patient whose previous treatment with osimertinib was discontinued due to toxicity 2) A patient with no target lesions 3) A patient who have already received a first/second generation EGFR-TKI after osimertinib resistance 4) A patient who is judged ineligible to enroll the study by an attending doctor.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival: PFS	—

Secondary

Measure	Time frame
Overall survival: OS Time to treatment failure: TTF Disease control rate: DCR Depth of Response: DpR And others	—

Countries

Japan

Contacts

Public ContactTadaaki Yamada

University Hospital, Kyoto Prefectural University of Medicine Department of pulmonary medicine

m-kenji@koto.kpu-m.ac.jp075-251-5513

Outcome results