Observational study of treatment of epidermal growth factor receptor activating mutation positive(EGFRm+)advanced or recurrent non-small-cell lung cancer

Observational study of treatment of epidermal growth factor receptor activating mutation positive(EGFRm+)advanced or recurrent non-small-cell lung cancer - CSPOR-LC02

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010538

Enrollment

500

Registered

2013-04-19

Start date

2013-04-19

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

Advanced lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with advanced or recurrent NSCLC 2.Patients with activating EGRF mutation-positive (EGFRm+)tumor 3.Patients for whom treatment with EGFR-TKI (iressa or tarceva)was started as first-line systemic treatment from January1, 2009 to December 2011

Exclusion criteria

Exclusion criteria: 1.History of platinum-based adjuvant chemotherapy 2.Presence of other active malignancy

Design outcomes

Primary

Measure	Time frame
The time from RECIST-based PD to clinical PD with EGFR-TKI.	—

Secondary

Measure	Time frame
1.Proportion of patients to whom EGFR-TKI was continued after radiological PD was judged according to RECIST to EGFR-TKI 1)with or without concomitant therapy 2)with concomitantly administered radiotherapy, surgery or chemotherapy 2.Propotion of patients in which flare developed after discontinuation of EGFR-TKI 3.Pattern of failure at the time of judgment as RECIST-based PD 4.Whole duration of treatment with EGFR-TKI 5.Survival after discontinuation of treatment with EGFR-TKI 6.Survival after RECIST-based PD to EGFR-TKI therapy was judged 7.Survival after clinical PD to EGFR-TKI therapy was judged 8.Reason of discontinuation of EGFR-TKI 9.Overall survival time	—

Measure

Time frame

1.Proportion of patients to whom EGFR-TKI was continued after radiological PD was judged according to RECIST to EGFR-TKI 1)with or without concomitant therapy 2)with concomitantly administered radiotherapy, surgery or chemotherapy 2.Propotion of patients in which flare developed after discontinuation of EGFR-TKI 3.Pattern of failure at the time of judgment as RECIST-based PD 4.Whole duration of treatment with EGFR-TKI 5.Survival after discontinuation of treatment with EGFR-TKI 6.Survival after RECIST-based PD to EGFR-TKI therapy was judged 7.Survival after clinical PD to EGFR-TKI therapy was judged 8.Reason of discontinuation of EGFR-TKI 9.Overall survival time

—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Oncology Research

info@csp.or.jp03-5287-2633

Outcome results