Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer

Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer - Prospective observational study on the key drug selection in advanced/recurrent EGFR mutation-positive non-small-cell lung cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028989

Enrollment

600

Registered

2017-09-10

Start date

2017-10-01

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

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: I. Patients with histologically or cytologically confirmed EGFR mutation-positive advanced/recurrent non-Sq NSCLC (including minor mutation) II. Patients who received or are planning to receive any drug therapy for NSCLC after 01 June 2016. (Data are collected from the patients who actually received drug therapy after 01 June 2016.) III. Sufficient functions of the main organs IV. PS 0-2 at the start of initial drug therapy

Exclusion criteria

Exclusion criteria: Patients judged by the investigator to be unsuitable for the study

Design outcomes

Primary

Measure	Time frame
To reveal real world clinical utility of Osimertinib in EGFR-mutant non-Sq NSCLC 1)Frequency of Osimertinib utilization after 1st or 2nd generation EGFR-TKI 2)Line of Osimertinib administration 3)Efficacy of Osimertinib 4)Toxicities of Osimertinib	—

Secondary

Measure	Time frame
1)To reveal real world treatments and their results for EGFR-mutant non-Sq NSCLC 2)To reveal the factors contributing to OS prolongation 3)Osimertinib-related part: 1.Frequency and success rate of re-biopsy 2.Efficacy of Osimertinib in CNS 3.Pattern, frequency, and severity of interstitial pneumonitis (IP) by Osimertinib 4)Osimertinib-unrelated part 1.Line of Nivolumab (and the other ICI monotherapy) administration 2.Response rate, disease control rate, and PFS of Nivolumab (and the other ICI monotherapy) in EGFR-mutated NSCLC 3.Accumulation and analysis of the cases who received an EGFR-TKI after ICIs. 5)To reveal interactions among different treatments especially that with ICI	—

Measure

Time frame

1)To reveal real world treatments and their results for EGFR-mutant non-Sq NSCLC 2)To reveal the factors contributing to OS prolongation 3)Osimertinib-related part: 1.Frequency and success rate of re-biopsy 2.Efficacy of Osimertinib in CNS 3.Pattern, frequency, and severity of interstitial pneumonitis (IP) by Osimertinib 4)Osimertinib-unrelated part 1.Line of Nivolumab (and the other ICI monotherapy) administration 2.Response rate, disease control rate, and PFS of Nivolumab (and the other ICI monotherapy) in EGFR-mutated NSCLC 3.Accumulation and analysis of the cases who received an EGFR-TKI after ICIs. 5)To reveal interactions among different treatments especially that with ICI

—

Countries

Japan

Contacts

Public ContactFumio Imamura

Osaka International Cancer Institute Department of Thoracic Oncology

imamura-fu@mc.pref.osaka.jp+81-6-6945-1181

Outcome results