Exploratory study of immunologic factors in re-biopsy specimen, peritumoral bronchoalveolar lavage fluid (BALF), and the peripheral blood for predicting response to the third generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) Osimertinib on non-small cell lung cancer patients with resistance to the first generation or the second generation EGFR-TKI

Exploratory study of immunologic factors in re-biopsy specimen, peritumoral bronchoalveolar lavage fluid (BALF), and the peripheral blood for predicting response to the third generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) Osimertinib on non-small cell lung cancer patients with resistance to the first generation or the second generation EGFR-TKI - Study of immunologic factor in re-biopsy specimen, peritumoral BALF, and the peripheral blood for predicting response to Osimertinib on NSCLC patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023853

Enrollment

Registered

2016-09-01

Start date

2016-09-01

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: 1 Patient with histologically or cytologic ally proven NSCLC 2 EGFR mutation including exon 19 deletion or L858R 3 Resistance to 1st or 2nd generation EGFR -TKI 4 Under consideration of Osmertinib treatment 5 Measurable lesion 6 Performance Status (ECOG scale) 0-2 7 Good main organ functions 8 Written informed consent

Exclusion criteria

Exclusion criteria: 1 Drug induced pneumonitis or lung fibrosis 2 Past interstitial pneumonitis 3 Synchronous or metachronous cancer 4 Inappropriate patient

Design outcomes

Primary

Measure	Time frame
The relationship between response to Osimertinib and a lymphocyte profile in serum, plasma or BALF, and the gene profile in tumor specimen	—

Secondary

Measure	Time frame
The relationship between response to anti-cancer agent except Osimertinib and a lymphocyte profile in serum, plasma or BALF, and the gene profile in tumor specimen	—

Countries

Japan

Contacts

Public ContactTomonori Hirashima

Osaka Habikino Medical Center Thoracic Oncology

hirashimat@ra.opho.jp072-957-2121

Outcome results