Assessment of surrogate signaling pathways after 1st/2nd and 3rd generation EGFR-TKI treatment in advanced non-small cell lung cancer with EGFR gene mutation -multicenter, prospective observational study-

Assessment of surrogate signaling pathways after 1st/2nd and 3rd generation EGFR-TKI treatment in advanced non-small cell lung cancer with EGFR gene mutation -multicenter, prospective observational study- - IGF signal after EGFR-TKI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024762

Enrollment

Registered

2017-01-01

Start date

2017-03-03

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 with EGFR gene mutation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histlogically or cytologically confirmed non squamous non small cell lung cancer(NSCLC) 2.Unresectable and metastatic NSCLC 3.Harboring sensitive EGFR mutation(exon19 or exon21) and exon 20 T790M 4. Adequate osimertinib treatment 5. Patients who have treated with one EGFR-TKI 6. More than 20 years old 7. Performance Status (ECOG) 0-2 8. Adequate organ functions 9. No QTc prolongation (within 450msec) 10. Insulin unused diabetic(HbA1<7.0) 11. Life expectancy over 3 months 12. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Preexisting interstitial lung disease 2. Active brain metastasis 3. HBs antigen positive 4. HBs or HBc antibody positive,and HBV-D NA positive 5. HIV,HCV career 6. Previous treatment history of cytotoxic anti-cancer agents just before osimertinib 7. Active double cancer 8. In use of steroid 9. Infection using antibiotic 10. Disagree of specimen collection 11. Patients whose attending doctor consider as inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Evaluatiopn of IGF signal pathway after 3rd generation EGFR-TKI	—

Secondary

Measure	Time frame
response rate disease control rate progression free survival FGF,PFGF,HGF signal pathway Evaluatiopn of EGFR mutaiton(e.g.T790M,C797S)	—

Countries

Japan

Contacts

Public ContactMizugaki Hidenori

Hokkaido University Hospital First department of medicine

mhide@pop.med.hokudai.ac.jp011-706-5911

Outcome results