tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer

tudy on Biomarkers Using Circulating Tumor Cells When Administering Osimertinib in Patients with EGFR Mutation-positive Lung Cancer - CTC-BIOME

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000032055

Enrollment

Registered

2018-04-02

Start date

2018-04-09

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) Patients with advanced and postoperative recurrent NSCLC 2) Patients with EGFR sensitive mutation (Del 19, L858R mutation) 3) Patients with tolerance to EGFR-TKI (Gefitinib, Erlotinib, Afatinib) and EGFR T790M mutation 4) Patients with no history of prior treatment with osimertinib and other third-generation EGFR-TKIs 5) Patients who have given informed consent to participate in the study 6) Patients with ECOG performance status of 0 to 2

Exclusion criteria

Exclusion criteria: 1) Patients with complications or a history of serious lung disorder 2) Patients with intermediate or serious liver disorder 3) Patients with complications or a history of serious QT prolongation (QTc value longer than 500msec, symptom of serious arrhythmia) 4) Pregnant women, women who may possibly be pregnant, women who hope to be pregnant, lactating women and men who declined contraception 5) Patients positive for human immunodeficiency virus (HIV) 6) Patients positive for HBs antigen or hepatitis C virus (HCV RNA) 7) Other patients considered as

Design outcomes

Primary

Measure	Time frame
Correlation between BIM-gamma mRNA levels in CTC and PFS with osimertinib at baseline	—

Secondary

Measure	Time frame
1) Detection rate of mRNA and DNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR T790M, C797S, BIM-gamma, EL, L, and S) in CTC and cfDNA 2) Number of CTC extracted 3) Correlation between the expression of BIM-gamma mRNA in CTC and ORR with osimertinib 4) Correlation between the expression of mRNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA, EGFR, BIM-EL, L, and S) in CTC and PFS and ORR with osimertinib 5) Correlation between the expression of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR, BIM-gamma, EL, L, and S) in cfDNA and PFS and ORR with osimertinib 6) EGFR sensitive mutation and DNA expression of T790M in CTC and cfDNA 7) Detection rate of EGFR C797S mutation in CTC and cfDNA 8) Correlation between mRNA level of BIM-gamma in CTC and PFS of the patients with Osimertininb (during Osimertinib treatment)	—

Measure

Time frame

1) Detection rate of mRNA and DNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR T790M, C797S, BIM-gamma, EL, L, and S) in CTC and cfDNA 2) Number of CTC extracted 3) Correlation between the expression of BIM-gamma mRNA in CTC and ORR with osimertinib 4) Correlation between the expression of mRNA of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA, EGFR, BIM-EL, L, and S) in CTC and PFS and ORR with osimertinib 5) Correlation between the expression of prognostic factors (PD-L1, HER2, MET, VEGFRA, PUMA , EGFR, BIM-gamma, EL, L, and S) in cfDNA and PFS and ORR with osimertinib 6) EGFR sensitive mutation and DNA expression of T790M in CTC and cfDNA 7) Detection rate of EGFR C797S mutation in CTC and cfDNA 8) Correlation between mRNA level of BIM-gamma in CTC and PFS of the patients with Osimertininb (during Osimertinib treatment)

—

Countries

Japan

Contacts

Public ContactKazutoshi Isobe

Toho University School of Medicine Division of Respiratory Medicine

kazutoshiisobe@med.toho-u.ac.jp03-3762-4151

Outcome results