Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer - Observational study to investigate the execution rate of re-biopsy and the concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples in EGFR-TKI-resistant patients with EGFR mutation-positive advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026019

Enrollment

100

Registered

2017-02-07

Start date

2017-02-08

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: Primary registration: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Stage III/IV not amenable to definitive radiation therapy or postoperative recurrence at the start of EGFR-TKI therapy 3) Presence of any EGFR-activating mutation (Exon 19 del, L858R, or uncommon mutation) confirmed by tissue or cell genetic testing before the start of EGFR-TKI therapy 4) Ongoing EGFR-TKI (gefitinib, erlotinib, afatinib) therapy 5) No T790M mutation detected after the start of EGFR-TKI therapy 6) Written informed consent for study participation from the patient Secondary registration: 1) Sustained response to EGFR-TKI (CR, PR, or SD for>6 weeks) 2) Confirmed (or concerned about) development of resistance to EGFR-TKI In this study, development of resistance is defined as any of the three conditions below and determined by the treating physician according to the patient's condition: (i) PD assessed by RECIST (ii) PD assessed clinically (iii) SD assessed by RECIST with an increasing tendency of the tumor compared with baseline

Exclusion criteria

Exclusion criteria: Treatment by 3rd generation EGFR-TKI

Design outcomes

Primary

Measure	Time frame
Execution rate of re-biopsy in secondarily registered patients Concordance rate for T790M mutation detection by the Cobas test between histological and cytological samples.	—

Secondary

Measure	Time frame
Success rate of re-biopsy (= Number of patients with detected cancer cells / Number of re-biopsies performed), Individual test modalities (for bronchoscopy, confirm whether EBUS-TBNA or EBUS-GS has been performed or not) / Positive T790M mutation rate by biopsy site (= Number of patients with positive T790M mutation / Number of patients with detected cancer cells), Safety of individual test modalities, Analysis of reasons for patients not undergoing re-biopsy after secondary registration, Execution rate of re-biopsy by use or non-use of each test modality (e.g., EBUS-TBNA, EBUS-GS, CT-guided biopsy), Investigation of prognosis at 1 year after secondary registration (including the type of subsequent treatment)	—

Measure

Time frame

Success rate of re-biopsy (= Number of patients with detected cancer cells / Number of re-biopsies performed), Individual test modalities (for bronchoscopy, confirm whether EBUS-TBNA or EBUS-GS has been performed or not) / Positive T790M mutation rate by biopsy site (= Number of patients with positive T790M mutation / Number of patients with detected cancer cells), Safety of individual test modalities, Analysis of reasons for patients not undergoing re-biopsy after secondary registration, Execution rate of re-biopsy by use or non-use of each test modality (e.g., EBUS-TBNA, EBUS-GS, CT-guided biopsy), Investigation of prognosis at 1 year after secondary registration (including the type of subsequent treatment)

—

Countries

Japan

Contacts

Public ContactKenichi Koyama

Niigata cancer center hospital Department of internal medicine

k-koyama@niigata-cc.jp025-266-5111

Outcome results