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A study to confirm the detection rate of EGFR T790M in bronchial washings of non-small cell lung cancer patients and the therapeutic effect of Lecraza® in T790M positive patients

An open label, multicenter, single arm, exploratory study to determine the detection rate of EGFR T790M from bronchial washing fluid (BWF) in patients with non-small cell lung cancer (NSCLC) who failed 1st line EGFR-tyrosine kinase inhibitor (TKI) treatment and to confirm the therapeutic efficacy of Leclaza® in the T790M-positive patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009390
Enrollment
40
Registered
2024-05-03
Start date
2024-05-06
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult males or females aged 18 years or older. 2. Patients diagnosed with locally advanced or metastatic non-small cell lung cancer. 3. Patients diagnosed with histologically or cytologically confirmed mEGFR (+) adenocarcinoma of the lung. 4. Patients who have received treatment with a first-line EGFR-TKI approved in the country. 5. Patients who have experienced recurrence while on first-line EGFR-TKI therapy after the start date of the study. 6. Patients for whom the response to first-line EGFR-TKI therapy can be evaluated. 7. Patients who have provided consent for and undergone tissue biopsy, blood sample collection, and bronchoscopy for EGFR mutation confirmation. 8. Patients who have provided written consent for participation in the study.

Exclusion criteria

Exclusion criteria: Patients who discontinued treatment with first-generation or second-generation EGFR-TKIs for reasons other than disease progression. Patients for whom medical records are not available for review. Patients who cannot undergo all tests required for selection criterion 7) due to overall health status or other reasons. Patients for whom any form of intervention for cancer treatment occurred between bronchial washing fluid and blood sample collection. Individuals who have not consented to undergo testing and provide samples.

Design outcomes

Primary

MeasureTime frame
objective response rate, ORR

Secondary

MeasureTime frame
Progression-Free Survival (PFS), Duration of Response (DoR), Time to Tumor Progression (TTP)

Countries

Korea, Republic of

Contacts

Public Contactchi young kim

Yonsei University Health System, Gangnam Severance Hospital

cykim@yuhs.ac+82-2-2019-3316

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026