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TAPIOCA: The frequency of T790M Alleles and their Prognostic sIgnificance during the follow-On treatment in EGFR M+ NSCLC patients who were treated with Afatinib and gefitinib

TAPIOCA: The frequency of T790M Alleles and their Prognostic sIgnificance during the follow-On treatment in EGFR M+ NSCLC patients who were treated with Afatinib and gefitinib

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008468
Enrollment
200
Registered
2023-05-25
Start date
2023-02-21
Completion date
Unknown
Last updated
2023-05-30

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

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women over 19 years of age 2) Patients with EGFR mutation-positive advanced/metastatic non-small cell lung cancer who have been treated with afatinib or gefitinib for more than 6 months as first-line treatment 3) Patients with confirmed T790M mutation positive in tumor tissue or blood samples after failure of afatinib or gefitinib treatment as first-line treatment 4) Patients who received osimertinib as a second-line treatment after confirming acquired resistance T790M mutation 5) Patients with T790M allele frequency results obtained from tumor tissue or blood samples after afatinib or gefitinib treatment as the first treatment

Exclusion criteria

Exclusion criteria: 1) Patients unable to review medical records 2) Patients with brain metastases Patients with brain metastases

Design outcomes

Primary

MeasureTime frame
Primary endpoint for this study is the allelic frequency of T790M mutation in two Cohorts with tumor tissue or blood samples after first-line EGFR-TKI disease progression.

Secondary

MeasureTime frame
• Objective response rate (ORR) and time on treatment (TOT) according to the T790M allelic frequency and second-/first-line EGFR-TKI treatments. • Additional experimental endpoint on prognostic significance according to the T790M allelic frequency.

Countries

Korea, Republic of

Contacts

Public Contactwonjun ji

Asan Medical Center

jack1097@naver.com+82-2-3010-1699

Outcome results

None listed

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