Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib

Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib - Phase II study of osimertinib in patients with non-small cell lung cancer who acquired resistance to afatinib (ALCSG-04)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028166

Enrollment

Registered

2017-08-01

Start date

2017-08-01

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: Eligibility includes; 1. Patients of lung cancer diagnosed with pathological findings and clinical stage from IIIA to IV. 2. Patients harboring active EGFR gene mutations. 3. Patients having one or more measurable lesions based on RECIST v1.1. 4. Patients aged 20 and over 20, and less than 75 years. 5. Patients who are not treated with chemotherapy, EGFR-TKIs, and Immuno-checkpoint blockades. 6. Patients who can take EGFR-TKIs orally. 7. Patients having adequate organ function. 8. Letter of consent.

Exclusion criteria

Exclusion criteria: Patients are excluded if they have; 1. Severe concomitant disease. 2. Severe history oh hypersensitivity. 3. Severe heart disease or arrhythmia. 4. Interstitial pneumoniae. 5. Active infection. 6. Active peptic ulcer. 7. Active double cancer. 8. Symptomatic brain metastasis.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Countries

Japan

Contacts

Public ContactKaori Onishi

Asahikawa Medical University Hospital Respiratory Center

k-onishi@asahikawa-med.ac.jp0166-65-2111

Outcome results