A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer

A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer - A phase II study of osimertinib in patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027655

Enrollment

Registered

2017-06-07

Start date

2017-06-12

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

Patients with poor performance status and EGFR mutation T790M-positive non-small-cell lung cancer

Interventions

Osimertinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) ECOG PS 2, 3, or 4 2) Pathologically confirmation of non squamous non-small-cell lung cancer 3) Advanced non-small-cell lung cancer 4) History of using first-generation or second-generation EGFR-TKI 5) EGFR mutation with T790M in exon 20 6) Aged 20 or more 7) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of using third-generation EGFR-TKI 2) Uncontrolled symptomatic brain metastasis 3) Interstitial pneumonia or pulmonary fibrosis on imaging 4) QTc > 500 msec 5) Gastrointestinal disorder 6) Uncontrollable pleural effusion , ascites or pericardial effusion 7) Receiving the radiation therapy for chest 8) 28th or less days from the last dosage of immunocheckpoint therapy 9) Severe complication

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Safety, Response rate, Improvement rate of performance status, Overall survival	—

Countries

Japan

Contacts

Public ContactKazuhisa Nakashima

Shimane University Faculty of Medicine Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine

kazuhin@med.shimane-u.ac.jp(+81)055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026