Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study.

Efficacy and safety of erlotinib in elderly patients with non-small-cell lung cancer harboring epidermal growth factor receptor mutations: A phase 2 study. - Efficacy and safety of erlotinib in elderly patients with EGFR-mutations-positive NSCLC.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010525

Enrollment

Registered

2013-04-17

Start date

2013-04-17

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

Elderly patients with EGFR-mutations-positive non-small-cell lung cancer receive elrotinib.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participants must meet the following criteria. 1: Histologically or pathologically proven NSCLC; stage 3B, 4, or reccurence. 2: EGFR mutation positive. 3: Aged 75 years or older. 4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 4: Stage 3B/4 NSCLC. 5: Chemotherapy naive or received 1 regimen chemotherapy. 6: Never administerd EGFR-TKI. 7: a. Hemoglobin: more than 9.0 g/dL. b. Neutrophil count: more than 3,000/uL. c. Platelet count: more than 100,000/uL. d. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range. e. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range. 8: Life expectancy of more than 3 months. 9: Written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows 1: History of severe allergic reactions to drugs. 2: Pregnancy or lactation. 3: Willing to get pregnant. 4: Interstitial lung disease. 5: Severe infection. 6; Severe and unstable medical comorbidities. 7: Difficulty in ingestion. 8: Uncontrolled brain metastases. 9: EGFR T790M mutation. 10: Judgment to attending physician.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival, overall survival, safety, QOL score	—

Countries

Japan

Contacts

Public ContactYusuke Inoue

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

y.inoue@hama-med.ac.jp053-435-2111

Outcome results

None listed

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