A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)

A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425) - Low-dose Erlotinib for Frail Patients with EGFR Mutation-positive Non-Small Cell Lung Cancer(TORG1425)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015949

Enrollment

Registered

2014-12-15

Start date

2015-01-07

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

Erlotinib treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients with pathologically or proven non-small cell lung cancer 2) patients having EGFR mutation (exon 19 or Exon 21) 3) patients with stage IIIB or IV who are not candidates for curative radiotherapy 4) patients without prior chemotherapy for lung cancer and who satisfies either of the followings; i) aged > 80 years old ii) aged 75 - 80 years old and > 6 points Charlson comorbidity index or > P. S. 1 iii) aged 20-74 years old and > 6 points Charlson comorbidity index or > P. S. 2 5) patients who have measurable lesions by RECIST v.1.1 6) adequate laboratory findings as below(within 2 weeks prior registration); - neutrophil > 1,000/mm3 - hemoglobin > 8.0g/dl - platelet > 75,000/mm3 - total bilirubin: within 3 times of upper normal limit - AST, ALT: within 5 times of upper normal limit - SpO2 > 90%(oxygen dosage or not) 7) signed informed consent 8) life expectance more than 4 weeks

Exclusion criteria

Exclusion criteria: 1) prior EGFR-TKI 2) active concomitant malignancy 3) concomitant brain metastasis require radiotherapy 4) interstitial pneumonia or lung fibrosis evident on CT 5) symptomatic ophthalmologic disease 6) patients having clinically important ophthalmic disorder 7) patients having clinically important neuropsychiatric disorder 8) pregnant or lactating women or those who declined contraception 9) patients judged to be not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
-Disease Control Rate -Response Rate containing SD patients after dose escalation -Safety -Progression Free Survival -Overall Survival	—

Countries

Japan

Contacts

Public ContactShingo Miyamoto

Japanese Red Cross Medical Center Division of Chemotherapy Department of Internal Medicine

torg1425@med.jrc.or.jp03-3400-1311

Outcome results

None listed

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