A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation

A Phase II Study of Erlotinib monotherapy for patients with non-small cell lung cancer wihtout EGFR mutation - A phase II study of Erlotinib for NSCLC wihtout EGFR mutation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004207

Enrollment

120

Registered

2010-09-17

Start date

2010-09-01

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

Erlotinib 150 mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hitologically proven NSCLC 2) Patient with recurrent NSCLC of stage IV or after surgery who did not respond to or replapsed prior chemotherapy (<=3). 3) Patients harboring EGFR mutation negative tumor. 4) patients whose tumor tissue are available for EGFR gene copy number, Kras, and cMet. 5) Patients who treated with standard chemotherapy. 6) No prior therapywith EGFR tyrosine kinase inhibitor. 7) ECOG performance status 0-2 8) Patients who have one or more measurable lesion by RECIST. 9) Patiens who ar able to receive treatment by hospitalization for at least 2-4 weeks or under equivalent condition. 10) Age >= 20years at the time ofregestration. 11) adequate organ fuction. 12) Patients who are considered to survive for more than 12 weeks. 13) Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1) severe interstitial lung disease or pulmonary fibrosis. 2) patient with history of drug-related lung disease. 3) Severe drug allrgy. 4) Patients with complication of infectious disease. 5) patients with Severe diarrhea 6) Patients with clinically significant ball disease. 7) patients with clinically significant opthalmologic disorder. 8) patients with complication or hisotry of gastrointestinal perforation. 9) Uncontrolable GI ulcer. 10) Brain metastasis with symptoms 11) Active multiple cancer. 12) patients with clinically significant heart disease. 13) Patients with clinically siginificant psychologic disease. 14) Patients with lactation or pregnancy. 15) patients who are considered ineligible based on decision of a reasonable investigator.

Design outcomes

Primary

Measure	Time frame
Disease contorol rate	—

Secondary

Measure	Time frame
Response rate Overall survival Progression free survival Safety Time to treatment failure	—

Countries

Japan

Contacts

Public ContactTakashi Sone

Kanazawa University Hospital Respiratory Medicine

076-265-2273

Outcome results

None listed

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