A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations

A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations - A Phase II Study for the efficacy and safety of Erlotinib for Patients previously treated Non-small cell Lung Cancer Patients with EGFR Mutations

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003215

Enrollment

Registered

2010-02-20

Start date

2009-11-01

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

Single agent chemotherapy with Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients having EGFR mutation, stage IIIB, IV or relapsed NSCLC previously treated with 1-3 regimens of chemotherapy. 2) Patients who has measurable lesion. 3) ECOG performance status (PS): 1 or less 4) Patients aged 20 years or older. 5) Sufficient function of main organ and bone marrow filled the following criteria. WBC >=3,000/mm3 Neu >=1,500/mm3 PLT >=10x104/mm3 Hb >=9.0g/dL sCr <=1.5mg/dL GOT,GPT x 2.5 of upper limit of normal or less T-Bil <=1.5mg/dL PaO2 >=70torr 6) Patients who are considered to survive for more than 3 months. 7) Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1)Active infection (fever) 2)Cases with past history of EGFR-TKI 3)Presence of active interstitial lung disease or pulmonary fibrosis 4)Patients with massive pleural or prericardial effusion or ascites 5)Patients with uncontrollable complications 6)Patients with active double cancer 7)Pregnancy or lactation. 8)Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Design outcomes

Primary

Measure	Time frame
rseponse rate	—

Secondary

Measure	Time frame
Evaluation of safety, Progression free survival, Median survival time	—

Countries

Japan

Contacts

Public ContactHiroki Sakakibara, Yuji Saito, Yoshitaka Totani

Fujita Health Universty Hospital Division of Respirology and Allergology

0562-93-9241

Outcome results

None listed

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