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A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients without Epidermal Growth Factor Receptor Mutation

A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer Patients without Epidermal Growth Factor Receptor Mutation - A Phase II Study of Erlotinib for previously treated Non-small cell Lung Cancer without EGFR Mutation

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002692
Enrollment
54
Registered
2009-11-01
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

Sponsors

Central Japan Lung Study Group (CJLSG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with pathologically proven non-small cell lung cancer. 2) Patients with stage IIIB or IV who are not candidates for curative radiotherapy. 3) Patients with EGFR wild type *Gene analysis by PNA-LNA PCR clamp method. 4) No prior treatment with medicine concerning HER(gefitinib, trastuzumab, lapatinib, cetuximab,etc.). 5) Patients who have previously treated one or two chemotherapy(prior chemotherapy consisting of platinum agents in at least one regimen). 6) Patient who has at least one or more measurable lesion by RECIST. 7) ECOG performance status (PS): 0-2 8) Patients who can be hospitalized for four weeks after beginning of the treatment or under management to apply to it. 9) Patients aged 20 years or older. 10) Adequate organ function. 11) Patients who are considered to survive for more than 3 months. 12) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Active infection or other serious disease condition (poorly controlled diabetes mellitus,cardiac disease, Unstable angina, Cardiac infarction, Psychological illness, etc.). 2) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 3) Massive pleural effusion, pericardial effusion, ascites, and superior vena cava syndrome. 4) Symptomatic brain metastasis. 5) Severe drug allergy. 6) Previous radiotherapy to primary lung cancer. 7) Patients who have previously treated three or more chemotherapy. 8) Patients who had a relapse after surgery. 9) With active double cancer. 10) Pregnancy or lactation. 11) Severe disorder of the eye. 12) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Design outcomes

Primary

MeasureTime frame
Rseponse rate

Countries

Japan

Contacts

Public ContactMasashi Kondo, Masahiro Morise, Tetsunari Hase

Nagoya University Graduate School of Medicine Department of Respiratory Medicine

cjlsg@med.nagoya-u.ac.jp052-744-2176

Outcome results

None listed

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