Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation

Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation - Phase II study of gefitinib therapy inserted by chemotherapy for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001738

Enrollment

Registered

2009-03-01

Start date

2008-11-01

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

1) Gefitinib 250mg/day orally for 8weeks 2) Gefitinib cessation for 2weeks 3) Chemotherapy (every 21days, 3cycles) Cisplatin 80 mg/m2 day1 Docetaxel 60 mg/m2 day1 4) Gefitinib 250mg/day orally un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed, stage IIIB/IV or post-operative recurrent non-small-cell lung cancer 2) EGFR somatic mutation (exon 19 DEL or exon 21 L858R) (regardless of the sampling and analysis method) 3) No prior chemotherapy (Patients who had taken oral UFT as adjuvant chemotherapy and finished the therapy more than 4weeks ago are eligible) 4) In post-operative recurrent case, 4weeks or longer blank after operation is needed 5) Age over 20 and under 75 years old 6) ECOG performance status 0-2 7) Life expectancy of 12weeks or longer 8) Adequate organ function 9) Written informed consent (Patients who received pleural effusion drainage, pleurodesis, and local palliative radiation therapy are eligible, but patients who received pericardiac effusion drainage are ineligible.)

Exclusion criteria

Exclusion criteria: 1) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) or K-ras mutation 2) CNS metastasis requiring treatment 3) Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT 4) Complications like below a) Active infection b) Acute myocardial infarction, the other severe heart diseases, and arrhythmia within the previous 6months c) Uncontrollable diabetes mellitus d) Uncontrollable hypertension e) Continuous diarrhea and ileus f) Psychological disorders difficult to cooperate in the clinical trial 5) Receiving systemic corticosteroid therapy 6) Active metachronous cancer (disease-free survival of less than 5years) 7) Pregnancy or breast-feeding 8) No intent to practice contraception 9) Difficult to take medicine continuously

Design outcomes

Primary

Measure	Time frame
2-years progression free survival rate	—

Secondary

Measure	Time frame
Response rate Overall survival Toxicity	—

Countries

Japan

Contacts

Public ContactYuichiro Ohe, Shintaro Kanda

National Cancer Center Hospital Thoracic Medical Oncology

skanda@ncc.go.jp03-3542-2511

Outcome results

None listed

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