Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403)

Randomized comparative study of cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer (OLCSG 0403) - cisplatin, docetaxel, and irinotecan versus cisplatin and docetaxel in patients with stage IIIB or stage IV non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000205

Enrollment

120

Registered

2005-09-13

Start date

2004-03-01

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

Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Interventions

Intervention arm: Cisplatin (60mg/m2, day1), Docetaxel (60mg/m2, day 1), Irinotecan (60mg/m2, day 2) combination chemotherapy Control arm: Cisplatin (80mg/m2, day1), Docetaxel (60mg/m2, day 1) combina

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically and/or cytologically proven NSCLC 2. No prior treatment 3. Age=4,000/cmm and PLT>=100,000/cmm 8. Adequate liver function: T-Bil=60 ml/min 10. Adequate pulmonary function: PaO2>=60 Torr (room air, at rest) 11. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Symptomatic brain metastasis 2. Active concomittant malignancy, history of previous chemotherapy or thoracic radiation therapy for malignancy 3. Clinically significant allergic history 4. Pregnant or lactating women 5. Severe comrbidities 1) Active interstial pneumonia 2) Unstable angina pectoris, or recent history of myocardial infarction 3) Uncntrolled diabetes mellitus 4) Sever active infection 5) Pleural effusion or ascites which require treatment 6) Clinically significant pericardial effusion 7) Other clinical condition which is considered as inappropriate for this study

Design outcomes

Primary

Measure	Time frame
Overall survival Quality of life	—

Secondary

Measure	Time frame
Best overall response Duration of overall response Time to progression Adverse event	—

Countries

Japan

Contacts

Public ContactMasahiro Tabata

Okayama Lung Cancer Study Group Coordinating Office Department of Hematology, Oncology and Respiratory Medicine, Okayama University Hospital

tabata@md.okayama-u.ac.jp086-235-7227

Outcome results

None listed

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