Phase II study of nedaplatin plus irinotecan for stage III/IV squamous cell lung cancer (TORG0910)

Phase II study of nedaplatin plus irinotecan for stage III/IV squamous cell lung cancer (TORG0910) - Phase II study of nedaplatin plus irinotecan for squamous cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003330

Enrollment

Registered

2010-03-15

Start date

2010-04-01

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

Unresectable stage III/IV and relapsed after resection squamous cell lung cancer

Interventions

nedaplatin 100mg/m2 (day1) and irinotecan 60mg/m2 (day1,8), every 4-5 weeks, total 4-6 courses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Squamous cell lung cancer 2)Unresectable stage III/IV and postoperative relapsed squamous cell lung cancer 3)Chemotherapy naive 4)Target lesion is measurable 5)More than 20 years old, less than 75 years old 6)Expected survival is more than 12 weeks 7)ECOG Performance Status 0-1 8)Adequate hematologic, hepatic, and renal functions. 9)More than 2week rest period after palliative radiation or control of pleural effusion 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Massive pleural effusion 2)Massive pericardial effusion 3)double cancer 4)severe complications; myocardial infarction, unstable angina, heart failure, uncontrolled hypertension, ued uncontrolled diabetis mellitus, uncontrolled infection, uncontrolled mental disease, SVC syndrome 5)irinotecan contraindication; watery diarrhea, ileus, digestive organs bleeding, jaundice, bone marrow suppression 6)nedaplatin contraindication; renal failure 7)lung fibrosis 8)pregnancy 9)other inappropriate cases

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
overall survival, progression disease free survival, adverse event rate	—

Countries

Japan

Contacts

Public ContactHaruhiro Saito

Kanagawa Cancer Center Thoracic Oncology

saito-h@kcch.jp045-391-5761

Outcome results

None listed

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