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Phase II study of nedaplatin for advanced or relapsed squamous cell lung cancer in chemo-naive elderly patients

Phase II study of nedaplatin for advanced or relapsed squamous cell lung cancer in chemo-naive elderly patients - Phase II study of nedaplatin for advanced squamous cell lung cancer in elderly patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007054
Enrollment
25
Registered
2012-01-12
Start date
2011-04-01
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

squamous cell lung cancer

Interventions

Nedaplatin 80-100mg/m2 day 1, q4w until disease progression or intolerable toxicity.

Sponsors

Shizuoka Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. 2) Chemo-naive clinical stage IIIB/IV or relapsed patients. 3) Age of 75 years or older. 4) Performance status (PS) of 0-1 in ECOG criteria. 5) Adequate organ functions. 6) With measurable lesion. 7) Life expectancy more than 3 months. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with brain metastasis in need of steroid or anticonvulsant. 2) Less than 4 weeks after curative radiotherapy to primary lesion or less than 2 weeks after palliative radiotherapy. 3) History of active double cancer. 4) Patients with superior vena cava syndrome. 5) Uncontrollable pleural effusion, pericardial effusion or ascites. 6) History of uncontrollable hypertension, diabetes mellitus, active angina pectoris, active gastrointestinal hemorrhage, recent cardiac incompetence, recent myocardial infarction and active viral infection (except viral hepatitis). 7) Interstitial shadow of UIP (usual interstitial pneumonia) pattern on chest CT. 8) History of severe drug allergy. 9) History of severe psychiatric disease. 10) Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
Overall survival, Progression free survival, Adverse events

Countries

Japan

Contacts

Public ContactTetsuhiko Taira

Shizuoka Cancer Center Division of Thoracic Oncology

055-989-5222

Outcome results

None listed

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