A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.

A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer. - A Phase II Clinical Trial of Nedaplatin and Amurubicin Therapy for Advanced and Recurrent Squamous Cell Lung Cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007587

Enrollment

Registered

2012-03-27

Start date

2012-01-01

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 carcinoma

Interventions

Nedaplatin 100mg/m^2 on day 1 Amrubicin 25mg/m^2 on day 1-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed squamous cell lung carcinoma. 2)Patients with clinical stageIIIb- IV or postoperative recurrence. 3)no previous chemotherapy. 4)ECOG PS 0-1. 5)Patients with measurable leision (RECIST) . 6)Over 20 yeas old, under 75 years old. 7)Adequate main organ and bone marrow function filled below criteria. Leukocyte counts >= 4,000/mm3. Neutrophil counts>= 2,000 /mm3. Platelets >= 100,000 /mm3. Hemoglobin >=9.0 g/dL. AST, ALT< 2x upper normal limit. T-Bil< 1.5 mg dL. s-Cr < upper normal limit. PaO2 >= 60 Torr or SpO2 >= 95%. 8)patients who has the following periods. palliative radiotherapy(ex-thorax):2weeks. Lobectomy of one or more lobe:4 weeks. Operation without lobectomy. chest drainage:2weeks. radiotherapy for lung in perioperative period:6 months. Patients have the prospective for surviving more than 12 weeks. Patients providing written informed consent.

Exclusion criteria

Exclusion criteria: 1)Symptomatic or apparent interstitial pneumonia/lung fibrosis on X-ray image findings. 2)Patients wth uncontrollable fever. 3)Severe complications, such as cardiac. failure, uncontrollable diabetic or hypertension. 4)uncontrollable pleural effusion, pericardial effusionor ascites. 5)Active concomitant malignancy. 6)Severe drug allergies or history of drug hypersensitivity. 7)With active infection. 8)mental disorder. 9)Pregnant, lactating or women of child-bearing potential. 10)The case that is judged to be inadequacy for this study.

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression-free survival, Overall survival	—

Countries

Japan

Contacts

Public ContactHirokazu Taniguchi

Nagasaki University Hospital Second Department of Internal Medicine

hitaniguchi-ngs@umin.ac.jp0958197273

Outcome results

None listed

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