Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer

Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer - Phase 1-2 Study of Amrubicin plus Nedaplatin for Advanced Non-Small-Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003282

Enrollment

Registered

2010-03-03

Start date

2009-06-01

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

Nedaplatin 100mg/m^2 on day 1, Amrubicin 25-40mg/m^2 on day 1,2 and 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically proven non-small cell lung cancer 2.Stage IIIB and Stage IV postoperative recurrence 3.no previous chemotherapy 4.a life expectancy of 12 weeks or more 5.Measurable by RECST criteria (Phase 2) 6.age range under 75 years 7.ECOG performance status of 0 or 1 8.adequate bone marrow, liver, and renal functions WBC > 4000 mm-3 Hb > 9.0 g/dL-1 T-Bil< 1.5 mg dL-1 AST, ALT< 2x upper normal limit s-Cr < upper normal limit 9.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Symptomatic pericardial effusion 2.Symptomatic SVC syndrome required emergency radiation 3.Serious medical complications 4.uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. 5.Uncontrolled diabetes mellitus, hypertension, infection 6.Pulmonary fibrosis detectable on chest X-ray films 7.Concomitant malignancy 8.Pregnant or milk-feeding female 9.Symptomatic brain metastasis 10.Other clinical difficulties to this study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Safety	—

Countries

Japan

Contacts

Public ContactDaiki Ogawara

Nagasaki Goto Chuoh Hospital Internal Medicine

bomb0416@yahoo.co.jp0959-72-3181

Outcome results

None listed

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