Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens

Phase II study of amrubicin for non-small lung cancer after failure of two or three prior chemotherapy regimens - Phase II study of Third-line AMR for NSCLC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002306

Enrollment

Registered

2009-08-07

Start date

2009-08-01

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

NSCLC after failure of two or three prior chemotherapy regimes

Interventions

Amrubicin 35mg/m2 is administered from day 1 to day 3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-small cell lung cancer 2)Failure of two or three prior chemotherapy regimens containing platinum drug (CDDP or CBDCA) combination (including molecular target drug or adjuvant chemotherapy) 3)With measurable lesion 4)ECOG performance status of 0 to 2 5)Under 75 years 6)Adequate bone marrow, lung, liver, renal, and heart functions WBC >= 3,0000 mm-3 Neutro >= 1,500 mm-3 Hb >= 9 g dL-1 Platlets >= 100,000 mm-3 T-Bil <= 1.5 mg dL-1 AST, ALT <= two times of institutional normal value Ccr >= 50 mL min-1 PaO2 >= 60torr (or SpO2 >= 95%) LVEF >= 60% 7)Life expectancy of 3 months or more 8)Written informed consent for participation to this study

Exclusion criteria

Exclusion criteria: 1)Drug allergy career with inappropriateness for participation to this study 2)Infectious disease or fever of >= 38 degrees Celsius that interferes to this treatment 3)Using oral steroid or immunosuppressive drug 4)Serious medical complications (severe heart disease/cerebrovascular disorder, severe hypertension, active digestive ulcer, uncontrolled diabetes mellitus etc.) 5)Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan 6)Previous amrubicin use 7)Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs 8)Requirement of emergent therapy for pleural effusion, ascites, and pericardial effusion 9)Symptomatic brain metastasis 10)Concomitant malignancy 11)Heart disease that becomes obstacle for this sutdy 12)Psychological/mental illness that becomes obstacle for participation to this sutdy inappropriateness for participation to this study 13)Pregnant, milk-feeding, possibility becoming pregnant female 14)Other clinical inappropriateness to this study

Design outcomes

Primary

Measure	Time frame
Disease control rate	—

Secondary

Measure	Time frame
Overall survival, Progression-free survival, Objective response rate, Safety	—

Countries

Japan

Contacts

Public ContactToshiyuki Harada

Hokkaido Social Insurance Hospital Center of Respiratory Diseases

t-harada@hok-shaho-hsp.jp011-831-5151

Outcome results

None listed

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