Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Squamous Cell Lung Cancer - Amrubicin in Advanced Squamous Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004235

Enrollment

Registered

2010-10-01

Start date

2010-10-01

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

Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1-3 every 3 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer. 2) Patients who have previously treated with chemotherapy. 3) Patient who has at least one or more measurable lesion by RECIST. 4) (1)Chemotherapy without EGFR TKIs: more than 21 days after the last chemotherapy (2)Chemotherapy with EGFR TKIs: more than 14 days after the last chemotherapy (3)Radiation: more than 14 days after the irradiation 5) ECOG performance status (PS): 0-2 6) Patients aged of 20 to 74 years. 7) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: Leukocyte counts, 4,000/mm3 or over. Neutrophil counts, 2,000/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.5g/dL or over AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, x 1.5 of ULN or less. Arterial oxygen partial pressure 60 Torr or above(SpO2 90% or above can be used instead of arterial oxygen partial pressure). Adequate heart function by ECG. 8) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who have previously treated with chemotherapy containing amrubicin. 2) Patients with symptomatic brain metastasis. 3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites. 4) Patients with active severe infections 5) Patients with double cancer within 5 years. 6) Patients with active interstitial pneumonia recognized by chest X-ray. 7) Patients with serious drug allergic reactions. 8) Patients with active concomitant pregnancy. 9) Patients can not prevent a pregnancy. 10) Patients with cardiac infarction or unstable angina within 12 months. Patients need to recieve medications for their bad heart function. 11) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2. 12) a serious or uncontrolled concomitant systematic disorder (active gastric or duodenal ulcer, uncontrolled diabetes mellitus, or cerebral infarction within 6 months.) 13) Conditon requiring chronic systematic administration of corticosteroids. 14) Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
Disease Control Rate (DCR)	—

Secondary

Measure	Time frame
Overall survival (OS) Progression-free survival (PFS) Response Rate (RR) Toxicity profiles	—

Countries

Japan

Contacts

Public ContactHironori Uruga

Federation of National Public Service Personnel Mutual Aid Associations TORANOMON HOSPITAL Department of Respiratory Medicine

Outcome results

None listed

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