Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)

Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104) - Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009548

Enrollment

Registered

2012-12-17

Start date

2013-01-07

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

Small-cell lung cancer

Interventions

Patients are treated with amrubicin 35 mg/m2 days 1-3 every 3 weeks. G-CSF are given for at least 4 days from day 8.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed small-cell lung cancer 2.No indication of curative radiotherapy 3.Age 75 years or older 4.ECOG performance status of 0 to 2 5.With measurable lesion(s) according to RECIST 1.1 6.No previous chemotherapy or radiotherapy. Patients who have measurable lesion(s) after palliative radiotherapy to metastasis(es) or surgery are eligible if these treatments are finished at least 14 days ago before enrollment. 7.Adequate organ functions 8.Expected life expectancy of 3 months or more 9.Written informed consent

Exclusion criteria

Exclusion criteria: Patients with any of the following criteria are ineligible. 1.Contraindication for amrubicin 2.Massive pleural or pericardial or ascites that requires drainage 3.Under radiotherapy 4.Symptomatic brain metastasis(es) 5.Superior vena cava symdrome 6.Cardiac dysfunction or myocardial infarction occurred within 6 months or uncontrolled angina pectoris or uncontrolled heart failure 7.Interstitial pneumonitis or pulmonary fibrosis on chest X-ray 8.Uncontrolled diabetes mellitus 9.Other concurrent malignancy 10.Active infection or fever of 38 C or higher 11.History of serious drug allergy 12.Pregnancy or lactation 13.Other concomitant serious medical conditions

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival Overall survival Safety (incidence of adverse events)	—

Countries

Japan

Contacts

Public ContactHIroshi Saito

Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine

hsaito@acc-aichi.com0564-21-6251

Outcome results

None listed

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