Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

A Randomised, Open-Label Phase 3 Trial Comparing Amrubicin Versus Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01207011

Enrollment

202

Registered

2010-09-22

Start date

2010-10-31

Completion date

2014-06-30

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

The study is to evaluate the effect of amrubicin (AMR) compared to docetaxel (DOC) in the treatment of non-small cell lung cancer (NSCLC).

Interventions

DRUGAmrubicin hydrocloride

AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.

DRUGDocetaxel

DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Histological or cytological diagnosis of non-small cell lung cancer (NSCLC) * 1 or 2 prior chemotherapy regimen including 1 platinum-based chemotherapy * 20 or older but younger than 75 years of age

Exclusion criteria

* Symptomatic brain metastasis * Interstitial pneumonia or pulmonary fibrosis * Abnormal cardiac function or myocardial infraction within 6 months before study enrollment * Active infection

Design outcomes

Primary

Measure	Time frame
Progression free survival	3.3 months

Secondary

Measure	Time frame
Overall survival	12 months
response rate (RECIST)	3 months
Number of Participants with Adverse Events	4 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026