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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Docetaxel; Drug: Amrubicin hydrocloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207011

D0702035

Details and patient eligibility

About

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

Enrollment: 202 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

1 AMR

Experimental group

Treatment:

Drug: Amrubicin hydrocloride

2 DOC

Active Comparator group

Treatment:

Drug: Docetaxel