---
title: Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
nct_id: NCT00660504
overall_status: COMPLETED
phase: PHASE3
sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Lung Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00660504.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00660504"
ct_last_update_post_date: 2014-07-18
last_seen_at: "2026-05-12T07:28:47.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

**Official Title:** Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC

**NCT ID:** [NCT00660504](https://clinicaltrials.gov/study/NCT00660504)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Sumitomo Pharma (Suzhou) Co., Ltd.
- **Conditions:** Lung Cancer
- **Start Date:** 2008-04
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2014-07-18

## Brief Summary

This study drug(Amrubicin)is believed to work by stopping the tumor cell in your body from growing. The purpose of this study is to evaluate the efficacy and safety of amrubicin with cisplatin compared to etoposide-cisplatin in the first-line treatment in extensive disease small cell lung cancer The subject, who is randomized to AP group may be involved into a pharmacokinetic study of amrubicin and the metabolites: amrubicinol voluntarily.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Histologically/cytologically proven small cell lung cancer
* Extensive disease
* No prior chemotherapy regimen
* Age 18 years or older
* ECOG performance status of 0-1

Exclusion Criteria:

* Brain metastasis requiring treatment
* Treatment (Surgical or radiotherapy)of primary tumor
* Interstitial pneumonia or pulmonary fibrosis
* Abnormal cardiac function or myocardial infraction within 6 months before study enrollment
```

## Arms

- **1** (EXPERIMENTAL) — Amrubicin Hydrochloride-Cisplatin combined chemotherapy
- **2** (ACTIVE_COMPARATOR) — Etoposide-Cisplatin combined chemotherapy

## Interventions

- **Amrubicin Hydrochloride** (DRUG) — Amrubicin Hydrochloride combined with cisplatin
- **Etoposide-Cisplatin combined chemotherapy** (DRUG) — combined chemotherapy

## Primary Outcomes

- **Overall Survival** _(time frame: 1.5 years after last subject enrolled)_

## Secondary Outcomes

- **Progression-Free Survival** _(time frame: 1.5 years after last subject enrolled)_
- **Objective Response Rate** _(time frame: participants were followed for the duration of the study, an average of 12 weeks)_

## Locations (15)

- Fuzhou, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian/Shenyang, Liaoning, China
- Shenyang, Liaoning, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
- Tianjin, China

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.|fuzhou|fujian|china` — added _(2026-05-12)_
- `locations.|lanzhou|gansu|china` — added _(2026-05-12)_
- `locations.|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.|changsha|hunan|china` — added _(2026-05-12)_
- `locations.|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.|nanchang|jiangxi|china` — added _(2026-05-12)_
- `locations.|changchun|jilin|china` — added _(2026-05-12)_
- `locations.|dalian/shenyang|liaoning|china` — added _(2026-05-12)_
- `locations.|shenyang|liaoning|china` — added _(2026-05-12)_
- `locations.|xian|shanxi|china` — added _(2026-05-12)_
- `locations.|chengdu|sichuan|china` — added _(2026-05-12)_
- `locations.|hangzhou|zhejiang|china` — added _(2026-05-12)_
- `locations.|beijing||china` — added _(2026-05-12)_
- `locations.|shanghai||china` — added _(2026-05-12)_
- `locations.|tianjin||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00660504.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00660504*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*