CompletedNCT00660504Updated Jul 18, 2014Results posted

Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer

A Phase 3 interventional study of Amrubicin Hydrochloride and Etoposide-Cisplatin combined chemotherapy in Lung Cancer, sponsored by Sumitomo Pharma (Suzhou) Co., Ltd.. Completed at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.

Sponsored by Sumitomo Pharma (Suzhou) Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 300
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Lung Cancer

Browse trials for

Lung Neoplasms 7,243

Keywords

Extensive Disease-Small Cell Lung Cancer

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 300 is above the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Sumitomo Pharma (Suzhou) Co., Ltd. is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 300 participants (actual)

Study arms

Experimental
1
Amrubicin Hydrochloride-Cisplatin combined chemotherapy
Drug: Amrubicin Hydrochloride
Active comparator
2
Etoposide-Cisplatin combined chemotherapy
Drug: Etoposide-Cisplatin combined chemotherapy

Interventions

DrugAmrubicin Hydrochloride
Amrubicin Hydrochloride combined with cisplatin
DrugEtoposide-Cisplatin combined chemotherapy
combined chemotherapy

What researchers measure

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
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: participants were followed for the duration of the study, an average of 12 weeks

Other outcomes

Overall Survival at 6 and 12 Months
Time frame: 6 and 12 months.

Results

Posted Jul 4, 2014

Participant flow

Participant flow — Overall Study
Milestone	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Started	149	151
Completed	149	150
Not completed	0	1

Outcome measures

PrimaryOverall Survival

Time frame:: 1.5 years after last subject enrolled
Reported as:: Median · month

Overall Survival
month	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Overall Survival	11.79 (11.01 to 12.62)	10.28 (9.23 to 11.96)

Other pre-specifiedOverall Survival at 6 and 12 Months

Time frame:: 6 and 12 months.
Reported as:: Number · percentage of patients

Overall Survival at 6 and 12 Months
percentage of patients	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
6-month	89.26 (83.07 to 93.28)	86.00 (79.34 to 90.64)
12-month	48.59 (40.31 to 56.36)	41.93 (33.97 to 49.68)

SecondaryProgression-Free Survival

Time frame:: 1.5 years after last subject enrolled
Reported as:: Median · month

Progression-Free Survival
month	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Progression-Free Survival	6.83 (6.11 to 7.39)	5.72 (5.06 to 6.93)

SecondaryObjective Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time frame:: participants were followed for the duration of the study, an average of 12 weeks
Reported as:: Number · percentage of participants

Objective Response Rate
percentage of participants	Amrubicin Combined With Cisplatin Group	Etoposide Combined With Cisplatin Group
Objective Response Rate	69.80	57.33

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Amrubicin, Anticancer, Injection	—	21/149 (14.1%)	149/149 (100%)
Etoposide, Anticancer, Injection	—	8/150 (5.3%)	148/150 (98.7%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
Neutrophil count decreasedInvestigations	7/149	0/150
White blood cell count decreasedInvestigations	6/149	0/150
Bone marrow failureBlood and lymphatic system disorders	5/149	3/150
Febrile neutropenia syndromeBlood and lymphatic system disorders	3/149	0/150
Platelet count decreasedInvestigations	3/149	1/150
DiarrheaGastrointestinal disorders	2/149	0/150
feverInfections and infestations	2/149	0/150
HypokalemiaMetabolism and nutrition disorders	2/149	0/150
Cerebral infarctionNervous system disorders	1/149	2/150
AgranulocytosisBlood and lymphatic system disorders	1/149	0/150

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection
Neutrophil count decreasedBlood and lymphatic system disorders	99/149	85/150
White blood cell count decreasedBlood and lymphatic system disorders	97/149	85/150
NauseaGastrointestinal disorders	72/149	70/150
vomitGastrointestinal disorders	63/149	63/150
Decreased appetiteGastrointestinal disorders	60/149	50/150
Platelet count decreasedBlood and lymphatic system disorders	54/149	40/150
Lower hemoglobinBlood and lymphatic system disorders	49/149	50/150
AnemiaBlood and lymphatic system disorders	48/149	48/150
Bone marrow failureBlood and lymphatic system disorders	46/149	46/150
ConstipationGastrointestinal disorders	32/149	25/150

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection	Total
Mean	56.1 ± 10.03	57.45 ± 9.78	56.78 ± 9.92

Sex: Female, Male
Sex: Female, Male(Participants)	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection	Total
Female	35	37	72
Male	114	113	227

Region of Enrollment
Region of Enrollment(participants)	Amrubicin, Anticancer, Injection	Etoposide, Anticancer, Injection	Total
China	149	150	299

Study locations

15 sites

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

References and documents

Publications

Sun Y, Cheng Y, Hao X, Wang J, Hu C, Han B, Liu X, Zhang L, Wan H, Xia Z, Liu Y, Li W, Hou M, Zhang H, Xiu Q, Zhu Y, Feng J, Qin S, Luo X. Randomized phase III trial of amrubicin/cisplatin versus etoposide/cisplatin as first-line treatment for extensive small-cell lung cancer. BMC Cancer. 2016 Apr 9;16:265. doi: 10.1186/s12885-016-2301-6. PubMed 27061082 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00660504
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Responsible party: Sponsor
First posted: Apr 17, 2008
Start date: Apr 2008
Primary completion: Feb 2012
Completion: Aug 2012
Results posted: Jul 4, 2014
Last update: Jul 18, 2014

Study contacts

Yan Sun, MD

principal investigator · Cancer hospital, Chinese Academy of Medical Science

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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