Lung CancerPhase 3NCT00660504
Phase3 Study of Amrubicin With Cisplatin Versus Etoposide-cisplatin for Extensive Disease Small Cell Lung Cancer
A Phase 3 study testing Amrubicin Hydrochloride and Etoposide-Cisplatin combined chemotherapy in people with Lung Cancer, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 15 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Amrubicin Hydrochloride and Etoposide-Cisplatin combined chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 15 sitesChina
- Study dates
- Apr 2008to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically proven small cell lung cancer
- Extensive disease
- No prior chemotherapy regimen
- Age 18 years or older
- ECOG performance status of 0-1
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Study site
Beijing
Study site
Changchun, Jilin
Study site
Changsha, Hunan
Study site
Chengdu, Sichuan
Study site
Dalian/Shenyang, Liaoning
Study site
Fuzhou, Fujian
Study site
Guangzhou, Guangdong
Study site
Hangzhou, Zhejiang
Study site
Lanzhou, Gansu
Study site
Nanchang, Jiangxi
Study site
Nanjing, Jiangsu
Study site
Shanghai
Study site
Shenyang, Liaoning
Study site
Tianjin
Study site
Xian, Shanxi
About this study
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
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
- Lung Cancer
- Being tested
- Amrubicin Hydrochloride, Etoposide-Cisplatin combined chemotherapy
- Keywords
- Extensive Disease-Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amrubicin HydrochlorideDrug
Amrubicin Hydrochloride combined with cisplatin
Etoposide-Cisplatin combined chemotherapyDrug
combined chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Amrubicin Hydrochloride-Cisplatin combined chemotherapy Receives: Drug: Amrubicin Hydrochloride |
| 2 | Active comparator | Etoposide-Cisplatin combined chemotherapy Receives: Drug: Etoposide-Cisplatin combined chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1.5 years after last subject enrolled
Secondary outcomes (2)
Progression-Free Survival
Measured: 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.
Measured: participants were followed for the duration of the study, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionFeb 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Sun, MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660504
- Sponsor's protocol ID
- D0750018
- Other IDs
- D0750018
- Status last verified
- Jul 2014
- First submitted
- 10 Apr 2008
- Last updated
- 18 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00660504
- Acronym / sponsor ID
- D0750018
- Conditions
- Lung Cancer
- Keywords
- Extensive Disease-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Posted 4 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Amrubicin HydrochlorideAmrubicin Hydrochloride-Cisplatin combined chemotherapy |
| 2 | Active comparator | Drug: Etoposide-Cisplatin combined chemotherapyEtoposide-Cisplatin combined chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically/cytologically proven small cell lung cancer
- Extensive disease
- No prior chemotherapy regimen
- Age 18 years or older
- ECOG performance status of 0-1
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amrubicin HydrochlorideAmrubicin Hydrochloride combined with cisplatin | Drug | 1 |
| Etoposide-Cisplatin combined chemotherapycombined chemotherapy | Drug | 2 |
Primary outcome
Overall Survival
Time frame: 1.5 years after last subject enrolled
2 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27061082Sun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Sun, MD principal investigator
Cancer Hospital Chinese Academy of Medical Science
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amrubicin Hydrochloride and Etoposide-Cisplatin combined chemotherapy in people with Lung Cancer, run by Marubeni Pharmaceuticals (Suzhou) Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1.5 years after last subject enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014; AzTrials last refreshed its copy on 7 Nov 2026.