Small Cell Lung Cancer Extensive StagePhase 2NCT02179528
Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer(SCLC)
A Phase 2 study testing Etoposide in people with Small Cell Lung Cancer Extensive Stage, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Pathological diagnosis of small cell lung cancer
- Extensive stage according to American Veteran Staging System
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1
- Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2
- Age≥18 years
- Adequate organ function
- Consent form according with Guideline for Good Clinical Practice of the International Conference on Harmonisation (ICH-GCP)guidelines
- The expected survival≥2 months
Who cannot join
- Pathological diagnosis of mixed small cell lung cancer
- Limited stage according to American Veteran Staging System
- Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator
- Known pre-existing interstitial lung disease
- Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator
- Any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator
- Pregnant or lactating women
- Active phase of hepatitis B virus infection,Active phase of hepatitis C virus infection or known HIV carriers
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100042
Jie Wang, doctor, 0086 1088196456, zlhuxi@163.com
About this study
Official title: Phase 2 Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer
Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. The objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. The investigators will use the peripheral blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
| Study group | Role | What they receive |
|---|---|---|
| etoposide,maintenance therapy | Active comparator | etoposide,25mg qd d1-20，repeat every 28 days Receives: Drug: Etoposide |
| blank control | No intervention | blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung Cancer Extensive StageStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Wang, Peking University Cancer Hospital & Institute
- Investigators
- Jie Wang, doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179528
- Sponsor's protocol ID
- BJCHDTC001
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 12 Sep 2014
- Results posted
- No
Publications
Zhang C, Duan J, He Z, Yang L, Yang S, Zhang Z, Liu Y, Wan R, Lin L, Wu X, Wang W, Wang Q, Wang J. The benefits of etoposide capsules as maintenance therapy for patients with extensive-stage small cell lung cancer: a prospective two-stage, two-center study. J Thorac Dis. 2021 Jan;13(1):343-352. doi: 10.21037/jtd-21-106.
PubMed 33569214
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Small Doses of Etoposide as Maintenance Treatment in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02179528
- Acronym / sponsor ID
- BJCHDTC001
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve Complete Response(CR)/Partial Response(PR) will accept small doses of etoposide as maintenance treatment. The objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. Based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. The investigators will use the peripheral blood to assess circulating tumor cell and cell-free DNA,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etoposide,maintenance therapy | Active comparator | Drug: Etoposideetoposide,25mg qd d1-20，repeat every 28 days |
| blank control | No intervention | –blank control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathological diagnosis of small cell lung cancer
- Extensive stage according to American Veteran Staging System
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST )1.1
- Eastern Cooperative Oncology Group (ECOG) scores for performance status of 0 to 2
- Age≥18 years
Key exclusion criteria (8 listed)
- Pathological diagnosis of mixed small cell lung cancer
- Limited stage according to American Veteran Staging System
- Other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator
- Known pre-existing interstitial lung disease
- Pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator
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 |
|---|---|---|
| Etoposide | Drug | etoposide,maintenance therapy |
Primary outcome
Time to Disease Progression
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Derived from this study: PubMed 33569214Zhang C, Duan J, He Z, Yang L, Yang S, Zhang Z, Liu Y, Wan R, Lin L, Wu X, Wang W, Wang Q, Wang J. The benefits of etoposide capsules as maintenance therapy for patients with extensive-stage small cell lung cancer: a prospective two-stage, two-center study. J Thorac Dis. 2021 Jan;13(1):343-352. doi: 10.21037/jtd-21-106.
Related trials for Small Cell Lung Cancer Extensive Stage
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
Jie Wang, doctor principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide in people with Small Cell Lung Cancer Extensive Stage, run by Peking University Cancer Hospital & Institute at 1 site 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang, doctor (0086 108816456, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: up to 12 months). 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 NCT02179528, 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 12 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.