Extensive-stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT06758700
Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer
A Phase 2 study testing Teniposide administration in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Thoracic Neoplasms, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Thoracic Neoplasms, Lung Neoplasms
- What is being tested?
- Teniposide administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- extensive stage small cell lung cancer
- Progression after receiving at least one chemotherapy drug treatment in the past;
- ECOG score 0-1
- c-Myc-driven
- Expected survival period ≥3 months
- Age: 18-75 years old;
- The informed consent form complies with the ICH-GCP principles.
Who cannot join
- No measurable lesions
- Other severe and persistent diseases or organ system dysfunction;
- Women planning pregnancy or men planning family planning;
- Women who are pregnant or breastfeeding;
- Those who cannot follow the research protocol provided by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, 200331
Jiale Wang, +86 21 65115006, wangjiale200008@163.com
About this study
Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer
The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.
- Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Thoracic Neoplasms, Lung Neoplasms, Lung Diseases
- Being tested
- Teniposide administration
- Keywords
- c-Myc, SCLC, Phase II, Post-line
- Medical subject headings
- Small Cell Lung Carcinoma, Thoracic Neoplasms, Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teniposide administrationDrug
Teniposide administration: 60mg/m2, diluted with 500ml of 0.9% sodium chloride injection before use, intravenous infusion for more than 1 hour, for 3-5 consecutive days, with 21 days as one cycle of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Teniposide group | Other | Teniposide administration Receives: Drug: Teniposide administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
Secondary outcomes (4)
Disease Control Rate
Measured: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
Progression Free Survial
Measured: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
Duration of Response
Measured: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0
Measured: From Baseline up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start7 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small Cell Lung Cancer (ES-SCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
- Responsible party
- Principal investigator, Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758700
- Sponsor's protocol ID
- VM26-201
- Other IDs
- ChiCTR2400094090
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Postmus PE, Haaxma-Reiche H, Smit EF, Groen HJ, Karnicka H, Lewinski T, van Meerbeeck J, Clerico M, Gregor A, Curran D, Sahmoud T, Kirkpatrick A, Giaccone G. Treatment of brain metastases of small-cell lung cancer: comparing teniposide and teniposide with whole-brain radiotherapy--a phase III study of the European Organization for the Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 2000 Oct 1;18(19):3400-8. doi: 10.1200/JCO.2000.18.19.3400.
PubMed 11013281Postmus PE, Smit EF, Haaxma-Reiche H, van Zandwijk N, Ardizzoni A, Quoix E, Kirkpatrick A, Sahmoud T, Giaccone G. Teniposide for brain metastases of small-cell lung cancer: a phase II study. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1995 Mar;13(3):660-5. doi: 10.1200/JCO.1995.13.3.660.
PubMed 7884426Liu Q, Zhang J, Guo C, Wang M, Wang C, Yan Y, Sun L, Wang D, Zhang L, Yu H, Hou L, Wu C, Zhu Y, Jiang G, Zhu H, Zhou Y, Fang S, Zhang T, Hu L, Li J, Liu Y, Zhang H, Zhang B, Ding L, Robles AI, Rodriguez H, Gao D, Ji H, Zhou H, Zhang P. Proteogenomic characterization of small cell lung cancer identifies biological insights and subtype-specific therapeutic strategies. Cell. 2024 Jan 4;187(1):184-203.e28. doi: 10.1016/j.cell.2023.12.004.
PubMed 38181741Dhanasekaran R, Deutzmann A, Mahauad-Fernandez WD, Hansen AS, Gouw AM, Felsher DW. The MYC oncogene - the grand orchestrator of cancer growth and immune evasion. Nat Rev Clin Oncol. 2022 Jan;19(1):23-36. doi: 10.1038/s41571-021-00549-2. Epub 2021 Sep 10.
PubMed 34508258Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017 Sep;14(9):549-561. doi: 10.1038/nrclinonc.2017.71. Epub 2017 May 23.
PubMed 28534531Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06758700
- Acronym / sponsor ID
- VM26-201
- Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Thoracic Neoplasms, Lung Neoplasms, Lung Diseases
- Keywords
- c-Myc, SCLC, Phase II, Post-line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Jan 2025 (actual)
- 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.
The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Teniposide group | Other | Drug: Teniposide administrationTeniposide administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- extensive stage small cell lung cancer
- Progression after receiving at least one chemotherapy drug treatment in the past;
- ECOG score 0-1
- c-Myc-driven
- Expected survival period ≥3 months
Key exclusion criteria (5 listed)
- No measurable lesions
- Other severe and persistent diseases or organ system dysfunction;
- Women planning pregnancy or men planning family planning;
- Women who are pregnant or breastfeeding;
- Those who cannot follow the research protocol provided 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 |
|---|---|---|
| Teniposide administrationTeniposide administration: 60mg/m2, diluted with 500ml of 0.9% sodium chloride injection before use, intravenous infusion for more than 1 hour, for 3-5 consecutive days, with 21 days as one cycle of treatment. | Drug | Teniposide group |
Primary outcome
Objective Response Rate (ORR)
Time frame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
4 secondary outcomes
Disease Control Rate
Time frame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
Progression Free Survial
Time frame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
Duration of Response
Time frame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, until progression or death, an average of 1 year
Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0
Time frame: From Baseline up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 11013281Postmus PE, Haaxma-Reiche H, Smit EF, Groen HJ, Karnicka H, Lewinski T, van Meerbeeck J, Clerico M, Gregor A, Curran D, Sahmoud T, Kirkpatrick A, Giaccone G. Treatment of brain metastases of small-cell lung cancer: comparing teniposide and teniposide with whole-brain radiotherapy--a phase III study of the European Organization for the Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 2000 Oct 1;18(19):3400-8. doi: 10.1200/JCO.2000.18.19.3400.
- Background: PubMed 7884426Postmus PE, Smit EF, Haaxma-Reiche H, van Zandwijk N, Ardizzoni A, Quoix E, Kirkpatrick A, Sahmoud T, Giaccone G. Teniposide for brain metastases of small-cell lung cancer: a phase II study. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1995 Mar;13(3):660-5. doi: 10.1200/JCO.1995.13.3.660.
- Background: PubMed 38181741Liu Q, Zhang J, Guo C, Wang M, Wang C, Yan Y, Sun L, Wang D, Zhang L, Yu H, Hou L, Wu C, Zhu Y, Jiang G, Zhu H, Zhou Y, Fang S, Zhang T, Hu L, Li J, Liu Y, Zhang H, Zhang B, Ding L, Robles AI, Rodriguez H, Gao D, Ji H, Zhou H, Zhang P. Proteogenomic characterization of small cell lung cancer identifies biological insights and subtype-specific therapeutic strategies. Cell. 2024 Jan 4;187(1):184-203.e28. doi: 10.1016/j.cell.2023.12.004.
- Background: PubMed 34508258Dhanasekaran R, Deutzmann A, Mahauad-Fernandez WD, Hansen AS, Gouw AM, Felsher DW. The MYC oncogene - the grand orchestrator of cancer growth and immune evasion. Nat Rev Clin Oncol. 2022 Jan;19(1):23-36. doi: 10.1038/s41571-021-00549-2. Epub 2021 Sep 10.
- Background: PubMed 28534531Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017 Sep;14(9):549-561. doi: 10.1038/nrclinonc.2017.71. Epub 2017 May 23.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
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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.
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 Teniposide administration in people with Extensive-stage Small Cell Lung Cancer (ES-SCLC) and Thoracic Neoplasms, run by Shanghai Pulmonary Hospital, Shanghai, China 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jiale Wang (+86 21 65115006, wangjiale200008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year). 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 NCT06758700, which also lists 6 linked publications.
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 5 Dec 2025.