Clinical trial NCT06758700: Post-line Treatment with Teniposide for C-Myc-driven Extensive-stage Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC)
Thoracic Neoplasms
Lung Neoplasms
Lung Diseases
Keywords: c-Myc
SCLC
Phase II
Post-line
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
First posted: 2025-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.


Eligibility criteria: Inclusion Criteria:

1. extensive stage small cell lung cancer
2. Progression after receiving at least one chemotherapy drug treatment in the past;
3. ECOG score 0-1
4. c-Myc-driven
5. Expected survival period ≥3 months
6. Age: 18-75 years old;
7. The informed consent form complies with the ICH-GCP principles.

Exclusion Criteria:

1. No measurable lesions
2. Other severe and persistent diseases or organ system dysfunction;
3. Women planning pregnancy or men planning family planning;
4. Women who are pregnant or breastfeeding;
5. Those who cannot follow the research protocol provided by the investigator.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 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:
measure: Disease Control Rate
timeFrame: Image evaluations were conducted at baseline and every 6-8 weeks after the administration of teniposide, through study completion, an average of 1 year
measure: Progression Free Survial
timeFrame: 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
measure: Duration of Response
timeFrame: 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
measure: Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0
timeFrame: From Baseline up to 30 days after the last dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital, Shanghai, China
state: Shanghai
Study officials:
References:
citation: 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.
citation: Postmus 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.
citation: Liu 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.
citation: Dhanasekaran 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.
citation: Sabari 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.
citation: Sung 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.