Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer

NCT06758700 | Recruiting Phase 2

• 2 other identifiers: VM26-201ChiCTR2400094090
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC); Thoracic Neoplasms; Lung Neoplasms; Lung Diseases

Keywords

c-Myc; SCLC; Phase II; Post-line

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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

  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

  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

  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

  From Baseline up to 30 days after the last dose

Study Arms (1)

Teniposide group

OTHER

Teniposide administration

Drug: Teniposide administration

Interventions

Teniposide administration DRUG

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.

Teniposide group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD: collaborator

Study Sites (1)

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, 200331, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 11013281 BACKGROUND

• 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.

  PMID: 7884426 BACKGROUND

• 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.

  PMID: 38181741 BACKGROUND

• 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.

  PMID: 34508258 BACKGROUND

• 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.

  PMID: 28534531 BACKGROUND

• 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.

  PMID: 33538338 BACKGROUND

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Thoracic Neoplasms; Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Central Study Contacts

jiale Wang

CONTACT

+86 21 65115006; wangjiale200008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 6, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)