Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
ID06758700

Phase II Study Evaluating Teniposide as Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2025-12-05

15

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Shanghai Pulmonary Hospital, Shanghai, China

Lead Sponsor

C

CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer (ES-SCLC) who have high expression of the c-Myc-driven FBXW2/MYC gene and have not responded to standard treatments. This phase II clinical study aims to explore how the expression of FBXW2/MYC correlates with the treatment effects of teniposide in this patient group. Participants will receive teniposide administered intravenously at a dose of 60 mg/m2, diluted in 500 ml of 0.9% sodium chloride, infused over more than one hour daily for 3 to 5 consecutive days. One treatment cycle lasts 21 days. Imaging evaluations will be performed at the start and then every 6 to 8 weeks during treatment, with an average study duration of one year. During the study, researchers will monitor the objective response rate through imaging, as well as disease control rate, progression-free survival, and duration of response. Safety monitoring includes tracking adverse and serious adverse events from baseline until 30 days after the last dose. Participants can expect regular assessments and imaging scans throughout their involvement, which may last about one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with extensive-stage small cell lung cancer
  • Progression after receiving at least one chemotherapy treatment
  • ECOG performance status score of 0 or 1
  • c-Myc-driven cancer expression
  • Expected survival of at least 3 months
  • Age between 18 and 75 years
  • Signed informed consent following ICH-GCP principles
Not Eligible

You will not qualify if you...

  • No measurable lesions present
  • Severe or persistent diseases or organ dysfunction
  • Women planning pregnancy or men planning family planning
  • Women who are pregnant or breastfeeding
  • Unable to follow the study protocol provided by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Repeated 21-day cycles until disease progression or discontinuation

Participants receive Teniposide through intravenous infusion for 3 to 5 consecutive days per cycle, with each cycle lasting 21 days.

Baseline and imaging visits every 6 to 8 weeks during treatment

Follow-up

Duration - Up to 30 days after last dose

Participants are monitored for adverse events up to 30 days after the last dose of Teniposide.

Regular safety monitoring visits

Trial Site Locations

Total: 1 location

1

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, China, 200331

Actively Recruiting

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Research Team

J

jiale Wang

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

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.

P E Postmus, H Haaxma-Reiche, E F Smit...

https://pubmed.ncbi.nlm.nih.gov/11013281

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.

P E Postmus, E F Smit, H Haaxma-Reiche...

https://pubmed.ncbi.nlm.nih.gov/7884426

Proteogenomic characterization of small cell lung cancer identifies biological insights and subtype-specific therapeutic strategies.

Qian Liu, Jing Zhang, Chenchen Guo...

https://pubmed.ncbi.nlm.nih.gov/38181741

Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...

https://pubmed.ncbi.nlm.nih.gov/33538338