RecruitingPhase 2NCT06758700

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

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


Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

15 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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.

Exclusion Criteria5

  • 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.

Interventions

DRUGTeniposide administration

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.


Locations(1)

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, China

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NCT06758700


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