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NCT Number: NCT06758700

Post-line Treatment With Teniposide 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.

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, 200331, China

Location status: Recruiting

Location contact

Jiale Wang

CONTACT

[email protected]

+86 21 65115006

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

jiale Wang

CONTACT

[email protected]

+86 21 65115006

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Collaborators

  • CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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