Post-line Treatment with Teniposide for C-Myc-driven Extensive-stage Small Cell Lung Cancer

Phase 2

Not yet recruiting

• Conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC); Thoracic Neoplasms; Lung Neoplasms; Lung Diseases
• Interventions: Drug: Teniposide administration

• Registration Number: NCT06758700
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2024-12-26
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-01-07
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teniposide group	Teniposide administration	Teniposide administration

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0	From Baseline up to 30 days after the last dose
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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China