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

Phase 2RecruitingNCT06758700

Shanghai Pulmonary Hospital, Shanghai, China15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. 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.

Outcomes

Primary Outcomes

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

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

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

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

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