Extensive-stage Small Cell Lung Cancer (ES-SCLC), Lung Diseases, Lung Neoplasms, Thoracic Neoplasms
Conditions
Keywords
c-Myc, SCLC, Phase II, Post-line
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.
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.
Sponsors
CHINA RESOURCES DOUBLE-CRANE PHARMACEUTICAL CO.,LTD
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Adverse events(AEs), serious adverse events（SAEs）as assessed by CTCAE v5.0 | From Baseline up to 30 days after the last dose |
Countries
China
Contacts
Primary Contactjiale Wang
Outcome results
None listed