Small-cell Lung Cancer
Conditions
Brief summary
This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.
Interventions
DRUGJS201 combine with Lenvatinib
JS201 300mg i.v Q2wLenvatinib 8mg po. Qd
Sponsors
Hunan Province Tumor Hospital
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\. The imaging diagnosis is the extensive stage of SCLC * 2\. The patient failed first-line EC+PD-L1 treatment * 3 PS 0-1
Exclusion criteria
* 1\. Diagnosed as non-small cell lung cancer * 2\. Women during pregnancy * 3\. Patients with symptomatic brain metastases * 4\. PS≥2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 1 year | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang, MD
Outcome results
None listed