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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Treatment arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS201 combine with Lenvatinib | Drug | JS201 300mg i.v Q2wLenvatinib 8mg po. Qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong Yang, MD | Contact | +8613055193557 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |