Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hunan Cancer Hospital | OTHER |
| Wuhan TongJi Hospital | OTHER |
Not provided
Not provided
Not provided
To evaluates the effectiveness and safety of Surufatinib combined with Serplulimab plus chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Surufatinib combined with Serplulimab
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib Combined With Serplulimab and EC Chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib,Serplulimab,Etoposide,Carboplatin | Drug | In dose escalation, Surufatinib will be administered orally (PO) once daily (QD) ,d1-21,q3w + Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w + Carboplatin AUC=5,d1,q3w; 4-6 cycles in total. At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21,q3w+Serplulimab 4.5 mg/kg ivgtt,d1,q3w+Etoposide 100mg/m2,d1-3,q3w + Carboplatin AUC=5,d1,q3w, 4-6 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21,q3w+Serplulimab 4.5 mg/kg ivgtt,d1,q3w until the disease progressed. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival(PFS) | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | up to 24 months | |
| Overall Survival(OS) | up to 24 months | |
| Disease control rate(DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gen Lin, Ph.D | Contact | +86-13313786157 | fjzllg133@fjzlhospital.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Fuzhou | Fujian | 350000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717729 | surufatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |