Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.
Most patients with extensive disease small cell lung cancer (ED-SCLC) respond to first line(1L) platinum-based chemotherapy; however, responses are not durable and prognosis is poor. Currently no maintenance treatments are approved in SCLC to prolong the durability of efficacy achieved with 1L chemotherapy. Immuno-oncology agents have demonstrated efficacy in the treatment of ED-SCLC when administered across different lines of therapy. Tislelizumab (Anti-PD-1 antibody) Combine Etoposide+ platinum (EP) had improved median Overall survival (mOS ) to 15.6m of 1L ED-SCLC in the Rationale 206 study. Anlotinib ( RTKi ) had significantly improved PFS & OS of 3L(third line) ED-SCLC in the ALTER 1202. This phase II study is designed to explore the effect and safety of the combination as maintenance therapy for ED-SCLC after 1L chemotherapy
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Tislelizumab:200mg Q3W IV Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab:200mg Q3W IV. There will be no dose reduction for Tislelizumab , if there is no disease progression or serious Treatment Related adverse events(TRAE) , patients will receive Tislelizumab (200mg,Q3W) until progression or death |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of progression free survival | Rate of progression free survival in 6 month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | OS | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, MD | Contact | 86-10-87788293 | syuankaipumc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, MD | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | 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 |
|---|---|
| C000707970 | tislelizumab |
| C000625192 | anlotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anlotinib hydrochloride | Drug | Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated. Depending tolerated dose reduction. Medication process: disease control and patients can tolerate the side effects, continued drug use; researchers believe the patient is not fit to continue medication or efficacy evaluation at the end of the clinical progression of medication. |
|
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |