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This is a phase II, single arm, open-label, single-center study to evaluate the efficacy and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 inhibitors)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab, Chemotherapy and Antiangiogenic Agents | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab, Anlotinib and Chemotherapy | Drug | Combination therapy: Toripalimab 240mg will be intravenously administered on Day 1, Q3W; anlotinib: 12 mg qd d1-d14, d15-d21 discontinued, Q3W; investigator selected chemotherapy regimen (paclitaxel, pemetrexed or gemcitabine and other chemotherapeutic drugs which were not administered in the first-line therapy) for a total of 4 cycles. Maintenance therapy: After combination therapy, Patients who achieved complete response(CR), partial response (PR), or stable disease (SD) were administered with toripalimab plus anlotinib as maintenance therapy. until disease progression or intolerable toxicity, treatment for 2 years, investigator decision, withdrawal of consent, or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival | Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. | until Progressive Disease (PD) or death (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy. | each 21 days up to intolerance the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongying Liu | Contact | +86 022 23340123 | 1157 | ldytjnk@sina.com |
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| Overall Survival | Overall survival is defined as the time until death due to any cause. | from first dose of study treatment until death (up to 24 months) |
| Disease Control Rate | Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. | each 21 days up to intolerance the toxicity or PD (up to 24 months) |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
| C000625192 | anlotinib |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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