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This is a prospective, single arm, multicenter phase II study aimed at evaluating the efficacy and safety of Envafolimab combined with standard platinum containing dual drug chemotherapy and Recombinant Human Endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" | Experimental | Envafolimab: 300 mg,D1,Q3W, until PD or intolerable toxicity. Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w. Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles. Recombinant Human Endostatin:210mg,CIV 72h,d1-3,Q3W,4-6 cycles in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Envafolimab" and "Chemotherapy" and "Recombinant Human Endostatin" | Drug | Envafolimab: 300 mg,D1,Q3W,until PD or intolerable toxicity Chemotherapy: Paclitaxel / NAB-Paclitaxel, 175 / 260mg / m2, D1, Q3w; Cisplatin: 75mg / m2, 1-3 days, or carboplatin: AUC 5, D1, Q3w, 4-6 cycles in total. Recombinant Human Endostatin:210mg,CIV 72h,d1-3,Q3W,4-6 cycles in total. |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year PFS rate | 12-month progression free survival in ITT population | 12 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The proportion of subjects with complete response (CR) and partial response (PR) in total subjects | 24 months after the last subject participating in |
| DOR | DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lian Liu, Doctor | Contact | 18560082903 | tounao@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong univertisy | Recruiting | Jinan | Shandong | 250012 | China |
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|
| 24 months after the last subject participating in |
| PFS | Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first | 24 months after the last subject participating in |
| OS | OS is defined as the time from the starting date of study drug to the date of death due to any cause. | 24 months after the last subject participating in |
| Shandong Cancer Hospital | Not yet recruiting | Jinan | China |
|
| ID | Term |
|---|---|
| C000718749 | envafolimab |
| D004358 | Drug Therapy |
| D043169 | Endostatins |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D043165 | Angiostatic Proteins |
| D042501 | Angiogenic Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D043170 | Collagen Type XVIII |
| D024041 | Non-Fibrillar Collagens |
| D003094 | Collagen |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D001685 | Biological Factors |
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