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This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab with anlotinib and platinum-based chemotherapy + Adjuvant Tislelizumab | Experimental | Intervention/treatment: Tislelizumab 200mg iv,d1,q3w, Anlotinib 10mg,po,qd1-14,q3w, Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
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| Tislelizumab with platinum-based chemotherapy + Adjuvant Tislelizumab | Other | Tislelizumab 200mg iv,d1,q3w, Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunochemotherapy combined with antiangiogenic | Drug | neoadjuvant: Tislelizumab 200mg iv,d1,q3w, Anlotinib 10mg,po,qd1-14,q3w, Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) in Intent-to-Treat (ITT) analysis set | pathological complete response (pCR): defined as no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment. | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan | Contact | 8615991269383 | yanxiaolong@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Linna Liu | Tang-Du Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital of the Fourth Millitary Medical University | Xi'an | Shaanxi | 710000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2024 | Jun 13, 2024 |
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| Immunochemotherapy | Drug | neoadjuvant:Tislelizumab 200mg iv,d1,q3w, Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab [200 mg, IV; given on cycle day 1]. |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D020533 | Angiogenesis Inhibitors |
| C000707970 | tislelizumab |
| C000625192 | anlotinib |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
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