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The primary objective of the perioperative study is to evaluate pathological complete response in resectable II-IIIB(N2) KRAS-mutated nonsquamous non-small cell lung cancer participants receiving tislelizumab plus platinum-based doublet chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab plus platinum doublet chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | administered via Intravenous (IV) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) rate | Up to 3 months following completion of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) rate | Up to 3 months following completion of neoadjuvant treatment | |
| Objective Response Rate (ORR) | Up to 3 years | |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for enrollment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Yao | Contact | 021-22200000-12345 | yaofeng@shsmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | administered via IV infusion |
|
| Carboplatin | Drug | administered via IV infusion |
|
| Pemetrexed Disodium | Drug | administered via IV infusion |
|
| Up to 3 years |
| Overall survival (OS) | Up to 3 years |
| Number of participants experiencing treatment-emergent adverse events (TEAEs) | Up to 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |