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The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).
This is a randomized, open-label, multicenter, Phase III clinical study. Participants with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6010 + Enlonstobart | Experimental |
| |
| Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6010 | Drug | SYS6010 |
| |
| Enlonstobart |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival (DFS) assessed by the independent review committee (IRC) | DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event. | Up to approximately 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to the date of death(whatever the cause). | Up to approximately 60 months |
| DFS assessed by investigators | DFS was defined as the time from randomization to either the date of disease recurrence as assessed by investigators per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event. |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 031169085587 | ctr-contact@cspc.cn |
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Randomized, open-label
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| Drug |
Enlonstobart |
|
|
| Tislelizumab | Drug | administered via Intravenous (IV) injection |
|
|
| Toripalimab ±+platinum-based doublet chemotherapy | Drug | Cisplatin; Carboplatin; Pemetrexed; Paclitaxel; |
|
|
| Durvalumab | Drug | Durvalumab |
|
|
| Pembrolizumab | Drug | Pembrolizumab |
|
|
| Nivolumab | Drug | Nivolumab |
|
|
| Up to approximately 60 months |
| Incidence and severity of Adverse Events (AEs) | Approximately 15 months |
| EORTC QLQ-30 questionnaire | Approximately 13 months |
| Blood concentration of SYS6010 and Enlonstobart | Approximately 13 months |
| Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) | Approximately 13 months |
| 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 |
|---|---|
| C000707970 | tislelizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| C000613593 | durvalumab |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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