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This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC
This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose level 1 of SSGJ-706 monotherapy | Experimental |
| |
| dose level 2 of SSGJ-706 monotherapy | Experimental |
| |
| dose level 1 of SSGJ-706 combined with chemotherapy | Experimental |
| |
| dose level 2 of SSGJ-706 combined with chemotherapy | Experimental |
| |
| PD-1/L1 combined with chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-706 | Drug | PD-1/PD-L1 bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 12 months | |
| Incidence and severity of Adverse Events | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR : Disease Control Rate | 12 months | |
| PFS:Progression-Free Survival | 24 month | |
| OS:Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengxiang Ren | Contact | 13816756732 | harry_ren@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of The Shanghai Pulmonary Hospital | Recruiting | Shanghai | China |
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| pemetrexed /carboplatin | Drug | chemotherapy |
|
| Carboplatin/Paclitaxel | Drug | chemotherapy |
|
| PD-1 Inhibitor + Chemotherapy | Drug | control group |
|
| 24 month |
| The blood concentration of SSGJ-706 | Approximately 6 months |
| The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab) | Approximately 6 months |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| C053518 | CP protocol |
| D000082082 | Immune Checkpoint Inhibitors |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D013812 | Therapeutics |
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