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Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Active Comparator |
| |
| Treatment group C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin | Drug | Adebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Objective Response Rate (Phase One) | about 3 years | |
| Overall Survival (Phase Two) | about 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of Adverse Events (AEs) (Phases One and Two) | about 4.5 years | |
| Duration of Response (DoR) based on Investigator Assessment (Phases One and Two) | about 6.5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junli Qang | Contact | +0518-81220121 | Junli.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Tumor Hospital of Shandong First Medical University | Jinan | Shandong | 250117 | China |
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| Camrelizumab + Pemetrexed + Carboplatin | Drug | Camrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min |
|
| Adebrelimab + Pemetrexed + Carboplatin | Drug | Adebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min |
|
| Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two) |
| about 6.5 years |
| Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two) | about 6.5 years |
| Overall Survival (OS) (Phase One) | about 3.5 years |
| Objective Response Rate (ORR) based on Investigator Assessment (Phase Two) | about 4.5 years |
| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| C000631724 | camrelizumab |
| 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 |
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