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The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2107 | Experimental |
| |
| Keytruda® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2107 | Drug | 200mg on day 1 of each 21-day cycle of the study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| clinical equivalence | The 24-week objective response rate (24-week ORR, defined as the proportion of subjects who achieve CR or PR based on best efficacy at any time within 24 weeks after administration, evaluated according to RECIST 1.1) assessed by the Independent Review Committee (IRC) | 24-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu, PhD | Contact | 0531-67626971 | sdyujinming@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University Cancer Hospital | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pemetrexed |
| Drug |
500 mg/m2 on Day 1 of each 21-day cycle of the study |
|
| Carboplatin | Drug | Target AUC of 5 mg/mL/min on Day 1 of each 21-day cycle up to 4 cycles |
|
| Keytruda® | Drug | 200mg on day 1 of each 21-day cycle of the study |
|
| 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 |