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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519883-42-00 | EU Trial (CTIS) Number |
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The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2107 200mg | Experimental | Participants will receive QL2107 200 milligrams (mg) intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 days treatment cycle for up to 17 treatment cycles. |
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| Keytruda® 200 mg | Active Comparator | Participants will receive Keytruda® 200 mg IV infusion Q3W, on Day 1 of each 21- days treatment cycle for up to 17 treatment cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2107 | Drug | IV infusion. |
| |
| Keytruda® |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,sd of QL2107 and Keytruda | Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single initial) dose (AUCtau,sd) of QL2107 and Keytruda® will be reported. | At Cycle 1 (cycle length = 21 days)] |
| AUCtau,ss of QL2107 and Keytruda | Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUCtau,ss) of QL2107 and Keytruda® will be reported. | At Cycle 7 (cycle length = 21 days)] |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,sd of QL2107 and Keytruda | Maximum (peak) serum concentration after a single dose (Cmax,sd) of QL2107 and Keytruda® will be reported. | At Cycle 1 (cycle length = 21 days)] |
| Cmax,ss of QL2107 and Keytruda |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D008175 | Lung Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Drug |
IV infusion. |
|
Maximum (peak) serum concentration at steady state (Cmax,ss) of QL2107 and Keytruda® will be reported.
| At Cycle 7 (cycle length = 21 days)] |
| Ctrough of QL2107 and Keytruda | The trough serum concentration measured before the next dose is administered (Ctrough) of QL2107 and Keytruda® (predose samples) will be reported. | Up to Cycle 10 at Predose (cycle length = 21 days) |
| Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Up to Week 52 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 52 |