Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Neoplasm Metastasis, Neoplastic Processes, Pathologic Processes, Lung Neoplasms, Lymphatic Metastasis
Brief summary
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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants (male or female) more than and equal to 18 years of age on the day of signing the ICF. * Disease status: Participants with completely resected, histologically- or cytologically-confirmed (Stage II or IIIA) NSCLC * Treatment with platinum-based chemotherapy; • Chemotherapy must have begun within 12 weeks after the resection surgery. The last chemotherapy dose must have been completed at least 3 weeks and no more than 12 weeks before the participant is randomized. * No evidence of disease (NSCLC) for the post-surgery baseline assessment must be documented by full chest/abdomen/pelvis computed tomography (CT) and/or magnetic resonance imaging (MRI) and brain CT/MRI within 12 weeks prior to the randomization date. * Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion criteria
* Surgical-related adverse events (AEs) or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade \<=2 alopecia, fatigue, neuropathy, and lack of appetite/nausea. * Participants who have received systemic corticosteroids (more than \[\>\] 10 mg prednisone daily or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or tumor necrosis factor alpha inhibitors) within 2 weeks prior to the first dose. * Participants with known epidermal growth factor receptor (EGFR)-sensitive mutations or anaplastic lymphoma kinase (ALK) gene translocations are not allowed. * Received prior therapy with an anticytotoxic T-lymphocyte antigen-4 mAb (example, ipilimumab); anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (Programmed Death-Ligand 1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor. * Participants with any active autoimmune disease or history of autoimmune diseases including but not limited to autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau,sd of QL2107 and Keytruda | At Cycle 1 (cycle length = 21 days)] | 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. |
| AUCtau,ss of QL2107 and Keytruda | At Cycle 7 (cycle length = 21 days)] | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ctrough of QL2107 and Keytruda | Up to Cycle 10 at Predose (cycle length = 21 days) | The trough serum concentration measured before the next dose is administered (Ctrough) of QL2107 and Keytruda® (predose samples) will be reported. |
| Cmax,sd of QL2107 and Keytruda | At Cycle 1 (cycle length = 21 days)] | Maximum (peak) serum concentration after a single dose (Cmax,sd) of QL2107 and Keytruda® will be reported. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Week 52 | — |
| Number of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Up to Week 52 | — |
| Cmax,ss of QL2107 and Keytruda | At Cycle 7 (cycle length = 21 days)] | Maximum (peak) serum concentration at steady state (Cmax,ss) of QL2107 and Keytruda® will be reported. |
Outcome results
None listed