Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: QL2107: Dose - 200 mg pembrolizumab per cycle
Frequency - Once every 3 weeks (Q3W) for up to 17 cycles
Route of Administration - Intravenous infusion
Total Duration of Treatment- Appro
Sponsors
Qilu Pharmaceutical Co., Ltd.
Syneos Health India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who voluntarily participate have read understood and signed the informed consent form and are able to comply with the study procedures. Adult subjects male or female more than equal to 18 years of age on the day of signing the informed consent form. Disease status Subjects with completely resected histologically or cytologically confirmed Stage II or IIIA NSCLC as per the American Joint Committee on Cancer Eighth Edition. Complete resection R0 is achieved when resection margins are free systematic or lobe specific nodal dissection has been performed the highest lymph node station harvested is negative and there is no extracapsular nodal involvement. Patients will be eligible to participate regardless of the level of PDL1 status. Patients should provide PDL1 reports or provide archived or fresh tissue samples for PDL1 tests which may be performed locally or in central laboratory. A tumor tissue sample obtained at surgical resection is preferred. Tumor samples obtained before NSCLC surgery are allowed only if the most recent biopsy tumor sample cannot be collected. 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 subject 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
Exclusion criteria: Surgical related adverse events or chemotherapy related toxicity not resolved to Grade One with the exception of Grade Two or less alopecia fatigue neuropathy and lack of appetite or nausea. Subjects who have received systemic corticosteroids greater than ten milligrams prednisone daily or equivalent or other immunosuppressive drugs such as cyclophosphamide azathioprine methotrexate thalidomide or tumor necrosis factor alpha inhibitors within two weeks prior to the first dose. Note Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of an active autoimmune disorder. Subjects with known epidermal growth factor receptor EGFR sensitive mutations or anaplastic lymphoma kinase ALK gene translocations are not allowed. Subjects must provide EGFR and ALK reports from previous histological or cytological tests. If no prior EGFR or ALK test has been performed archived tissue samples should be provided for EGFR and ALK tests which may be performed. Received prior therapy with an anti cytotoxic T lymphocyte antigen four monoclonal antibody for example ipilimumab anti programmed cell death one PD One anti programmed cell death ligand one PD L One or anti programmed cell death ligand two PD L Two agent or agent directed to another stimulatory or co inhibitory T cell receptor. Prior or planned neoadjuvant or adjuvant radiotherapy and or neoadjuvant chemotherapy for the current malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate PK similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda Timepoint: Week 1 Week 19-22 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the maximum (peak) serum concentrations after the initial dose and at steady state as well as serum trough concentrations of QL2107 compared with Keytruda Timepoint: Week 1 Week 19 Week 4, 10, 13, 16, 19 and 28 | — |
Countries
Bosnia and Herzegovina, China, Georgia, Greece, Hungary, India, Jordan, Poland, Romania, Spain, Thailand, Turkey, Ukraine, Viet Nam
Contacts
Public ContactAtaur Rahman
Syneos Health India private Limited
Outcome results
None listed