Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of NSCLC

Prior treatment

• Surgical-related AEs or chemotherapy-related toxicity not resolved to Grade 1, with the exception of Grade ≤2 alopecia, fatigue, neuropathy, and lack of appetite/nausea.
• Subjects who have received systemic corticosteroids (>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. Note: Inhaled or topical steroids and adrenal replacement steroids are permitted in the absence of an active autoimmune disorder.
• Prior or planned neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy for the current malignancy.

Lab values

• 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 anticytotoxic T-lymphocyte antigen-4 monoclonal antibody (eg, ipilimumab), anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent; or agent directed to another stimulatory or co-inhibitory T cell receptor.

• 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) ≥ 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 PD-L1 status. Patients should provide PD-L1 reports or provide archived or fresh tissue samples for PD-L1 tests which may be performed locally or in central laboratory. A tumor tissue sample obtained at surgical rection 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.