Phase
Condition
Neoplasm Metastasis
Lung Cancer
Recurrent Respiratory Papillomatosis
Treatment
Keytruda®
QL2107
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult participants (male or female) more than and equal to 18 years of age on theday of signing the ICF.
Disease status: Participants with completely resected, histologically- orcytologically-confirmed (Stage II or IIIA) NSCLC
Treatment with platinum-based chemotherapy; • Chemotherapy must have begun within 12weeks after the resection surgery. The last chemotherapy dose must have beencompleted at least 3 weeks and no more than 12 weeks before the participant israndomized.
No evidence of disease (NSCLC) for the post-surgery baseline assessment must bedocumented by full chest/abdomen/pelvis computed tomography (CT) and/or magneticresonance imaging (MRI) and brain CT/MRI within 12 weeks prior to the randomizationdate.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Exclusion
Exclusion Criteria:
Surgical-related adverse events (AEs) or chemotherapy-related toxicity not resolvedto Grade 1, with the exception of Grade <=2 alopecia, fatigue, neuropathy, and lackof appetite/nausea.
Participants who have received systemic corticosteroids (more than [>] 10 mgprednisone daily or equivalent) or other immunosuppressive drugs (such ascyclophosphamide, azathioprine, methotrexate, thalidomide, or tumor necrosis factoralpha inhibitors) within 2 weeks prior to the first dose.
Participants with known epidermal growth factor receptor (EGFR)-sensitive mutationsor 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 diseasesincluding but not limited to autoimmune hepatitis, interstitial pneumonia, pulmonaryfibrosis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism,and hypothyroidism.