Non-small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study; 2. PS > 2, lung cancer in the elderly (less than 65 years old); 3. subjects' characteristics and target disease characteristics histologically or cytologically diagnosed as NSCLC (SQ or NSQ) and with stage IIIB/IV tumors (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, Version 8) or multimodal therapy (radiotherapy, surgical resection) Subjects who relapsed or developed disease after radical chemoradiotherapy for locally advanced diseases; 4. Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment.
Exclusion criteria
Exclusion criteria: 1. Women with a positive pregnancy test at enrollment or prior to administration of study medication; 2. Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug; 3. Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period Participants with carcinomatous meningitis; 4. Other protocol defined inclusion/exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD-L1 expression levels;PD-L1 expression levels;tumor mutation burden;Serum cytokine levels;Immunotherapy efficacy; | — |
Countries
China
Contacts
State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University