Squamous cell carcinoma of lung
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Histologically proven stage IIIB/C and IV squamous cell carcinoma (SCC) not suitable for surgery or local therapy; 3. EGFR sensitive mutation and ALK or ROS-1 gene rearrangement were not detected; 4. There are tumor tissue samples available for PD-L1 immunohistochemical examination; 5. The investigator has at least one measurable lesion confirmed by the RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. Patients who have received neoadjuvant chemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy for non-metastatic disease, the interval from the end of the last treatment is at least 6 months, and they have not received systemic anti-tumor therapy after being diagnosed with advanced lung cancer; 8. The main organs function normally; 9. Expected survival time >= 3 months.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system metastasis or meningeal metastasis; 2. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug, or another drug that stimulates or synergistically inhibits T-cell receptors (eg: CTLA-4, OX-40, CD137); 3. There is clinically uncontrollable pleural effusion/peritoneal effusion; 4. Currently participating in interventional clinical research treatment, or receiving other drugs or using research equipment after diagnosis of advanced lung cancer; 5. Active autoimmune disease requiring systemic treatment occurred within 2 years before the first administration; 6. There is any serious or uncontrollable systemic disease; 7. Received >30Gy of pulmonary radiation therapy within 1 month before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overal survival;Disease control rate; | — |
Countries
China
Contacts
Cancer Hospital of Chinese Academy of Medical Sciences