Non small cell lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=18, male or female, sign informed consent form (ICF); 2. Stage IIIB or IV of advanced NSCLC, AJCC (7th Edition) standard in pathology or clinical diagnosis; 3. ECOG PS=1 measurable lesion; 5. Life expectancy >=12 weeks; 6. The researchers judged that the subjects had sufficient organ function; 7. Effective contraception.
Exclusion criteria
Exclusion criteria: 1. EGFR mutation or ALK gene rearrangement but not treated with EGFR or ALK inhibitors; 2. Received PD-1 or PD-L1 therapy; 3. Glucocorticoid (> 10mg / day of prednisone) or other immunosuppressive drugs were used in the whole body within 14 days before the first administration; 4. History of pulmonary interstitial disease; 5. Clinically significant pericardial effusion; 6. Severe active infection, active or uncontrolled pial disease, untreated brain metastasis; 7. Active or refractory infectious diseases, including HIV infection; 8. Participants with untreated hepatitis B virus (HBV) / hepatitis C virus; 9. At the same time, patients with other malignant tumors who cannot benefit from the treatment of this study were judged by the researchers; 10. According to the judgment of the researcher, it is not suitable for the patients in this study group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment emergent adverse events (TEAEs);Overall Response Rate, ORR;Disease Control Rate, DCR;Duration Of Remission, DOR;Progression Free Survival, PFS;Time To Failure, TTF; | — |
Contacts
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