advanced lung cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients volunteered to participate in this study and signed informed consent 2. Aged 18 to 75 years old; both men and women, ECOG PS score: 0 to 2 points; expected survival period >= 12 weeks; 3. Pathological or cytological diagnosis is NSCLC, clinical stage is stage IIIa-IV; 4. Patients with sensitive EGFR mutations or ALK translocations must be treated with one or more approved targeted drugs to treat disease progression or intolerance; 5. Previously patients who have not received systematic anti-tumor treatment, including systemic radiation and chemotherapy, targeting and immunotherapy; 6. Tissue samples should be provided for biomarker (eg PD-L1) analysis, preferably newly acquired tissues. Patients who are unable to provide newly acquired tissues can provide archived 3-5 µm thick paraffin sections 5-8 sheets. 7. The main organ function meets the following criteria within 7 days before treatment: (1) Blood routine examination criteria (without blood transfusion within 14 days): 1) hemoglobin (HB) >= 90g / L; 2) neutrophil absolute value (ANC) >= 1.5 x 10^9 / L; 3) platelets (PLT) >= 80 x 10^9 / L. (2) Biochemical examinations must meet the following criteria: 1) total bilirubin (TBIL) = 60ml / min; 4) serum albumin >= 35g / L. (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= normal low limit (50%).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of immunodeficiency or study of systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose, allowing the use of physiological doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) Drug; 2. Exclude subjects with active, known or suspected autoimmune diseases; 3. Patients with brain metastases with symptoms or symptoms controlled for less than 2 months; 4. Patients with heart disease, cardiac insufficiency or abnormal electrocardiogram; 5. Patients with acute or chronic infectious diseases and infectious diseases; 6. patients with recent bleeding history; 7. The investigator believes that patients are not eligible to participate in other situations in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Remission;Partial Remission;Stable disease;Disease Progression;Median progression-free survival;Median overall survival; | — |
Countries
China
Contacts
Department of Oncology, the Second People's Hospital of Yibin City