Advanced non-small cell lung cancer
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients must voluntarily participate in this study and sign the informed consent; 2.Histologically confirmed patients with advanced non-small cell lung cancer; 3.Aged >= 18 years; 4.Measurable tumor lesions according to RECIST 1.1; 5.ECOG PS: 0-2 marks; 6.Function of vital organs is normal; 7.Expected survival >= 3 months; 8.No positive EGFR or ALK mutation.
Exclusion criteria
Exclusion criteria: 1.Previous or concurrent malignancies, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 2.Patients who have already started radiotherapy and patients who are highly allergic to any study drug or excipient; 3.Active tuberculosis infection; 4.Patients who have an active, known or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment). Subjects with hypothyroidism that require only hormone replacement therapy and skin disorders that require no systemic treatment (such as vitiligo, psoriasis, or alopecia) are eligible for inclusion; 5.Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac dysfunction, and poorly controlled arrhythmia (including QTcF interphase male & GT; 450 ms, Female & GT; 470 ms, QTcF interval calculated by the Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 6.Patients receiving hematopoietic stem cells or organ transplants; 7.Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 8.A history of psychotropic substance abuse, alcohol abuse or drug abuse; 9. Pregnant or lactating women; 10.The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Affiliated Cancer Hospital of Harbin Medical University