non-small cell lung cancer
Conditions
Interventions
Group 1 of immunotherapy:ICIs monotherapy
Group 2 of immunotherapy:Combination with chemotherapy
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old and = 10mm by CT scan, a lymph node must be >= 15 mm in short axis when assessed by CT scan, and the thickness of the scan layer is not greater than 5mm. The measurable lesions have not received local therapy such as radiotherapy or cryotherapy; 6. ECOG score 0-2; 7. The expected survival time is not less than 3 months; 8. Adequate vital organ function (hematology, liver and kidney function, etc.); 9. Patients are willing to provide blood and tumor tissue samples according to the study design; 10. Patients must join the study voluntarily and sign written informed consents before any trial-related procedures, and they should be cooperated with treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or other drugs that stimulate or synergistically inhibit T cell receptors (for example, CTLA4, OX-40, CD137); 2. Known to have allergic reactions to immune checkpoint inhibitors and active ingredients of chemotherapeutic drugs used in the research and or any auxiliary materials; 3. Patients who need long-term systemic use of corticosteroids. Patients who require intermittent use of bronchodilators, inhaled corticosteroids, or local injections of corticosteroids due to COPD and asthma can be included in the group; 4. Known mental illness or drug abuse that may affect compliance with the test requirements; 5. There is a medical history, disease, treatment or abnormal laboratory results that may interfere with the test results and prevent the subject from participating in the research, or the researcher believes that participating in the research is not in the subject's best interests; 6. Local or systemic diseases caused by non-malignant tumors, or secondary reactions of cancer, which may lead to higher medical risks and/or uncertainty in survival evaluation; 7. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;overall survival;objective release rate; | — |
Countries
China
Contacts
Public ContactSu Chunxia
Shanghai Pulmonary Hospital
Outcome results
None listed