advanced non-small cell lung cancer
Conditions
Interventions
Group A:6 cycles of immunotherapy combined with chemotherapy, followed by 1 cycle of palliative radiotherapy. Alternatively, 2 cycles of immunotherapy combined with chemotherapy, followed by 1 cycle
Sponsors
Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Non-small cell lung cancer, confirmed by pathology; No EGFR/ALK gene mutation;PD-L1 TPS expression was not limited (less than 1% of patients did not exceed 20% of the total sample size); (2) Patients with stage IV clinical staging (TNM staging system) and oligometastases (less than 5 metastatic lesions) (which can contain no more than 10% of the total sample size of asymptomatic or stable brain metastases after treatment); ? Patients who have not been treated for lung cancer before; (4) Patients between 18 and 75 years old, male and female; (5) Patients can understand the informed consent, participate in and sign the informed consent voluntarily as well; ? At least 1 measurable lesion (according to RECIST V1.1 for solid tumor efficacy evaluation); ? Performance score of 0 or 1 (the Eastern Oncology Consortium ECOG scoring system); ? Life expectancy of at least six months; (9) Have sufficient functions to the organs: a. Bone marrow function: hemoglobin =100 g/L (did not receive blood transfusion within 28 days before hemoglobin test), neutrophil absolute count =1.5×10^9/L, platelet count =100×10^9/L (did not receive platelet transfusion or IL-11 treatment within 14 days before platelet count test); b. Coagulation function: International Standardized ratio (INR) or prothrombin time (PT) < 1.5× upper normal limit (ULN), activated partial thrombin time (APTT) < 1.5×ULN; c. Liver function: transaminase (ALT and AST) =2.5×ULN; Total bilirubin =1.5×ULN (total bilirubin =2.5×ULN in subjects with Gilbert's syndrome or liver metastasis); d. Renal function: serum creatinine clearance =60 mL/min (calculated by Cockcroft-Gault formula); (10) In fertile female patients, serum pregnancy tests must be negative for seven days before first administration. (11) Fertile female patients or male patients whose partners are fertile agree to use effective birth control (with an annual failure rate of less than 1%) starting 7 days before the first dose until 24 weeks after the end of all treatment.
Exclusion criteria
Exclusion criteria: (1) Major surgery (such as abdominal, thoracic and other major surgery) was received within 28 days before administration; Excluding diagnostic puncture or peripheral vascular access replacement) or patients who have not recovered from surgical treatment; (2) Systemic corticosteroids (=10 mg/ day, prednisone, or equivalent corticosteroids) or immunosuppressant therapy were required for 7 consecutive days within 14 days prior to the first administration of this study; Except inhaled or topical use of hormones, or physiological replacement dose of hormone therapy for adrenal insufficiency; Allow short-term (< 7 days) corticosteroids for the prevention (e.g., contrast media allergy) or the treatment of non-autoimmune conditions (e.g., delayed hypersensitivity caused by exposure to allergens); (3) Received live vaccine (including attenuated live vaccine) within 28 days prior to administration in this study; (4) Past or current history of interstitial lung disease requiring systemic hormonal therapy; (5) Have or currently have an autoimmune disease, Including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatous disease with multiple vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis, ophthalmochromatitis), autoimmune hepatitis, systemic scleroderma (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, Autoimmune neuropathy (Guillain-Barre syndrome), etc. The following conditions are excluded: Type I diabetes, hypothyroidism stable with hormone replacement therapy (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo that do not require systemic therapy; ? Other malignancies within 5 years prior to initial administration, except cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscular invasive bladder carcinoma, localized low-risk prostate (defined as stage =T2a, Gleason score =6), and PSA=10ng/mL at the time of diagnosis of prostate cancer (as measured, Patients who had received radical treatment without PSA biochemical recurrence could participate in this study), cervical/breast cancer in situ; He has uncontrolled complications of heart, kidney, gastrointestinal and infectious diseases. ? History of allogeneic bone marrow or organ transplantation; (9) dramatic reactions to drugs (such as severe allergic reactions, immunomediated hepatotoxicity, immunomediated thrombocytopenia, anemia); (10) Pregnant and/or lactating women; (11)Active tuberculosis; (12) Any other conditions that will affect the safety or compliance of treatment in the study, including but not limited to mental illness, uncontrolled large amounts of serous effusion, or medium to large amounts of serous effusion requiring repeated drainage (recurrence within 2 weeks after intervention), and acidosis; (13) The presence of contraindications in the use of the study drug, any other diseases, metabolic disorders, abnormalities in physical examination, or clinical laboratory abnormalities that might affect the interpretation of the results or the treatment complications that might place the patient at high risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Time To New Metastasis; | — |
Countries
People's Republic of China
Contacts
Public ContactXiaomei Gong
Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, People's Republic of China
Outcome results
None listed