Non-squamous cell non-small cell lung cancer
Conditions
Interventions
experimental group:Cindilizumab +PP/PC combined with CyberKnife sequential cindilizumab
Sponsors
Oncology Department of the sixth medical center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects who signed the written informed consent before the implementation of any test related process; 2. Subjects aged >= 18 and = 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, hemoglobin >= 90g / L [no blood transfusion or EPO dependence within 7 days]; 10. Subjects with good liver function were defined as total bilirubin level = 60ml / min (Cockcroft Gault formula); Urine routine examination showed that urine protein was less than 2 +, or 24-hour urine protein was less than 1G; 12. Subjects with good coagulation function were defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN If the subject is receiving anticoagulant therapy, as long as Pt is within the scope of anticoagulant drugs; 13. For women of childbearing age, the subjects should be negative in urine or serum pregnancy test within 3 days before receiving the first study drug administration (cycle 1, day 1). If the result of urine pregnancy test can not be confirmed as negative, blood pregnancy test is required; 14. If there is a risk of pregnancy, male and female patients need to use effective contraception (i.e. the annual failure rate is less than 1%) and continue to use it for at least 180 days after the trial treatment is stopped.
Exclusion criteria
Exclusion criteria: 1. Patients with NSCLC mainly composed of squamous cells; The mixed cell type must be dominated by adenocarcinoma cells (= 90%); If there is small cell type, the subject can not be included in the group; 2. Subjects enrolled in another clinical study at the same time, except for the observational (non intervention) clinical study or the follow-up stage of the intervention study. Participated in another clinical study and received IP administration in the last 4 weeks, is currently participating in the treatment of intervention clinical study, or received other research drugs or used research instruments in the first 4 weeks before administration; 3. Subjects who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or drugs that stimulate or co inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. The subjects who received Chinese patent medicine with anti lung cancer indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration received systemic treatment, or received severe surgery within 3 weeks before the first administration; 5. Patients with history of chest radiotherapy before systemic therapy. Radiotherapy outside the chest (i.e., bone metastases) for palliative purposes is permitted, but it must be completed before the first administration of the study drug. 6. Patients with clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 7. Patients who have received solid organ or blood system transplantation; 8. Patients with clinically uncontrollable pleural effusion / peritoneal effusion (patients who do not need drainage or whose effusion does not increase significantly after 3 days of drainage can be included in the group); 9. Subjects with known severe allergic reactions (>= grade 3) to sindilimab, pemetrexed, cisplatin, carboplatin, their active ingredients and any excipients; 10. Active autoimmune diseases occurred in patients requiring systemic treatment (e.g. using disease relief drugs, corticosteroids or immunosuppressants) within 2 years before the first administration. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic; 11. Subjects diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Physiological dose of Glucocorticoid (<= 10 mg / day of prednisone or equivalent) was allowed; 12. Patients who have not fully recovered from the toxicity and / or complications caused by any intervention before the start of treatment (i.e., <= grade 1 or reaching baseline, excluding fatigue or hair loss); 13. Patients diagnosed with other malignancies within 5 years before the first administration, with the exception of radical basal cell carcinoma of skin, squamous cell carcinoma of skin and / or radical resection of carcinoma in situ; 14. Symptomatic central nervous system metastasis. Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases can participate in this study as long as all the following criteria are met: there are measurable lesions outside the central nervous system; No meninges, midbrain, pons, medulla oblongata or spinal cord metastases were found; Ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;QOL, Health related quality of life;ORR;TTP; | — |
Countries
china
Contacts
Public ContactYang Jihua
Oncology Department of the Sixth Medical Center of PLA General Hospital
Outcome results
None listed