lung cancer
Conditions
Interventions
Group A:Stereotactic radiotherapy with tomo: GTV 60Gy / 20 times
Group B:Stereotactic radiotherapy with tomo: GTV 60Gy / 30 times
Sponsors
Air Force Specialty Medical Center, PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.They are willing to participate in the clinical study, fully understand and know the study and sign the master ICF (informed consent); 2.At the date of signing ICF, the age was over 18 years old; 3.Histologically or cytologically confirmed locally advanced unresectable stage III non-small cell lung cancer (according to the 8th edition of the international society for the study of lung cancer (IASLC), Non squamous cell carcinoma: (1) Epidermal growth factor receptor (EGFR) mutation: subjects with known EGFR mutation need to be excluded (the detection method and results are approved by the research center and the sponsor, and the method conforming to NCCN or CSCO guidelines is recommended); subjects with unknown EGFR mutation status must be detected by the experimental method approved by our unit, if EGFR mutations were excluded. (2) For anaplastic lymphoma kinase (ALK) translocation and c-ros sarcoma carcinogen 1-receptor tyrosine kinase (ros1) translocation: subjects with known ALK and ros1 translocation need to be excluded; subjects with unknown ALK and ros1 translocation must be detected by the experimental method approved by our unit. If there is ALK and ros1 translocation, the subjects will be excluded. Squamous cell carcinoma: (3) Subjects with known EGFR mutation, ALK translocation and ros1 translocation are excluded; subjects with unknown conditions need to be detected and must be detected by the experimental method approved by our unit. If EGFR mutation, ALK and ros1 translocation exist, the subjects are excluded. 4.In the past 4 weeks, he did not receive any other anti-tumor drugs other than the experimental drugs, and was able to receive specialized anti-tumor treatment; 5.ECOG score was 0 or 1; 6.Life expectancy >= 12 weeks; 7.Provide unstained tumor tissue sections for TMB analysis and provide relevant pathological reports. If there is no archived tumor tissue sample, the subjects are willing to perform tumor biopsy before the study treatment to obtain corresponding tumor samples (the number of samples to be obtained depends on the biopsy situation). If the subject is unable to carry out the tumor biopsy due to medical reasons, it needs to be discussed in our center; 8.Except for hearing loss, alopecia and fatigue, all toxicity caused by previous anti-tumor treatment must have recovered to = 3000 / µL, absolute count of neutrophil (ANC) >= 1500 / µL, platelet >= 100000 / µL, hemoglobin >= 9.0g/dL; AST and ALT <= 2.5 times the upper limit of normal (ULN), ALP <= 4 times the upper limit of normal, TBIL <= 1.5 times the upper limit of normal; Serum creatinine <= 1.5 times of ULN, blood urea nitrogen (BUN) <= 2.5 times of ULN; International normalized ratio of prothrombin time or partial thromboplastin time <= 1.5 times of ULN; The left ventricular ejection fraction (LVEF) was greater than or equal to 60% as assessed by Doppler ultrasound. 10.Fertile men and women of childbearing age must agree to take effective contraceptive measures from signing the master informed consent to 180 days after the last treatment of the study; Women of c
Exclusion criteria
Exclusion criteria: 1.The histology was identified as a mixed small cell lung cancer component; 2.The disease progression occurred after receiving synchronous / sequential radiotherapy and chemotherapy; 3.Major surgery was performed within 28 days before the study; 4.The study drug was vaccinated with live vaccine within 28 days before the first administration; 5.The study used the Chinese medicine with anti-tumor indications within 14 days before the first drug administration; 6.The study drug was given 28 days before the first administration of the study drug and participated in any other clinical trial or was undergoing other clinical trials; 7.They were treated with any antibodies / drugs targeting T-cell co regulatory proteins (Immune checkpoint), including PD-1, PD-L1, CTLA4, TIM3 and LAG3; 8.Have active, or have had and are likely to recur, autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.) or have such risks (such as immunosuppressive treatment for organ transplantation). But subjects with the following diseases were allowed to be further screened: type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disease without systemic treatment (such as vitiligo, psoriasis or hair loss), or the condition is not expected to recur without external triggers; 9.Systemic hormone therapy (e.g., hormone therapy equivalent to a daily dose of prednisone of more than 10mg per day) or any other form of immunosuppression therapy was used within 7 days prior to diagnosis of immunodeficiency or the first administration. If the subjects did not have active autoimmune disease, hormone equivalent to or less than 10mg prednisone per day was allowed as adrenal replacement therapy; Subjects were allowed to use local, eye, intraarticular, intranasal and inhaled glucocorticoids (very low systemic absorption); Short-term glucocorticoids are allowed to prevent (for example, for contrast agent allergies) or for non autoimmune diseases (e.g. late hypersensitivity due to contrast agent allergies); 10.Other primary malignant tumors occurred within 5 years before the first administration of the study drug, except for locally curable tumors treated with radical treatment (except for basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ); 11.Patients with interstitial lung disease and symptoms; subjects who believe that previous lung history may interfere with the judgment or treatment of drug-related pulmonary toxicity need to be excluded; 12.There was a history of active tuberculosis infection within 1 year before the treatment of the study; if the subjects with active tuberculosis infection more than one year ago were judged by the researchers that there is no evidence of active tuberculosis, they would be considered suitable for the group; 13.Has a history of inflammatory enteritis or is currently suffering from inflammatory bowel disease (such as Crohn's disease and ulcerative colitis); 14.Patients with a known history of human immunodeficiency virus (HIV) infection and / or acquired immunodeficiency syndrome; 15.Subjects with active or active hepatitis C. The subjects with HBsAg or HCV antibody positive in screening stage must further pass the quantitative detection of HBV DNA (excluding more than 2500 copies / mL or 500iu / mL) and HCV RNA detection (excluding the lower l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactLi Hongqi
Air Force Specialty Medical Center, PLA
Outcome results
None listed