Tiragolumab is a TIGIT fully humanized monoclonal antibody. TIGIT is an inhibitory receptor, is highly expressed in tumor-infiltrating T cells of a variety of cancer types, by competing with CD226 and binding to PVR, disrupting the activation of CD226 and other mechanisms, inhibiting T cells activation.
study drug: Tiragolumab injection (III s) test type
: Controlled Trials (VS Duvalizumab)
Test title: comparison of atilizumab combined with Tiragolumab versus non-platinum-containing regimens after radiochemotherapy phase III studies of patients with non-small cell lung cancer
indications: non-small cell lung cancer
inclusion criteria
1. Sign the informed consent form.
2. Age ≥18 years old when signing the informed consent.
3. ECOG physical fitness score is 0 or 1.
4. Histologically or cytologically confirmed with locally advanced, unresectable squamous or non-squamous histological stage III NSCLC.
5. Perform a whole-body positron emission tomography (PET)-CT scan 42 days before the first CRT in the same period.
6. Received at least 2 cycles of platinum-containing (globally approved) concurrent radiotherapy and chemotherapy (cCRT) treatments. These treatments must be completed within 1 to 42 days before randomization of the study.
7. The total radiation dose of the RT component in cCRT must be 60 (±10%) Gy (54 Gy to 66 Gy), using IMRT (preferred) or 3D conformal technology.
8. No progress during or after platinum-containing CRT during the same period.
9. The tumor has PD-L1 expression.
10. Life expectancy ≥ 12 weeks.
11. For women of fertility: consent to abstinence (prohibition of sexual intercourse with a male partner) or use the following contraceptive methods: women during treatment, within 90 days after the last dose of tiragolumab and atelizumab Anti-abstinence must be maintained within 5 months after the last administration or within 3 months after the last administration of duvalizumab or a contraceptive method with an annual failure rate of <1%>
For men: agree to abstinence (avoid heterosexual intercourse) or use condoms, and agree to avoid sperm donation, the specific rules are as follows: if the female partner is fertile or pregnant, the man must be during the treatment period and the last tiragolumab Keep abstinence or use condoms for 90 days after administration to prevent embryos from being exposed to the drug. Male patients are not allowed to donate sperm during this period.
Exclusion criteria
1. Any previous history of NSCLC.
2. NSCLC patients with known mutations in the EGFR gene or ALK fusion oncogene were excluded from the study.
3. There is any evidence of stage IV disease.
4. Use sequential CRT to treat locally advanced NSCLC.
5. Patients with locally advanced NSCLC who have progressed during or after CRT during the same period before randomization.
6. In the past, cCRT caused any unhealed toxicity >2.
7. Previous cCRT caused non-infectious pneumonia ≥2 grade.
8. Current or previous autoimmune disease or immunodeficiency.
9, idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans, or history of idiopathic pneumonia), Chest CT scan at screening showed evidence of active pneumonia.
10. There is a history of malignant tumors other than NSCLC within 5 years before screening.
11. Previously received allogeneic stem cell transplantation or solid organ transplantation.
12. The EBV virus capsid antigen IgM was positive during screening.
13. Received trial treatment within 28 days before starting study treatment.
14. Previous use of CD137 agonist or immune checkpoint blocking therapy, including anti-cytotoxic T lymphocyte-associated protein 4, anti-TIGIT, anti-PD-1 and anti-PD-L1 therapeutic antibodies.
15. When receiving any immunotherapeutic drugs other than immune checkpoint blockers, any ≥ grade 3 immune-mediated adverse events or any uncured> grade 1 immune-mediated adverse events Adverse events.
16, are pregnant or lactating, or intend to be during study treatment, or within 90 days after the last dose of tiragolumab, within 5 months after the last dose of atelizumab, or duvalib Get pregnant within 3 months after the last dose of eumab.
Research Center
Shandong Jinan, Qingdao
Zhejiang Wenzhou, Hangzhou _span_span0
Span1, Xiamen, Fujian span_p7sp5
Shantou, Guangzhou
Hubei Wuhan
Beijing
Tianjin
Zhengzhou, Luoyang_span_span0 5 Henan Span_span0, Luoyang_span5 _span5 0p after Chongqing Changsha Changchun Chengdu the specific circumstances of the start of consultation [Important Reminder] This official account [Global Good Medicine Information] All article information is for reference only.Specific treatment Please follow the doctor's advice !
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