Lung squamous cell carcinoma
Conditions
Interventions
Experimental group:The subjects in the experimental group received radiotherapy. Sintilimab combined with standard platinum-containing double-drug chemotherapy was performed within 1 week after the en
Control group:Subjects in the control group will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. The patient subsequently received maintenance tr
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any testing related processes; 2. Aged 18-75 years old; 3. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV) (TNM lung cancer staging, 8th edition of the International Association for Lung Cancer Research and the Joint Committee on Cancer Classification of the United States); 4. Provide sufficient quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression (TPS, antibody E1L3N); 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1 version), there should be at least one imaging measurable lesion. Lesions located within the previous radiation irradiation field can be considered measurable if confirmed to have progressed; 6. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past; 7. Allow asymptomatic or asymptomatic brain metastasis patients with stable symptoms after local treatment to be included, as long as the patient meets the following conditions: (1) Measurable lesions outside the central nervous system; (2) No central nervous system symptoms, or no worsening of symptoms for at least 2 weeks; (3) Those who do not require glucocorticoid treatment or discontinue glucocorticoid treatment within 7 days before the first study drug administration; 8. Subjects are allowed to receive palliative radiation therapy (including brain radiotherapy for symptomatic brain metastases and radiotherapy for bone metastases), but the radiotherapy must be completed at least 1 week before enrollment, and the toxicity related to radiotherapy should be restored to less than or equal to 1 degree (CTCAE 5.0, excluding hair loss); 9. ECOG score 0-1 points; 10. Expected survival time>6 months; 11. Adequate organ function is required for the subject to meet the following laboratory indicators: (1) In the past 14 days without the use of granulocyte colony stimulating factor, the absolute value of neutrophils (ANC) >= 1.5x10^9/L; (2) Platelets >= 100x10^9/L without blood transfusion in the past 14 days ; (3) In the absence of blood transfusion or use of erythropoietin within the past 14 days, hemoglobin>9g/dL; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international standardized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) The myocardial enzyme spectrum is within the normal range (if the researcher comprehensively determines that a simple laboratory abnormality without clinical significance is also allowed to be included); 12. Patients who have no contraindications to radiotherapy as determined by the radiologist; 13. For female subjects of childbearing age, they should undergo a urine or serum pregnancy test with a negative result within 3 days before receiving the firs
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC; 2. Pathologically, it is lung adenocarcinoma, including lung cancer mixed with lung squamous cell carcinoma; 3. EGFR gene sensitive mutations or ALK fusion positive or ROS1 fusion positive; 4. Subjects with a tendency to bleed evaluated by researchers for cavitary squamous cell carcinoma or imaging findings indicating invasion/infiltration of large blood vessels; 5. Active hemoptysis (at least 1/2 teaspoon of fresh blood) within 2 weeks prior to the first study drug administration; 6. Prior to the administration of the first study drug, radiation therapy was received and one of the following conditions was met: (1) Within 14 days prior to treatment, >= 30% of the bone marrow had undergone radiation therapy; (2) Received radiation therapy for lung lesions within 6 weeks prior to treatment with a dose > 30Gy (enrolled subjects must recover to level 1 or below from previous radiation toxicity, do not require glucocorticoid treatment, and have no history of radiation pneumonia); (3) The end time of palliative radiotherapy is within 7 days before the first study drug administration; 7. Received major surgical treatment within 3 weeks of the first study drug administration (excluding surgery for biopsy purposes); 8. Diagnosed as other malignant diseases other than NSCLC within 5 years prior to the first administration (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection); 9. Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 10. Previously received the following therapies: anti PD-1, anti PD-L1, or anti PD-L2 drugs, or drugs targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137); 11. Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 12. Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred within 2 years prior to the first administration. Alternative therapy (such as thyroxine, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) is not considered systemic treatment; 13. Within 7 days prior to the first administration of the study, the patient is receiving systemic glucocorticoid therapy (excluding local glucocorticoids administered through nasal spray, inhalation, or other means) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (<= 10mg/day of prednisone or equivalent) are allowed to be used; 14. Patients with clinically uncontrollable pleural/abdominal effusion (those who do not require drainage of the effusion or do not have a significant increase in effusion after stopping drainage for 3 days can be enrolled); 15. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 16. Individuals who are known to be allergic to active ingredients or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Explore the correlation between oral microbiome test results and efficacy.; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;disease control rate;duration of remission;6-month PFS rate;1-year PFS rate;Overall survival;The incidence of adverse events and severe adverse events;The incidence of AE/SAE leading to treatment termination; | — |
Countries
China
Contacts
Public ContactJianxin Xue/ You Lu
West China Hospital of Sichuan University
Outcome results
None listed