non-small cell lung cancer (NSCLC)
Conditions
Interventions
Experimental group:Sintilimab combined with platinum-based doublet chemotherapy
Sponsors
Qiqihar First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18-75 years; 3. Histologically or cytologically confirmed NSCLC, locally advanced stage IIIB/IIIC, metastatic or recurrent stage IV subjects (International Association for the Study of Lung Cancer and American Joint Committee on Cancer Classification 8th Edition TNM lung cancer stage), subjects who have not received systemic therapy in the past; subjects with visible solid tumors in the lumen of bronchoscopy; 4. Histological specimens are confirmed to be unsuitable for targeted therapy (non-squamous cell carcinoma subjects must be confirmed to have no EGFR gene sensitive mutation, ALK gene or ROS1 gene fusion mutation); 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion that can be measured by imaging. Lesions located in the field of previous radiotherapy can be regarded as measurable lesions if they are confirmed to have progressed; 6. Have not received any systemic antitumor therapy for advanced/metastatic disease before. For subjects who have received platinum-containing adjuvant/neoadjuvant chemotherapy, or subjects who have received radical chemoradiotherapy for advanced disease, such as disease progression or recurrence and the end of the last chemotherapeutic drug treatment interval at least 6 months, are allowed to be enrolled in this study; 7. Subjects with asymptomatic or stable brain metastases after local treatment are allowed to enroll, as long as the subjects meet the following conditions: (1) Measurable lesions outside the central nervous system; (2) No central nervous system symptoms or no exacerbation of symptoms for at least 2 weeks; (3) No need for glucocorticoid therapy, or discontinuation of glucocorticoid therapy within 7 days before the first dose, or the glucocorticoid dosage is stable and reduced to less than 10 mg/day prednisone (or equivalent dosage) within 7 days before the first administration; 8. Subjects are allowed to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), but radiotherapy needs to end at least 1 week before the first dose, and radiotherapy-related toxicity recovered to less than or equal to grade 1 (CTCAE 5.0, except for alopecia); 9. ECOG score 0-1 points; 10. Expected survival time > 3 months; 11. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >=1.5x10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelets >=100x10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin>9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, 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) Myocardial enzyme
Exclusion criteria
Exclusion criteria: 1. The general state is extremely weak and cannot tolerate bronchoscopy; 2. Patients with laryngeal tuberculosis, cervical spine metastasis or aortic aneurysm; 3. Those who are allergic to anesthetic drugs and cannot be replaced by other drugs; 4. Those with acute suppurative inflammation of the respiratory tract with high fever, acute asthma attack and hemoptysis; 5. Received radiation therapy before the first study drug administration, and one of the following conditions: (1) >= 30% of the bone marrow has received radiotherapy within 14 days before treatment; (2) Received radiotherapy for lung lesions within 6 weeks before treatment with a dose > 30Gy (Enrolled patients must recover from the toxicity of previous radiotherapy to grade 1 or less, without glucocorticoid treatment and without a history of radiation pneumonitis); (3) The end time of palliative radiotherapy is within 7 days before the first study drug administration; 6. Diagnosed with other malignant diseases other than NSCLC within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 7. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 8. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulation or synergistic inhibition of T cell receptors (eg, CTLA-4, OX-40, CD137); 9. Received systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use for pleural effusion control) within 2 weeks before the first administration; 10. Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 11. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) are allowed; 12. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not require drainage of effusion or who have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 13. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14. Those who are known to be allergic to the active ingredients or excipients of the study drugs such as sintilimab, pemetrexed, gemcitabine, carboplatin, and cisplatin; 15. Have not recovered sufficiently from toxicity and/or complications from any intervention (ie, <= grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment; 16. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive); 17. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor markers; | — |
Countries
China
Contacts
Public ContactZhou Xin
Qiqihar First Hospital
Outcome results
None listed