Non-small cell lung cancer
Conditions
Interventions
Test group:PD-1/PD-L1 antibody + platinum-based doublet chemotherapy + low-dose radiotherapy
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.The patient must be confirmed with NSCLC through pathological or cytological diagnosis. 2.Clinical diagnosis is stage IV (AJCC 8th edition). 3.The type of driver-gene is negative(including patients with rare driver gene mutations but inaccessible to drugs). 4.Possessing one independent, measurable primary lung lesion based on RECIST 1.1 criteria, which is suitable for radiotherapy. 5.When accompanied by distant metastatic lesions, the following conditions should be met: 1)The patient should be conscious and mentally alert in cases of brain metastasis. 2)When lung metastases are present, there are only a few intrapulmonary metastatic lesions that do not impair lung function and are not within the radiation field of the primary lesion. 3)In the case of bone metastases, there are no irreversible events that severely impact the quality of life (such as pathological fractures, etc.). Furthermore, the recruitment of patients with more than 10 measurable metastatic lesions is discouraged. 6.Before initiating treatment, patients must sign an informed consent form that covers radiotherapy, chemotherapy, and immunotherapy, and they must not have any contraindications to these treatments. 7.Age >=18 years. 8.Have a performance status =4.0×10^9 /L, NEUT# >=2.0×10^9 /L, PLT >=100×10^9 /L, HGB >=100 g/L. 2)Hepatic indicators: within normal range. 3)Renal indicators: within normal range. 4)Lung function: FEV1 > 50%, or mild to moderate impairment of lung function. 10.The patient has good compliance with the treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients have been diagnosed with NSCLC, but the pathological type is neither adenocarcinoma nor squamous cell carcinoma. 2.Stage IV patients with malignant pleural or pericardial effusion. 3.Patients with liver metastasis or intrapulmonary metastasis, which have already affected liver function or lung function. 4.Patients with untreated brain metastasis, leptomeningeal metastasis, or spinal cord compression. 5.Patients with uncontrolled hypertension, diabetes, unstable angina pectoris, a history of myocardial infarction, or symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; electrocardiogram indicating ischemic changes or clinically diagnosed valvular heart disease; active phase of bacterial, fungal, or viral infections; psychiatric disorders; severely impaired lung function. 6.Pregnant or lactating patients. 7.Patients with a history of other active malignant tumors besides NSCLC before enrollment (Exceptions: malignancies treated with the intention to cure, with no known active disease for =5 years before enrollment and a low potential risk of recurrence; non-melanoma skin basal cell carcinoma, carcinoma in situ of the cervix, and cured early-stage prostate cancer). 8.Patients with active or previously documented autoimmune or inflammatory diseases, including: inflammatory bowel disease, diverticulitis, sarcoidosis syndrome, or other severe chronic gastrointestinal diseases associated with diarrhea; systemic lupus erythematosus; Wegener's granulomatosis [granulomatosis with polyangiitis]; Graves' disease; rheumatoid arthritis; uveitis; sarcoidosis syndrome, etc. (Exceptions: patients with vitiligo or cured childhood asthma/allergies; subjects requiring intermittent use of bronchodilators or local steroid injections; subjects with stable hypothyroidism or Sjögren's syndrome under hormone replacement therapy.) 9.Evidence of symptomatic interstitial lung disease or a history of (non-infectious) pneumonitis requiring steroids, or current pneumonia. 10.Patients with allergic constitution and known or suspected allergy to any drugs used in the study without alternative medications. 11.Previous history of tuberculosis. 12.History of active primary immunodeficiency. 13.Known active hepatitis B (e.g., HBsAg positive) or hepatitis C (e.g., detectable HCV RNA). 14.Patients with a history of allogeneic organ transplantation. 15.Patients who are currently receiving any other investigational drugs. 16.Patients with poor compliance. 17.Patients whom the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation;Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DoR;Progerssion Free Survival, PFS;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactWang Yanyang
General Hospital of Ningxia Medical University
Outcome results
None listed