non-small cell lung cancer
Conditions
Interventions
Cohort1:The antihypertensive medication includes ARB class drugs
Cohort2:The antihypertensive medication does not include ARB class drugs.
Cohort3:Exceptional case
Sponsors
Wuxi people’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The participant voluntarily joins the study and signs an informed consent form. 2.A history of diagnosed hypertension that meets the medication intervention criteria of the 2024 edition of the "Chinese Guidelines for Hypertension Prevention and Treatment; 3.Diagnosis of non-small cell lung cancer (NSCLC) confirmed by histopathological or cytological examination; 4.Aged between 18 and 75 years, regardless of gender; 5.Clinical stage confirmed as stage IV or unresectable locally advanced (stage IIIb-IIIc) according to the AJCC 8th edition staging system; 6.No prior systemic antitumor treatment for advanced NSCLC. Participants with recurrent NSCLC who have received adjuvant or neoadjuvant treatment (chemotherapy, radiotherapy, or other treatments) are eligible if the time from the last treatment to recurrence exceeds 6 months; 7.At least one measurable lesion according to RECIST v1.1 criteria; 8.Expected survival of at least 12 weeks; 9.Agreement to provide tumor tissue samples either archived or freshly obtained, with one slide of 4–6 µm thickness at the time of diagnosis of advanced NSCLC or thereafter; 10.An ECOG performance status score of 0 or 1; 11.Function of important organs meets the following criteria (excluding the use of any blood components and cell growth factors during the screening period): Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelet count (PLT) >= 100 × 10^9/L; Hemoglobin (HB) >= 9 g/dL; Serum albumin >= 3 g/dL; Thyroid-stimulating hormone (TSH) = 60 mL/min. 12.Female participants of childbearing potential and male participants with partners of childbearing potential must use an effective contraceptive method during the study treatment period and for at least 6 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1.Prior treatment with any anti-PD-1/PD-L1 or other forms of immunotherapy; 2.Known active central nervous system metastasis that has not been treated surgically or radiologically; 3.History of other malignancies within the last 5 years, excluding cured basal cell carcinoma of the skin and all forms of in situ cancer; 4.Any antitumor treatment within 4 weeks prior to enrollment; 5.Poor compliance with treatment, unable to adhere to prescribed medication; 6.Pregnant or breastfeeding women (women of childbearing age must have a negative pregnancy test within 14 days prior to the first administration; if positive, pregnancy must be excluded by ultrasound); 7.Significant gastrointestinal dysfunction or disease that could affect drug absorption (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); 8.Baseline presence of symptomatic ascites, pleural effusion, or pericardial effusion requiring drainage, or having undergone effusion drainage within 4 weeks prior to the first administration; 9.History of immunodeficiency disorders, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 10.Major surgical procedures or significant trauma within 4 weeks prior to treatment initiation, or anticipated major surgical procedures; 11.Serious comorbidities that may endanger patient safety or affect the completion of the study (e.g., rapidly progressive hypertension or hypertensive encephalopathy, diabetes, thyroid disease, active hepatitis B, and other active infections); 12.Inability to understand or comply with study instructions and requirements; 13.The investigator has determined as unfit to attend this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Reactive telangiosis; | — |
Countries
China
Contacts
Public ContactJunying Xu
Wuxi people’s Hospital
Outcome results
None listed