non-small cell lung cancer
Conditions
Interventions
Butyrate Treatment Group:oral administration of 1200mg butyrate
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC. 3. Radiographic disease progression (according to RECIST 1.1 criteria) after achieving disease stability for at least 6 months (180 days) on first-line treatment containing Pembrolizumab. 4. At least one measurable lesion (according to RECIST 1.1 criteria). 5. ECOG performance status of 0-1, and a life expectancy of >= 3 months. 6. Adequate organ function defined as: absolute neutrophil count (ANC) >= 1.5 x 10?/L, platelet count >= 75 x 10?/L, hemoglobin >= 90 g/L, total bilirubin = 50 mL/min. 7. Negative serum pregnancy test for women of childbearing potential; agreement to use effective contraception during the study period and for 180 days after the last dose. 8. Voluntary provision of signed informed consent, and ability to comply with the study protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Having received any of the following treatments: Major surgery within 4 weeks prior to the first dose of the study drug; Radiation therapy to over 30% of the bone marrow or large-field radiotherapy within 4 weeks prior to the first dose of the study drug. 2. Toxicities from previous anticancer therapy have not resolved to = Grade 1 (except for alopecia). 3. Symptomatic brain metastases or spinal cord compression (except for those who are asymptomatic, stable, and have not required steroid treatment for at least 4 weeks prior to initiation of study treatment). 4. Presence of severe or uncontrolled systemic diseases, organ dysfunction, or active infection, including but not limited to: uncontrolled hypertension or diabetes; active autoimmune disease; active infection (e.g., HBV, HCV, HIV); severe cardiovascular or cerebrovascular diseases (e.g., unstable angina, heart failure, myocardial infarction); clinically significant gastrointestinal dysfunction that may affect drug absorption (e.g., inability to take oral medication, refractory nausea/vomiting, extensive gastrointestinal resection, uncontrolled inflammatory bowel disease); cardiac abnormalities (e.g., clinically significant arrhythmias, left ventricular ejection fraction (LVEF) <50% on echocardiogram); interstitial lung disease, drug-induced interstitial lung disease, or a history of radiation pneumonitis requiring steroids; severely impaired lung function (FEV1/FVC <70% and FEV1% <30%; DLCO% <40%). 5. History of Grade 3 or higher immune-related adverse events (with the exception of endocrinopathies). 6. Any other condition deemed by the investigator as inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Duration of relief;Progression free survival;time to progress;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Mengzhao
Peking Union Medical College Hospital
Outcome results
None listed