Lung cancer
Conditions
Interventions
Test group:Lactulose + Fluorocytosine
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent form (ICF); 2. At the time of signing the ICF, be aged between 18 and 75 years old (inclusive), male or female; 3. Expected survival time >= 3 months; 4. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer's 8th edition of the Lung Cancer TNM Staging, have histological or cytological evidence of locally advanced (III B/III C stage), metastatic or recurrent (IV stage) NSCLC that cannot be surgically resected and cannot undergo radical concurrent radiotherapy and chemotherapy; 5. Have a written test report from a regular institution proving the presence of KRAS G12C mutation; 6. ECOG performance status score (PS) of 0-1; 7. Have not received any systemic anti-tumor treatment for locally advanced or metastatic non-squamous NSCLC previously; Subjects who have received adjuvant treatment are allowed, but the disease recurrence must be at least 6 months after the last administration of adjuvant therapy or the last radical radiotherapy; 8. Have at least one measurable lesion (in accordance with the RECIST 1.1 standard); located within the irradiated field of previous radiotherapy or a measurable lesion after local treatment, if progression is confirmed, it can be selected as a target lesion; 9. Have adequate organ and bone marrow functions, including: Have sufficient hematopoietic function, i.e., absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 9g/dL. Blood routine tests should not have received blood transfusion or granulocyte colony-stimulating factor, thrombopoietin, erythropoietin, etc. within 14 days before the test. Have sufficient liver function, i.e., total bilirubin (TBIL) 1.5×ULN, the calculated creatinine clearance rate (CrCl) using the Cockcroft-Gault formula >= 60 mL/min. Have sufficient coagulation function, i.e., prothrombin time (PT)/activated partial thromboplastin time (APTT) < 1.5×ULN, and international normalized ratio (INR) < 1.5 or within the target range of anticoagulation treatment. Blood magnesium is within the normal range. 10. The toxic reactions from previous anti-tumor treatment need to recover to the baseline level (except for residual hair loss effects) or = grade 1 before enrollment (neurotoxicity can be <= grade 2). Previous immune therapy-induced endocrine-related irAE, such as immune-related hypothyroidism, after treatment is controlled and stable without symptoms, still requires stable doses of hormone replacement or physiological doses of corticosteroids, and can be enrolled after assessment by the investigator does not affect the administration of the study drug and safety assessment. 11. Pregnant female participants or male participants whose partner is a pregnant female, take effective contraceptive measures from the time of signing the informed consent form until 6 months after the last administration of the study drug. Blood pregnancy test results of fertile female participants should be negative (including the 7-day period befor
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria shall not be enrolled in this study: 1. Histologically or cytologically confirmed NSCLC with small-cell components, or mixed-type NSCLC predominantly composed of squamous cell carcinoma components; 2. Subjects harboring EGFR sensitizing mutations, ALK rearrangements, ROS1 fusion mutations, or other gene mutation types for which first-line treatment of NSCLC has been approved by the NMPA; 3. Significant cardiovascular or cerebrovascular diseases, such as: * Clearly documented cardiovascular events within 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or having undergone angioplasty, vascular stent implantation, coronary artery bypass grafting, etc. * Clinically significant prolongation of the QT/QTcF interval on electrocardiogram: QTcF >470 ms in females or >450 ms in males; * Clearly documented cerebrovascular events within 3 months, such as cerebral hemorrhage or cerebral infarction; 4. Active central nervous system metastases, such as brain metastases or leptomeningeal metastases. Subjects with brain metastases who have received radiotherapy or local treatment may be enrolled if they have been asymptomatic for at least 7 days after completion of radiotherapy without the use of corticosteroids or antiepileptic drugs; or, if corticosteroids or antiepileptic drugs were used, they must have been discontinued and the subject must have been asymptomatic for at least 7 days, with stable control of brain metastases as judged by the investigator; 5. Currently clinically significant interstitial lung disease, radiation pneumonitis, or drug-related pneumonitis requiring treatment; active pulmonary tuberculosis; pneumoconiosis; other types of pneumonia of Grade =2; or severe pulmonary function impairment confirmed by pulmonary function testing, defined as FEV1, DLCO, or DLCO/VA =160 mmHg or diastolic blood pressure =100 mmHg, diabetes mellitus, etc. 10. Other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, prostate cancer requiring no treatment, ductal carcinoma in situ of the breast, and superficial non-muscle-invasive urothelial carcinoma; 11. Prior treatment with a KRAS G12C inhibitor; 12. Prior treatment with etoposide or other DNA topoisomerase II inhibitors; 13.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective relief rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Disease control rate, DCR;Time to response, TTR;Progression-Free Survival, PFS; | — |
Countries
China
Contacts
Public ContactChunxia Su
Shanghai Pulmonary Hospital
Outcome results
None listed