Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Trial group:Docetaxel 60-75 mg/m^2 intravenous infusion, Day 1, every 3 weeks
combined with glutamine 4 g per dose, oral after meals, three times daily
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18, male or female; 2. Patients are expected to have a life expectancy of at least 12 weeks at the time of screening; 3. Patient types and disease characteristics: (1) Patients with clinically confirmed KRAS G12D mutant non-small cell lung cancer who have failed after at least first-line therapy; (2) The World Health Organization (WHO) /ECOG physical status (PS) is 0 or 1; (3) At least one target lesion meeting RECIST 1.1 criteria at baseline; (4) There is no restriction on the previous systematic treatment regimens before enrollment, including chemotherapy, immunotherapy, targeted therapy, etc.; (5) With full organ and bone marrow function, defined as follows: 1) Hemoglobin >= 8.0 g/dL; 2) Absolute neutrophil count >=1.5×10^9/L; 3) Platelet count >=90×10^9/L; 4) Serum bilirubin <=2.0× upper limit of normal (ULN); For patients with liver metastasis, serum bilirubin <=5.0× upper limit of normal; These conditions do not apply to patients with proven Gilbert syndrome. Any clinically significant biliary obstruction should be relieved before randomization; 5) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×ULN; For patients with liver metastases, ALT and AST <=5 × ULN.
Exclusion criteria
Exclusion criteria: 1. Other malignancies known to be progressing or requiring active treatment. Excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has received radical treatment; 2. Medical history or evidence of disease that may confound the results of the trial, prevent the subject from fully participating in the study, abnormal treatment or laboratory values, or the investigator believes that participation in the study is not in the subject's best interest; 3. Female subjects who are pregnant or lactating, or expect to become pregnant during the planned trial or until 180 days after the last dose of study treatment, or male subjects who impregnate their spouse; 4. Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody); 5. Patients who in the investigator's judgment are unlikely to comply with the study procedures, restrictions, and requirements shall not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Incidence of adverse events (Such as adverse events, Serious adverse events, Fatal adverse events);Laboratory tests (e.g., liver and kidney function); | — |
Countries
China
Contacts
Public ContactZhong Xian
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed