Advanced non-small-cell lung cancer with negative driver genes
Conditions
Interventions
Experimental group:Combination of aprepitant Capsules combined with immunochemotherapy for advanced non-small cell lung cancer
Control group:Combination of Placebo capsules combined with immunochemotherapy for advanced non-small cell lung cancer
Sponsors
Huai'an First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Advanced and locally advanced non-small cell lung cancer NSCLC patients who have been histologically confirmed and have not undergone any treatment and are unable to undergo surgery; 2.All subjects were required to sign the informed consent form (ICF) before starting the study; 3.Age range: 18 to 75 years old; 4.Expected survival time >= 12 weeks; 5.According to the Solid Tumor Efficacy Evaluation Criteria 1.1 (RECIST v1.1), there is at least one measurable or evaluable lesion; 6.ECOG PS score is 0-2; 7.With adequate organ and bone marrow function; liver and renal function and Electrocardiogram meets the therapeutic requirements. 8.Patients are able to read, understand, and complete research survey questionnaires and logs, including Visual Analog Scale (VAS) questions; 9.In fertile women, the urine pregnancy test must be negative at the time of screening. If the urine pregnancy test results are positive, the patient will only be enrolled in the study if subsequent serum pregnancy tests are negative. 10.The patient meets one of the following conditions: (1)Fertile Women are need to consent to abstinence or to use dual barrier contraception 14 days before and during the study, and for at least one month after the last dose of study drug ; (2)Fertile Women taking oral contraceptives are need to consent to an additional barrier contraceptive 14 days before and during the study, and for at least one month after the last dose of the study drug; (3)The patient is infertile. Infertility is defined as one of the following: Natural menopause (natural menopause >=6 months and serum FSH test values in the postmenopausal range, or natural menopause >=12 months and age greater than 45 years); Or bilateral tubal ligation; Or 6 weeks after bilateral oophorectomy (with or without hysterectomy).
Exclusion criteria
Exclusion criteria: 1.History of primary immunodeficiency; 2.History of allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation; 3.Pregnant or lactating female patients; 4.Untreated acute or chronic active hepatitis B or C infected individuals; 5.Participated in other clinical trials in the past three months; 6.Lack of legal capacity or restricted legal capacity; 7.Allergies to aprepitant capsules, chemotherapy drugs, immune drugs, or other contraindications to medication; 8.Primary or metastatic central nervous system malignancies with clinical symptoms; 9.Abnormal laboratory results. (1) Blood routine: absolute neutrophil count (ANC)upper limit of normal x2.5 ,Total bilirubin (TBIL)>upper limit of normal x1.5; (3) Renal function: Creatinine (Cr) > upper limit of normal x1.5; 10.Active bleeding or newly diagnosed thrombotic disease is currently taking therapeutic doses of anticoagulant drugs or have a tendency to bleed; 11.Uncontrolled co-morbidities including but not limited to: HIV infection(HIV antibody positive),active infection or uncontrolled severe infection .Presence of serious or uncontrolled systemic disease (e.g. Severe mental diseases, neurological disorders, epilepsy or dementia, unstable or uncompensable respiratory, cardiovascular, liver or kidney diseases, uncontrolled severe hypertension. 12.The patient cannot swallow the capsule; 13.The Investigator believes that the subject may have other factors that could affect the study results and force the study to stop halfway,including the subject's unwillingness to comply with all procedures,other serious diseases (including mental disease)or severe laboratory abnormalities or that the treatment investigator considers such subjects unsuitable for participation in the study. 14.History of other primary malignancies.(Except for malignant tumors that have been cured, no tumor recurrence for >=5 years before clinical study and the risk of recurrence and metastasis are very low, Non-melanoma skin cancer or malignant lentigo without evidence of recurrence;Carcinoma in situ with adequate treatment and no evidence of disease recurrence);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival time,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year OS rate;2-year OS rate;Objective Efficiency Rate (ORR);Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public Contactaccelerate83
Huai'an First People's Hospital
Outcome results
None listed