NSCLC
Conditions
Interventions
Test group:anti-PD-1 inhibitors combined with metronomic oral vinorelbine as the first-line treatment
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Inclusion age is 70 years and above ? ECOG 0-1 points ? NSCLC patients who have been confirmed by histology or cytology to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy for locally advanced or metastatic (stage IIIB, IIIC, or IV) NSCLC ? No EGFR mutation, ALK fusion positive, or ROS1 fusion positive confirmed by tumor histology or cytology ? Patients who have not received any systematic anti-tumor treatment for locally advanced/metastatic diseases in the past (for patients who have received platinum containing adjuvant chemotherapy, neoadjuvant chemotherapy, or radical radiotherapy and chemotherapy for advanced diseases, if the disease progression occurs more than 6 months after the end of the last treatment, they are eligible to participate in this study) ? The expected life is at least 3 months ? Researchers have confirmed the presence of at least one measurable lesion according to the RECIST 1.1 standard. ? The main organ function is normal, and the test results during screening must meet the following requirements: 1) The blood routine examination standards must meet (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): a Hemoglobin (Hb) = 90 g/L b. Neutrophil count (ANC) = 1.5 × 109/L c. Platelet count (PLT) = 100 × 109/L. 2) Biochemical examination should meet the following standards: a Alanine transaminase and AST60ml/min (Cockcroft Fault formula) c. The urine routine test results show that urine protein (UPRO)<++or 24-hour urine protein quantification<1g. ?Subjects are required to use effective contraceptive methods, medically acceptable contraceptive methods are: a surgical sterilization (e.g. tubal ligation, hysterectomy, vasectomy), b. Hormonal contraceptives approved by the State Drug Administration (such as contraceptive pills, patches, implants or injectable preparations), c. Barrier method to kill sperm (such as condoms or diaphragms), d. IUD. Emergency contraception taken after unprotected sex, such as the morning-after pill, cannot be used as a regular method of contraception. If a subject becomes pregnant during the study or has unprotected sex with a partner, the study physician and partner should be informed immediately.
Exclusion criteria
Exclusion criteria: ? Active brain metastasis patients (brain metastasis patients whose lesions remain stable for at least 2 weeks after treatment) ? Patients who has received the following therapies in the past: anti PD-1, anti PD-L1 or anti PD-L2 drugs or another drug that stimulates or cooperatively inhibits T-cell receptor (for example, CTLA-4, OX-40, CD137) ? Immunosuppressive drugs were used within 14 days before the first use of PD-1 inhibitor, excluding nasal and inhalation corticosteroid or systemic sex hormone with physiological dose (i.e. no more than 10 mg/day prednisolone or other corticosteroid with physiological dose of equivalent drugs) ? Active autoimmune disease or immune deficiency, or the above medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, etc.) shall not be included. ? Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drug) occurred within 4 weeks before the first administration, or fever of unknown cause>38.5 ° C occurred during screening/before the first administration ? Within 30 days of initial medication or expected to receive live attenuated vaccines during the study period ? Untreated active hepatitis B, hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the detection limit of the analytical method) or co infection of hepatitis B and hepatitis C ?Note: hepatitis B patients who meet the following criteria also meet the inclusion criteria: before the first administration, the HBV Viral load must be<1000 copies/ml (200 IU/ml), and the patients should receive anti HBV treatment during the whole study chemotherapy drug treatment to avoid virus reactivation. For subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV Viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored ?Patients with a clear history of allergies are known to have allergic reactions to the active ingredients a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;1 year OS%;Objective response rate;Disease control rate;Duration of overall response; | — |
Countries
China
Contacts
Public ContactLi Lin
Beijing Hospital
Outcome results
None listed