non-small cell lung cancer
Conditions
Interventions
Test group:Adebrelimab Combined with Linperlisib and Nab-paclitaxel
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All participants should sign an Informed Consent Form (ICF) before starting the study; 2. Prove advanced NSCLC through histopathological or cellular diagnosis; 3. Age = 18 years old, regardless of gender; 4. Objective imaging progression of patients after receiving advanced first-line treatment (RECIST v1.1 evaluation), which includes: PD- (L) 1 combination chemotherapy or first-line PD- (L) 1 monotherapy progression; 5. The optimal therapeutic effect of first-line immunotherapy is SD or above, and the PFS of first-line treatment is = 6 months; 6. Imaging evaluation (CT or MRI), with at least one measurable target lesion (RECIST v1.1); 7. ECOG PS 0-1 points; 8. Asymptomatic or treated stable brain metastasis patients can be included; 9. Expected survival time = 12 weeks; 10. Laboratory indicators that comply with the research protocol, including: (1) Blood routine: White blood cell count (WBC) = 3.0 × 109/L; Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelet count (PLT) = 80 × 109/L; Hemoglobin content (HGB) = 90 g/L (2) Liver function: In subjects without liver metastasis, aspartate aminotransferase (AST)1.5 × ULN and there is no clinical or imaging evidence of pancreatitis, it can be included in the study; Amylase = 1.5 x ULN. Alkaline phosphatase (ALP) = 2.5 x ULN, in subjects with bone metastases, ALP = 5 x ULN (6) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = 50%; 11. Female subjects with fertility must undergo a blood pregnancy test within one week before the first administration and the result is negative, and they are not breastfeeding. They must agree to use high-efficiency contraception measures during the study treatment period and 2 months after the last administration of adelbilimumab or 6 months after the last administration of linprixel/albumin paclitaxel (whichever is longer); For male participants whose partners are fertile women, they should agree to use high-efficiency contraception measures during the study treatment period and 2 months after the last administration of adelbizumab or 6 months after the last administration of linprixel/albumin paclitaxel (whichever is longer), and sperm donation is not allowed during the study period.
Exclusion criteria
Exclusion criteria: 1. Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration; 2. Received treatment with paclitaxel or albumin paclitaxel in the late stage; 3. Have received systemic treatment with traditional Chinese patent medicines and simple preparations or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) with anti lung cancer indications within 2 weeks before the first administration, or have received major surgical treatment within 3 weeks before the first administration; 4. Active brain metastasis or meningeal metastasis. But the following patients are allowed to be enrolled: those who have previously received brain or meningeal metastasis treatment (radiotherapy or surgery), if imaging before medication confirms stability for at least 4 weeks, and have stopped systemic hormone therapy (prednisone dose = 10mg/day or other equivalent hormones) for more than 4 weeks, and have no clinical symptoms; 5. Radiotherapy for the chest and whole brain should be completed less than 4 weeks before the first dose (palliative radiotherapy for bone lesions should be completed before the first dose and admission is allowed); 6. There is an uncontrollable third cavity effusion that requires drainage, such as a large amount of pleural effusion, ascites, or pericardial effusion; 7. Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes who received insulin therapy with a stabilizing dose, hypothyroidism patients who only needed hormone replacement therapy, and patients with skin diseases (such as eczema, vitiligo or psoriasis) that did not need systematic treatment and did not have acute exacerbation within one year before the screening period were excluded; 8. Individuals with congenital or acquired immune dysfunction, such as those infected with human immunodeficiency virus (HIV); 9. Suffering from the following poorly controlled infectious diseases: active hepatitis B (HBsAg positive and HBV DNA = 500IU/ml or 1000copies/ml) or hepatitis C (hepatitis C antibody positive and HCV RNA above the detection limit of the analytical method); Active tuberculosis or currently receiving anti tuberculosis treatment; 10. Objective evidence of past or present idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia in CT scans, or severe lung function impairment; 11. There are heart diseases that cannot be well controlled, including but not limited to (1) according to NYHA heart function classification, heart function level III-IV; (2) Acute coronary syndrome; (3) Supraventricular or ventricular arrhythmias that require clinical intervention (including QTc interval = 450ms for males and = 470ms for females); (4) Have experienced myocardial infarction within one year; (5) Echocardiography indicates a left ventricular ejection fraction (LVEF)38.5 ? within 2 weeks before the first administration (according to the researcher's judgment, fever caused by tumor can be included in the study); 13. Diagnosed with immunodeficiency or receiving systemic glucocortico
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Overall survival;Objective response rate;Safety; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed