Advanced non-small cell lung cancer
Conditions
Interventions
Experimental group:Epalolitovorellizumab in combination with Docetaxel
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, male or female; 2.Histologically or cytologically documented unresectable or metastatic NSCLC, staged per AJCC 8th-edition TNM system; 3.Wild-type for EGFR, ALK, and ROS1 (for other driver genes, patients are eligible if no approved targeted therapy is available for first-line treatment or if patients refuse targeted therapy); 4.No prior treatment with docetaxel; 5.Disease progression during first-line advanced treatment containing immune checkpoint inhibitors (PD-1/L1) or progression within 6 months after discontinuation of such treatment; 6.No prior treatment with CTLA-4 inhibitors; 7.Presence of measurable lesions (per RECIST 1.1 criteria: tumor lesions with a longest diameter = 10 mm on CT scan; lymph node lesions with a shortest diameter >=15 mm on CT scan); 8.Expected life expectancy of more than 3 months; 9.ECOG performance status score of 0–2; 10.Normal function of major organs, meeting the following criteria:? (1) Routine blood test results (without blood transfusion, hematopoietic factor use, or medication correction within 14 days) must meet:? a. Absolute Neutrophil Count (ANC) >=1.8×10^9/L;? b. Hemoglobin (HB) >= 100 g/L;? c. Platelet (PLT) >= 125×10^9/L;? (2) Biochemical test results must meet:? a. Total Bilirubin (TBIL) = 50 ml/min (calculated by Cockcroft-Gault formula); 11.Female subjects of childbearing potential must undergo a urine pregnancy test within 3 days before the start of study drug administration, with a negative result. They must also agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and within 180 days after the last dose of study drug. Male subjects whose partners are of childbearing potential must agree to use effective contraceptive methods during the study period and within 180 days after the last dose of study drug; 12.Subjects voluntarily participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up;
Exclusion criteria
Exclusion criteria: 1.Patients with known sensitive EGFR mutations (19Exon del/21Exon L858R), positive ALK/ROS1 fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation, or positive RET gene fusion; 2.Use of immunosuppressive drugs within 4 weeks before the first administration of the study drug, excluding intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., no more than 10 mg/day of prednisolone or equivalent physiological doses of other corticosteroids, and discontinuation for >=1 week); 3.Active brain metastasis or meningeal metastasis. However, the following patients are eligible for enrollment: those who have previously received treatment for brain or meningeal metastasis (radiotherapy or surgery), with imaging confirmation of stability for at least 2 weeks before enrollment, discontinuation of systemic hormone therapy for more than 2 weeks (prednisone dose =10 mg/day or other equivalent hormone replacement therapy is allowed), and no clinical symptoms; radiotherapy for the chest and whole brain must be completed >4 weeks before enrollment (palliative radiotherapy for bone lesions completed before the first administration is allowed for enrollment); 4.Systemic treatment with Chinese herbal medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) within 3 weeks before the first administration; 5.History of malignant tumors other than NSCLC within 5 years before enrollment; 6.Receipt of live-attenuated vaccines within 4 weeks before the first administration or planned receipt during the study period; 7.Currently participating in interventional clinical study treatment, or receiving other study drugs or study device treatment within 4 weeks before the first administration; failure to fully recover from toxicity and/or complications caused by any intervention before the first administration (i.e., 38.5°C during screening/before the first administration; 9.History of pneumonia/interstitial lung disease (ILD) (confirmed or suspected) or any lung disease that may affect pulmonary function tests; 10.History of any active autoimmune disease or past autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after hormone replacement therapy)); patients with childhood asthma that has been completely relieved and requires no intervention in adulthood or vitiligo are eligible; patients requiring medical intervention with bronchodilators are not eligible; 11.Patients with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, combined hepatitis B and C co-infection, or alcoholic cirrhosis; 12.Myocardial ischemia or myocardial infarction of Grade II or above, poorly controlled arrhythmia (including QTc interval >=450 ms in males and >=470 ms in females); New York Heart Association (NYHA) Class III–IV heart failure, or left ventricular ejection fraction (LVEF) <50% confirmed by echocardiography; myocardial infarction within 6 months before enrollment, NYHA Class II or above heart failure, uncon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Duration of Response;Overall survival ;Safety; | — |
Countries
China
Contacts
Public ContactLiangliang Dong
Yantai Yuhuangding Hospital
Outcome results
None listed