None small cell lung cancer,NSCLC
Conditions
Interventions
Treatment group:Epalolithovolrelimab injection QL1706 5mg/kg, intravenous drip, once every 3 weeks (Q3W)
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histological subtype is squamous or non-squamous non-small cell lung cancer; 2. Age >= 65 years; 3. Patients who are not candidates for surgical resection or radical radiotherapy, or who refuse standard treatment; 4. At least one measurable lesion per RECIST 1.1 criteria; 5. ECOG performance status 0–2; 6. No known sensitizing EGFR, ALK, ROS1, RET, or BRAF V600E mutations; 7. PD-L1 positive (22C3 antibody, TPS >= 1%); 8. Life expectancy >= 12 weeks; 9. Adequate organ function, meeting the following criteria: (1) Neutrophil count (ANC) >= 1.5 × 10^9/L, (2) Platelets >= 100 × 10^9/L, (3) Hemoglobin >= 100 g/L, (4) Total bilirubin <= 1.5 × ULN, (5) ALT and AST < 3 × ULN, (6) Creatinine <= 1.5 × ULN; 10. Willingness to provide written informed consent and ability to understand and comply with study requirements.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the investigational drug or any of its excipients. 2. Major surgery (involving resection of at least one organ, including ovaries) within 28 days prior to the first dose. 3. History of other malignancies within the past 5 years, except for cured malignancies with no recurrence. 4. Untreated active brain metastases, or symptomatic brain metastases requiring urgent intervention. 5. Uncontrolled tumor-related pain. 6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently). 7. Uncontrolled or symptomatic hypercalcemia. 8. History of autoimmune diseases or immunodeficiency, such as systemic lupus erythematosus or rheumatoid arthritis. 9. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis; or evidence of active pneumonia on chest CT scan. 10. Prior treatment with immune checkpoint inhibitors, including but not limited to anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any therapy targeting immune co-stimulatory molecules involved in tumor immunity (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40). 11. Use of immunosuppressive agents or systemic corticosteroids for immunosuppression (prednisone or equivalent >=10 mg/day) within 2 weeks prior to dosing. 12. Use of herbal medicines with antitumor effects or immunomodulatory drugs (e.g., thymosin, interferon, interleukin-2) within 2 weeks prior to the trial. 13. Receipt of a live attenuated vaccine within 4 weeks before Day 1 of Cycle 1, or anticipated need for live attenuated vaccination during the study. 14. Patients with cognitive impairment-related disorders, such as Alzheimer's disease. 15. Any other condition deemed by the investigator as unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS;Overall survival,OS;Duration of Overall Response, DoR;Immune-related adverse event,irAE;Change in quality of life score (QLQ-ELD14 Questionnaire);Disease Control Rate, DCR; | — |
Countries
China
Contacts
Public ContactLiu Lihua
The Fourth Hospital of Hebei Medical University
Outcome results
None listed