Bemo-sufail Monoclonal Antibody Combined With Anlotinib As First-Line Treatment For Elderly Patients With Locally Advanced Or Metastatic Non-Small-Cell Lung Cancer: An Exploratory Clinical Study
| Registry | NCT07849712, acronym BEACON-OLD |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Zhejiang Cancer Hospital (Other) |
| Conditions | Non-small Cell Lung Cancer (NSCLC) Stage IV, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer |
| Interventions | Benmelstobart Combined With Anlotinib (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-09-30, last updated 2026-09-30 |
| Locations | 1 site in China |
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All trials for Non-small Cell Lung Cancer (NSCLC) Stage IV All trials for Locally Advanced Non-Small Cell Lung Cancer All trials of Benmelstobart Combined With Anlotinib
This exploratory clinical study evaluates the efficacy and safety of combining benmelstobart (a PD-L1 inhibitor) with anlotinib (a multi-target anti-angiogenic TKI) as a first-line, chemotherapy-free treatment for elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
Target Population: Patients aged 75 years or older with stage IIIB/IIIC (unresectable) or stage IV NSCLC who have no EGFR/ALK driver mutations and cannot tolerate or refuse standard chemotherapy/radiotherapy. Treatment Plan: Participants receive a combination of intravenous benmelstobart (1200 mg every 3 weeks) and oral anlotinib (10 mg daily for 2 weeks, followed by 1 week off) in 21-day cycles. Study Duration: Treatment continues for up to 24 months (35 cycles), or until disease progression or unacceptable toxicity occurs. Primary Objective: Assess the treatment's efficacy by measuring the Objective Response Rate (ORR). Secondary Objectives: Evaluate overall safety, Progression-Free Survival (PFS), and Overall Survival (OS).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Benmelstobart + Anlotinib | Experimental | Drug: Benmelstobart Combined With Anlotinib |
Sex: All, ages: 75 Days to any
Inclusion Criteria:Voluntary signed written Informed Consent Form (ICF). Age $\\ge 75$ years, male or female. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival time $\\ge 3$ months. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC that cannot receive radical concurrent/sequential chemoradiotherapy (according to the AJCC/UICC 8th TNM staging). No EGFR sensitive mutations or ALK gene translocations. (Non-squamous NSCLC patients must provide prior tissue test reports; squamous NSCLC patients with unknown status do not require testing and are regarded as negative). Intolerant to or refusing chemotherapy/radiotherapy. At least one measurable target lesion per RECIST v1.1 that can be accurately measured repeatedly. Brain metastases are permitted. Adequate organ function (without blood components or growth factors within 7 days prior to treatment):Hematology: Absolute Neutrophil Count (ANC) $\\ge 1.5 \\times 10\^9/\\text{L}$; Platelets $\\ge 100 \\times 10\^9/\\text{L}$; Hemoglobin $\\ge 90\\text{ g/L}$. Renal: Calculated Creatinine Clearance (CrCl) $\\ge 50\\text{ mL/min}$ (Cockcroft-Gault formula); Urine protein $\\le 1+$ or 24-hour urine protein $< 1.0\\text{ g}$. Hepatic: Total Bilirubin (TBil) $\\le 1.5 \\times \\text{ULN}$; AST and ALT $\\le 2.5 \\times \\text{ULN}$ ($\\le 5 \\times \\text{ULN}$ for patients with liver metastases); Serum Albumin $\\ge 28\\text{ g/L}$. Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) $\\le 1.5 \\times \\text{ULN}$. Cardiac: Left Ventricular Ejection Fraction (LVEF) $\\ge 50\\%$. Exclusion Criteria:Histopathological components of small cell lung cancer. Known driver gene-positive NSCLC eligible for standard targeted therapy. Active autoimmune disease requiring systemic treatment within the past 2 years. History of immunodeficiency; positive HIV antibody test; ongoing long-term systemic corticosteroids or immunosuppressive agents. Active tuberculosis or active syphilis infection. History of allogeneic organ or stem cell transplantation. History or current presence of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoids. Severe infection within 4 weeks prior to first dose; active infection requiring systemic anti-infective therapy within 2 weeks prior to first dose. Presence of brainstem, meningeal, or spinal cord metastases or compression. History of myocarditis, cardiomyopathy, or malignant arrhythmia; unstable angina, myocardial infarction, congestive heart failure, or vascular disease requiring hospitalization within 12 months prior to first dose. History of esophageal/gastric varices, severe ulcer, unhealed wound, gastrointestinal perforation/fistula/obstruction, or acute GI bleeding within 6 months prior to first dose. Arterial thromboembolism, Grade $\\ge 3$ venous thromboembolism, TIA, CVA, hypertensive crisis, or uncontrolled hypertension ($\\text{SBP} \\ge 160\\text{ mmHg}$ or $\\text{DBP} \\ge 100\\text{ mmHg}$) within 6 months prior to first dose. Severe bleeding tendency or coagulation disorder; clinically significant hemoptysis within 1 month prior to first dose.| Facility | City | Country | Status |
|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou, Zhejiang | China |