Clinical trial · Interventional
An Exploratory Clinical Study Of Bempemab Combined With Anlotinib As First-Line Treatment For Elderly Patients With Locally Advanced Or Metastatic Non-Small-Cell Lung Cancer
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
NCT07849712CI-TRIAL-00126711BEACON-OLDnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer (NSCLC) Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Benmelstobart Combined With Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Benmelstobart + Anlotinib
- interventionNames
- Drug: Benmelstobart Combined With Anlotinib
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 24 months
- description
- Percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- measure
- Incidence and Severity of Adverse Events (AEs)
- timeFrame
- Up to 24 months.
- description
- Safety and tolerability profile evaluated by assessing the incidence, type, and severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and clinically significant abnormal laboratory test values, graded according to NCI CTCAE v5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Days
Show eligibility criteria text
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.References
Publications (10)
- BACKGROUNDMaggiorani D, Le O, Lisi V, Landais S, Moquin-Beaudry G, Lavallee VP, Decaluwe H, Beausejour C. Senescence drives immunotherapy resistance by inducing an immunosuppressive tumor microenvironment. Nat Commun. 2024 Mar 18;15(1):2435. doi: 10.1038/s41467-024-46769-9. PMID 38499573
- BACKGROUNDWu M, Yan J, Qiao C, Yan C. Impact of Concurrent Media Exposure on Professional Identity: Cross-Sectional Study of 1087 Medical Students During Long COVID. J Med Internet Res. 2024 Oct 17;26:e50057. doi: 10.2196/50057. PMID 39418080
- BACKGROUNDTsukita Y, Tozuka T, Kushiro K, Hosokawa S, Sumi T, Uematsu M, Honjo O, Yamaguchi O, Asao T, Sugisaka J, Saito G, Shiihara J, Morita R, Katakura S, Yasuda T, Hisakane K, Miyauchi E, Morita S, Kobayashi K, Asahina H. Immunotherapy or Chemoimmunotherapy in Older Adults With Advanced Non-Small Cell Lung Cancer. JAMA Oncol. 2024 Apr 1;10(4):439-447. doi: 10.1001/jamaoncol.2023.6277. PMID 38451530
- BACKGROUNDVoruganti T, Soulos PR, Mamtani R, Presley CJ, Gross CP. Association Between Age and Survival Trends in Advanced Non-Small Cell Lung Cancer After Adoption of Immunotherapy. JAMA Oncol. 2023 Mar 1;9(3):334-341. doi: 10.1001/jamaoncol.2022.6901. PMID 36701150
- BACKGROUNDNosaki K, Saka H, Hosomi Y, Baas P, de Castro G Jr, Reck M, Wu YL, Brahmer JR, Felip E, Sawada T, Noguchi K, Han SR, Piperdi B, Kush DA, Lopes G. Safety and efficacy of pembrolizumab monotherapy in elderly patients with PD-L1-positive advanced non-small-cell lung cancer: Pooled analysis from the KEYNOTE-010, KEYNOTE-024, and KEYNOTE-042 studies. Lung Cancer. 2019 Sep;135:188-195. doi: 10.1016/j.lungcan.2019.07.004. Epub 2019 Jul 8. PMID 31446994
- BACKGROUNDLee SM, Schulz C, Prabhash K, Kowalski D, Szczesna A, Han B, Rittmeyer A, Talbot T, Vicente D, Califano R, Cortinovis D, Le AT, Huang D, Liu G, Cappuzzo F, Reyes Contreras J, Reck M, Palmero R, Mak MP, Hu Y, Morris S, Hoglander E, Connors M, Biggane AM, Vollan HK, Peters S. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study. Lancet. 2023 Aug 5;402(10400):451-463. doi: 10.1016/S0140-6736(23)00774-2. Epub 2023 Jul 6.