Non-small Cell Lung Cancer (NSCLC) Stage IVBEACON-OLDNCT07849712
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
A study testing Benmelstobart Combined With Anlotinib in people with Non-small Cell Lung Cancer (NSCLC) Stage IV and Locally Advanced Non-Small Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 75 days and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC) Stage IV, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Benmelstobart Combined With Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yanjun Xu, M.D., +86 0571-88122222, xuyj@zjcc.org.cn
About this study
Official title: 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
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).
Read the detailed description
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).
- Conditions
- Non-small Cell Lung Cancer (NSCLC) Stage IV, Locally Advanced Non-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- Being tested
- Benmelstobart Combined With Anlotinib
- Keywords
- Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, PD-L1 Inhibitor, Anti-Angiogenesis, Benmelstobart
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benmelstobart Combined With AnlotinibDrug
Benmelstobart: Administered via intravenous infusion at a dose of 1200 mg every 3 weeks (Q3W). Anlotinib Hydrochloride: Administered orally at a dose of 10 mg daily, taken for 2 consecutive weeks followed by 1 week off, in repeated 3-week (21-day) cycles.
| Study group | Role | What they receive |
|---|---|---|
| Benmelstobart + Anlotinib | Experimental | Not described Receives: Drug: Benmelstobart Combined With Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: Up to 24 months
Incidence and Severity of Adverse Events (AEs)
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.
Measured: Up to 24 months.
Secondary outcomes (2)
Progression-Free Survival (PFS)
Length of time from the start of treatment until the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: Up to 24 months.
Overall Survival (OS)
Length of time from the start of treatment until death from any cause.
Measured: Up to 24 months (or survival follow-up up to 1 year after disease progression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer (NSCLC) Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanjun Xu, MD, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849712
- Sponsor's protocol ID
- IRB-2026-37（IIT）
- Acronym
- BEACON-OLD
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared because this is a single-center, exploratory investigator-initiated study (IIT) with a small sample size (N = 30), and the protocol does not include a pre-specified mechanism or consent framework for public IPD sharing in order to protect participant privacy and proprietary institutional data.
Publications
Maggiorani 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.
PubMed 38499573Wu 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.
PubMed 39418080Tsukita 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.
PubMed 38451530Voruganti 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.
PubMed 36701150Nosaki 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.
PubMed 31446994Lee 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.
PubMed 37423228Wu Y, Ju Q, Qian B, Zhang F, Shi H. The effectiveness of PD-1 inhibitors in non-small cell lung cancer (NSCLC) patients of different ages. Oncotarget. 2017 Dec 26;9(8):7942-7948. doi: 10.18632/oncotarget.23678. eCollection 2018 Jan 30.
PubMed 29487704Hou C, Wang Z, Lu X. Impact of immunosenescence and inflammaging on the effects of immune checkpoint inhibitors. Cancer Pathog Ther. 2023 Aug 9;2(1):24-30. doi: 10.1016/j.cpt.2023.08.001. eCollection 2024 Jan.
PubMed 38328711Xiong A, Wang J, Zhou C. Immunotherapy in the First-Line Treatment of NSCLC: Current Status and Future Directions in China. Front Oncol. 2021 Nov 25;11:757993. doi: 10.3389/fonc.2021.757993. eCollection 2021.
PubMed 34900707Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902