An interventional study of Benmelstobart Combined With Anlotinib in Non-small Cell Lung Cancer (NSCLC) Stage IV, Locally Advanced Non-Small Cell Lung Cancer and Metastatic Non-small Cell Lung Cancer, sponsored by Zhejiang Cancer Hospital. Not yet recruiting at 1 site in China. Open to participants aged 75 Days and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment
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).
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.
Drug: Benmelstobart Combined With Anlotinib
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.
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.
Time frame: 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.
Time frame: Up to 24 months.
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.
Time frame: Up to 24 months.
Overall Survival (OS)
Length of time from the start of treatment until death from any cause.
Time frame: Up to 24 months (or survival follow-up up to 1 year after disease progression)
Plan to share: 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.
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Carcinoma, Non-Small-Cell Lung→
Zhejiang Cancer Hospital