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
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Among 14 studies testing benmelstobart in Carcinoma, Non-Small-Cell Lung — 9 open to participants now, 9 under way, 2 of them phase 3. benmelstobart · Carcinoma, Non-Small-Cell Lung.
Among the 14 studies testing benmelstobart in Carcinoma, Non-Small-Cell Lung, this one is the 14th largest by planned enrollment, is the only one that started in 2026, is the only one with no phase, and was the 14th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →9 of the 14 studies testing benmelstobart in Carcinoma, Non-Small-Cell Lung are open now, in 1 country. Recruiting first, the newest first:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Sites in China
Ages 18–75
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
Ages 18–74
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Sites in China
Ages 18–80
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 75 Days and older · all sexes · no healthy volunteers.
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14 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 154 across the 14 interventional studies. None of them has completed or been terminated yet.
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8 of 14 have an industry lead sponsor. The 7 most frequent:
Zhejiang Cancer Hospital is the lead sponsor of 282 studies on the registry; 117 are open to participants now.
18 studies in Carcinoma, Non-Small-Cell Lung by Zhejiang Cancer Hospital: 3 open now, 4 under way, 1 of them phase 3. Of 3 finished, 0 (0%) have results posted.
Among the 18 studies in Carcinoma, Non-Small-Cell Lung by Zhejiang Cancer Hospital, this one is the 12th largest by planned enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2026, is the only one with no phase, and was the 18th registered.
Zhejiang Cancer Hospital’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2008.
1 of the studies testing benmelstobart in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06528847Shanghai Pulmonary Hospital, Shanghai, ChinaAdjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma | 2027-06-30 |
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Among the 14 studies testing benmelstobart in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among Zhejiang Cancer Hospital’s 18 in Carcinoma, Non-Small-Cell Lung:
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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 Form (ICF). Age $\ge 75$ years, male or female. (ECOG) performance status score of 0-2. Expected survival time $\ge 3$ months. or cytologically confirmed non-small cell lung cancer (NSCLC). Unresectable locally advanced (Stage IIIB/IIIC) or (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 v1.1 that can be accurately measured repeatedly. are permitted. Adequate organ function (without blood components or growth factors within 7 days prior to treatment):Hematology: (ANC) $\ge 1.5 \times 10\^9/\text{L}$; $\ge 100 \times 10\^9/\text{L}$; $\ge 90\text{ g/L}$. Renal: Calculated (CrCl) $\ge 50\text{ mL/min}$ (Cockcroft-Gault formula); Urine protein $\le 1+$ or 24-hour urine protein $\< 1.0\text{ g}$. Hepatic: Total (TBil) $\le 1.5 \times \text{}$; 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: (INR) and Activated Partial Thromboplastin Time (APTT) $\le 1.5 \times \text{ULN}$. Cardiac: (LVEF) $\ge 50\%$. Exclusion Criteria:Histopathological components of small cell lung cancer. Known driver gene-positive NSCLC eligible for standard targeted therapy. Active disease requiring systemic treatment within the past 2 years. History of immunodeficiency; positive antibody test; ongoing long-term systemic or 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, , 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; hemoptysis within 1 month prior to first dose.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Benmelstobart Combined With Anlotinib
Drug pages: Benmelstobart · 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.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
Of 344 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 26 months is below that.
Counting every sponsor, half of 360 studies reached it within 51 months; a quarter within 26 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Benmelstobart · Anlotinib
Carcinoma, Non-Small-Cell Lung →