Large-Cell Neuroendocrine Carcinoma of the LungPhase 2NCT07510594
A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC
A Phase 2 study testing Benmelstobart+ Anlotinib+ Platinum + Etoposide in people with Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Large-Cell Neuroendocrine Carcinoma of the Lung, Extrapulmonary Neuroendocrine Carcinoma
- What is being tested?
- Benmelstobart+ Anlotinib+ Platinum + Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic LCNEC or EP-NEC (per AJCC 9th Edition);
- No prior systemic treatment for locally advanced or metastatic LCNEC or EP-NEC; For patients who have received adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy for non-metastatic disease with curative intent, or definitive chemoradiotherapy for locally advanced disease, the interval from the end of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of metastatic NEC must be at least 6 months (calculated from the end date of the last chemotherapy cycle or the end date of the last radiotherapy);
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Lesions that have received prior radiotherapy can be considered measurable only if there is clear progression after radiotherapy and they are not the only lesion;
- Aged 18-75 years;
- ECOG Performance Status 0-1;
- Life expectancy ≥3 months;
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- Sufficient hematological and organ function, meeting the following criteria:
- Hematology (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulants): Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; Platelet Count (PLT) ≥100×10⁹/L; White Blood Cell (WBC) Count ≥3×10⁹/L;
- Biochemical tests:
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×Upper Limit of Normal (ULN), or ≤5×ULN in patients with liver metastasis; Total Bilirubin (TBIL) ≤1.5×ULN, or ≤3×ULN in patients with Gilbert's syndrome; Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance (CCr) ≥50mL/min;
- Coagulation function:
- Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), or Prothrombin Time (PT) ≤1.5×ULN;
- Doppler ultrasound assessment:
- Left Ventricular Ejection Fraction (LVEF) ≥50%;
- Women and men of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and within 6 months after the last dose of study medication; Women must have a negative serum pregnancy test within 7 days before study randomization and must not be breastfeeding;
- Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Patients with brain metastasis and/or carcinomatous meningitis (excluding asymptomatic patients or patients with stable condition who have no imaging evidence of new/enlarged central nervous system metastasis for at least 2 weeks after brain metastasis treatment and have discontinued steroids or anticonvulsants for at least 14 days before the study; If active or new untreated asymptomatic central nervous system metastasis is detected during the screening phase, subjects must receive radiotherapy, or have no imaging evidence of new/enlarged brain metastasis for at least 2 weeks without treatment);
- Prior use of anti-angiogenic drugs such as Anlotinib, Apatinib, Bevacizumab, or immunotherapeutic drugs targeting PD-1, PD-L1, etc.;
- History of other malignant tumors within 5 years (except cured carcinoma in situ of the cervix or basal cell carcinoma of the skin);
- Factors affecting oral drug administration (dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Spinal cord compression not cured or relieved by surgery and/or radiotherapy, or no clinical evidence of stable condition for ≥1 week after treatment of previously diagnosed spinal cord compression before randomization;
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- Imaging (Computed Tomography [CT]/Magnetic Resonance Imaging [MRI]) showing tumor invasion of large blood vessels or unclear boundary with large blood vessels;
- Patients with imaging evidence of tumor invasion around major blood vessels, or judged by the investigator to have a high risk of tumor invading major blood vessels leading to fatal massive hemorrhage during the subsequent study period;
- History of severe bleeding tendency or coagulation dysfunction, including but not limited to: clinically significant hemoptysis (hemoptysis >1 tablespoon per day) within 3 months before enrollment; or bleeding symptoms or bleeding tendency of significant clinical significance within 4 weeks before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer (including gastrointestinal perforation and/or fistula, except for patients with gastrointestinal perforation or fistula who have undergone surgical resection and are eligible for enrollment), unhealed wounds, ulcers, or fractures;
- Unresolved treatment-related toxicity (>Grade 1) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (except alopecia);
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before randomization;
- Arterial/venous thromboembolic events (such as cerebrovascular accident [including transient ischemic attack], deep vein thrombosis, and pulmonary embolism) within 6 months before randomization;
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose;
- Vaccination with prophylactic or attenuated vaccines within 28 days before the first dose;
- Severe allergic reaction to other monoclonal antibodies;
- History of psychotropic drug abuse that cannot be abstained from, or mental disorders;
- Any severe and/or uncontrolled disease:
- Poorly controlled blood pressure (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg);
- Grade II or above myocardial ischemia or myocardial infarction, arrhythmia (including corrected QT interval [QTc] ≥450ms in men and QTc ≥470ms in women); congestive heart failure with New York Heart Association (NYHA) Functional Class II-IV;
- Active or uncontrolled severe infection (≥Grade 2);
- Liver cirrhosis, active hepatitis (hepatitis B: positive hepatitis B surface antigen and hepatitis B virus deoxyribonucleic acid >ULN; hepatitis C: positive hepatitis C antibody and hepatitis C virus titer >ULN);
- Human Immunodeficiency Virus (HIV) positive;
- Poorly controlled diabetes (fasting blood glucose >10mmol/L);
- Urinary protein ≥++, and confirmed 24-hour urinary protein >1.0g;
- Participation in other clinical trials within 28 days before the study;
- Other conditions that increase the risk related to study participation or study drugs and are deemed by the investigator to make the patient unsuitable for enrollment.
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
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Single-Center, Single-Arm, Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as First-Line Treatment for Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma
To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC)
Read the detailed description
This study is a single-center, single-arm, phase II study designed to observe and evaluate Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma (LCNEC) of the lung and extrapulmonary neuroendocrine carcinoma (EP-NEC).
Enrolled patients are those with histologically or pathologically confirmed metastatic LCNEC or EP-NEC (AJCC 9th edition) who have not received systemic treatment. Eligible subjects will receive 4 cycles of Benmelstobart combined with Anlotinib and chemotherapy, followed by maintenance treatment with Benmelstobart combined with Anlotinib, with continuous medication until disease progression or intolerable toxicity. The purpose of this study is to evaluate the efficacy and safety of Benmelstobart Injection combined with Anlotinib Hydrochloride and chemotherapy as first-line treatment for advanced LCNEC and EP-NEC.
- Being tested
- Benmelstobart+ Anlotinib+ Platinum + Etoposide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benmelstobart+ Anlotinib+ Platinum + EtoposideDrug
Treatment phase (intensive combination treatment) : 4 cycles, with each treatment cycle lasting 21 days: 1) Benmelstobart: 1200mg per dose, administered intravenously (IV) once every 21 days; 2) Anlotinib: 12mg per dose, taken orally (po) for 2 consecutive weeks followed by 1 week of rest; 3) Carboplatin: administered on Day 1, with an AUC of 5mg/mL/min via IV infusion (maximum dose: 750mg); \& Cisplatin: administered on Day 1, 75-80mg/m² via IV infusion; 4) Etoposide: administered continuously on Days 1, 2, and 3, 100mg/m² via IV infusion; Maintenance phase: 1) Maintenance treatment will be continued until loss of clinical benefit, intolerable toxicity, efficacy evaluation of PD, or judgment by the investigator that continued medication is inappropriate; 2) Benmelstobart: 1200mg per dose, administered IV once every 21 days; 3) Anlotinib: 12mg per dose, taken orally for 2 consecutive weeks followed by 1 week of rest.
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | Not described Receives: Drug: Benmelstobart+ Anlotinib+ Platinum + Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) (per RECIST Version 1.1)
Defined as complete response and partial response (CR+PR).The efficacy of this study was determined according to Recist version 1.1 criteria.
Measured: up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large-Cell Neuroendocrine Carcinoma of the LungStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510594
- Sponsor's protocol ID
- E20260026
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as First-Line Treatment for Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07510594
- Acronym / sponsor ID
- E20260026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the Objective Response Rate (ORR) of Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma of the lung (LCNEC) and extrapulmonary neuroendocrine carcinoma (EP-NEC)
Detailed description
This study is a single-center, single-arm, phase II study designed to observe and evaluate Benmelstobart combined with Anlotinib and chemotherapy as first-line treatment for large-cell neuroendocrine carcinoma (LCNEC) of the lung and extrapulmonary neuroendocrine carcinoma (EP-NEC).
Enrolled patients are those with histologically or pathologically confirmed metastatic LCNEC or EP-NEC (AJCC 9th edition) who have not received systemic treatment. Eligible subjects will receive 4 cycles of Benmelstobart combined with Anlotinib and chemotherapy, followed by maintenance treatment with Benmelstobart combined with Anlotinib, with continuous medication until disease progression or intolerable toxicity. The purpose of this study is to evaluate the efficacy and safety of Benmelstobart Injection combined with Anlotinib Hydrochloride and chemotherapy as first-line treatment for advanced LCNEC and EP-NEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Drug: Benmelstobart+ Anlotinib+ Platinum + Etoposide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed metastatic LCNEC or EP-NEC (per AJCC 9th Edition);
- No prior systemic treatment for locally advanced or metastatic LCNEC or EP-NEC; For patients who have received adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy for non-metastatic disease with curative intent, or definitive chemoradiotherapy for locally advanced disease, the interval from the end of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of metastatic NEC must be at least 6 months (calculated from the end date of the last chemotherapy cycle or the end date of the last radiotherapy);
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Lesions that have received prior radiotherapy can be considered measurable only if there is clear progression after radiotherapy and they are not the only lesion;
- Aged 18-75 years;
- ECOG Performance Status 0-1;
Key exclusion criteria (26 listed)
- Patients with brain metastasis and/or carcinomatous meningitis (excluding asymptomatic patients or patients with stable condition who have no imaging evidence of new/enlarged central nervous system metastasis for at least 2 weeks after brain metastasis treatment and have discontinued steroids or anticonvulsants for at least 14 days before the study; If active or new untreated asymptomatic central nervous system metastasis is detected during the screening phase, subjects must receive radiotherapy, or have no imaging evidence of new/enlarged brain metastasis for at least 2 weeks without treatment);
- Prior use of anti-angiogenic drugs such as Anlotinib, Apatinib, Bevacizumab, or immunotherapeutic drugs targeting PD-1, PD-L1, etc.;
- History of other malignant tumors within 5 years (except cured carcinoma in situ of the cervix or basal cell carcinoma of the skin);
- Factors affecting oral drug administration (dysphagia, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.);
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benmelstobart+ Anlotinib+ Platinum + EtoposideTreatment phase (intensive combination treatment) : 4 cycles, with each treatment cycle lasting 21 days: 1) Benmelstobart: 1200mg per dose, administered intravenously (IV) once every 21 days; 2) Anlotinib: 12mg per dose, taken orally (po) for 2 consecutive weeks followed by 1 week of rest; 3) Carboplatin: administered on Day 1, with an AUC of 5mg/mL/min via IV infusion (maximum dose: 750mg); \& Cisplatin: administered on Day 1, 75-80mg/m² via IV infusion; 4) Etoposide: administered continuously on Days 1, 2, and 3, 100mg/m² via IV infusion; Maintenance phase: 1) Maintenance treatment will be continued until loss of clinical benefit, intolerable toxicity, efficacy evaluation of PD, or judgment by the investigator that continued medication is inappropriate; 2) Benmelstobart: 1200mg per dose, administered IV once every 21 days; 3) Anlotinib: 12mg per dose, taken orally for 2 consecutive weeks followed by 1 week of rest. | Drug | experiment |
Primary outcome
Objective Response Rate (ORR) (per RECIST Version 1.1)
Time frame: up to 12 months.
Defined as complete response and partial response (CR+PR).The efficacy of this study was determined according to Recist version 1.1 criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benmelstobart+ Anlotinib+ Platinum + Etoposide in people with Large-Cell Neuroendocrine Carcinoma of the Lung and Extrapulmonary Neuroendocrine Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhansheng Jiang (008618526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (per RECIST Version 1.1) (time frame: up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.