A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC an… (NCT07510594) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC
China48 participantsStarted 2026-05-01
Plain-language 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)
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. 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;
Exclusion criteria
✕. 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);
What they're measuring
1
Objective Response Rate (ORR) (per RECIST Version 1.1)
Timeframe: up to 12 months.
Trial details
NCT IDNCT07510594
SponsorTianjin Medical University Cancer Institute and Hospital
✕. 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;
✕. 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;