Benmelstobart, Anlotinib, and Chemotherapy for Extensive-stage Small Cell Lung Cancer
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered a Phase 2 single-center study at Shanghai Pulmonary Hospital evaluating benmelstobart plus anlotinib and platinum-etoposide chemotherapy with sequential thoracic radiotherapy in 33 adult patients with previously untreated extensive-stage small cell lung cancer. The open-label, non-randomized trial uses objective response rate as the primary endpoint.
What changed
A new clinical trial registration for a Phase 2 study of benmelstobart combined with anlotinib and standard chemotherapy for extensive-stage small cell lung cancer has been posted to ClinicalTrials.gov. The single-arm exploratory study will enroll 33 patients at Shanghai Pulmonary Hospital, assessing objective response rate as the primary endpoint.
Healthcare providers and clinical investigators involved in lung cancer research may use this registry entry to identify ongoing trials in this treatment space. The study's inclusion criteria (ECOG 0-1, measurable disease per RECIST 1.1) and four-cycle induction regimen followed by thoracic radiotherapy and maintenance therapy represent a typical immunotherapy-angiogenesis-chemotherapy combination approach for ES-SCLC.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer
Phase 2 NCT07538271 Kind: PHASE2 Apr 20, 2026
Abstract
This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity.
The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.
Conditions: SCLC, Extensive Stage
Interventions: benmelstobart, Anlotinib, Carboplatin or cisplatin, Etoposide, Thoracic Radiotherapy
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