Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer
Summary
Phase 2 clinical trial NCT07538258 registered at Shanghai Pulmonary Hospital, Tongji University, evaluating benmelstobart (immunotherapy) plus anlotinib (anti-angiogenic) combined with platinum-etoposide chemotherapy and concurrent thoracic radiotherapy as first-line treatment for previously untreated, unresectable limited-stage small cell lung cancer. The single-arm, single-center exploratory study enrolling 18-75 year old participants with measurable disease will assess objective response rate as primary endpoint, with secondary endpoints including progression-free survival, overall survival, and safety. Study completion is targeted for April 20, 2026.
What changed
A Phase 2 clinical trial registration for NCT07538258 has been added to ClinicalTrials.gov, documenting a single-arm study evaluating the combination of benmelstobart (PD-L1 inhibitor immunotherapy), anlotinib (VEGFR inhibitor), and standard platinum-etoposide chemotherapy with concurrent thoracic radiotherapy (60-70 Gy) as first-line treatment for limited-stage small cell lung cancer.
Affected parties include pharmaceutical companies developing immunotherapy or anti-angiogenic agents for lung cancer indications, contract research organizations conducting similar combination-regimen trials, and clinical investigators designing next-generation SCLC treatment protocols. Sponsors submitting related trial data to FDA should ensure alignment with this trial's safety endpoints as the competitive landscape for LS-SCLC combination therapies evolves.
Archived snapshot
Apr 21, 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.
Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer
Phase 2 NCT07538258 Kind: PHASE2 Apr 20, 2026
Abstract
This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC).
Eligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function.
Participants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on / 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects.
The primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety asse...
Conditions: Limited-stage Small Cell Lung Cancer (LS-SCLC)
Interventions: Benmelstobart, Anlotinib, Cisplatin or carboplatin, Etoposide, Thoracic Radiation Therapy
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