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Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer
Sponsor: Yayi He
Summary
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 assessments of adverse events graded by CTCAE 5.0. A total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.
Official title: A Single-Arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Concurrent With Thoracic Radiotherapy as First-Line Treatment in Limited-Stage Small Cell Lung Cancer (LS-SCLC)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
27
Start Date
2026-04-20
Completion Date
2029-03-31
Last Updated
2026-04-20
Healthy Volunteers
No
Interventions
Benmelstobart
Anti-PD-L1 monoclonal antibody, immunotherapy.1200 mg/dose, Q21D (1 cycle), IV infusion.
Anlotinib
Small molecule multi-target anti-angiogenic agent.12 mg/day, oral (2 weeks on/1 week off, repeated Q3W), taken with water at fixed time.
Cisplatin or carboplatin
Chemotherapy agent.Carboplatin: Day 1, AUC 5 mg/mL/min (max 750 mg), IV infusion; Cisplatin: Day 1, 75-80 mg/m², IV infusion.
Etoposide
Chemotherapy agent. Days 1-3, 100 mg/m², IV infusion.
Thoracic Radiation Therapy
External beam intensity-modulated radiotherapy (IMRT) targeting the primary thoracic tumor, ipsilateral hilum, and mediastinal lymph node stations (per LS-SCLC staging guidelines). Initiated with Cycle 1 of chemotherapy; IMRT, 60-70 Gy in 30-35 fractions (1.8-2.0 Gy/fraction, once daily); target volumes: primary tumor + lymph nodes delineated on post-chemotherapy CT, investigator-adjusted individually.