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NOT YET RECRUITING
NCT07538271
PHASE2

A Study of Benmelstobart, Anlotinib, Chemotherapy and Thoracic Radiotherapy for People With Extensive-stage Small Cell Lung Cancer

Sponsor: Yayi He

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-arm, Exploratory Clinical Study of Benmelstobart Combined With Anlotinib and Chemotherapy Followed by Thoracic Radiotherapy as First-line Treatment for Extensive-stage Small Cell Lung Cancer (ES-SCLC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-04-20

Completion Date

2029-03-31

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

benmelstobart

A PD-L1 inhibitor (biological product) administered intravenously. Used for immunotherapy in combination with other agents to treat extensive-stage small cell lung cancer (ES-SCLC).

DRUG

Anlotinib

A small-molecule anti-angiogenic drug administered orally. Inhibits tumor angiogenesis to suppress tumor growth, used as part of the first-line combined therapy for ES-SCLC.

DRUG

Carboplatin or cisplatin

A platinum-based chemotherapeutic agent administered intravenously.

DRUG

Etoposide

A topoisomerase II inhibitor administered intravenously. Works by interfering with tumor cell replication, combined with platinum agents as first-line chemotherapy for ES-SCLC.

RADIATION

Thoracic Radiotherapy

External beam radiation therapy delivered to the thoracic region. Administered as consolidative treatment for non-progressive ES-SCLC patients after induction therapy, with a total dose based on clinical practice guidelines.