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

NCT07538271 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • SCLC, Extensive Stage

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • Yayi He

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-09-30
Completion
2029-03-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538271 on ClinicalTrials.gov