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Benmelstobart Plus Anlotinib, Chemotherapy and Thoracic Radiation for Limited-Stage Small Cell Lung Cancer

NCT07538258 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

RADIATION

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.

DRUG

Benmelstobart

Anti-PD-L1 monoclonal antibody, immunotherapy.1200 mg/dose, Q21D (1 cycle), IV infusion.

DRUG

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.

DRUG

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.

DRUG

Etoposide

Chemotherapy agent. Days 1-3, 100 mg/m², IV infusion.

Sponsors & Collaborators

  • 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 NCT07538258 on ClinicalTrials.gov