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

ConditionSCLC, Extensive Stage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYayi He

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: Histologically or cytologically confirmed inoperable extensive-stage small cell lung cancer (ES-SCLC) according to the VALG staging system

Disqualifiers

1: Patients with symptomatic brain metastases. Patients whose brain metastases have been treated and remain clinically stable for at least 1 month, with no use of steroids or anticonvulsants for at least 1 month prior to study enrollment, are eligible

Trial design

Design model

Single group

Treatments tested in this trial

  • benmelstobart

    Drug

    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).

  • Anlotinib

    Drug

    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.

  • Carboplatin or cisplatin

    Drug

    A platinum-based chemotherapeutic agent administered intravenously.

  • Etoposide

    Drug

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

  • Thoracic Radiotherapy

    Radiation

    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.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Benmelstobart + Anlotinib + Chemotherapy Followed by Thoracic RadiotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with benmelstobart plus anlotinib and chemotherapy followed by thoracic radiotherapy.

Time frame
Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Time from first treatment to disease progression or death from any cause, whichever occurs first

Time frame
Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
2

Overall Survival (OS)

Time from first study treatment to death from any cause; censored at last follow-up for alive subjects

Time frame
From date of first study treatment to date of death from any cause or last follow-up, whichever occurs first, assessed up to approximately 24 months
3

6-Month Progression-Free Survival Rate

Estimated proportion of subjects without progression and alive at 6 months after first treatment using Kaplan-Meier method

Time frame
6-month time point after first treatment, follow-up cutoff
4

Serious Adverse Event (SAE)

Collect SAEs resulting in death, life-threatening condition, hospitalization, disability per CTCAE 5.0 and ICH-GCP, document and report

Time frame
from date of first study drug administration , follow-up until resolution or stabilization, assessed up to approximately 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yayi He

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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