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

ConditionLimited-stage Small Cell Lung Cancer (LS-SCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYayi He

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: Histologically or cytologically confirmed inoperable limited-stage small cell lung cancer (LS-SCLC) (per VALG staging).

Disqualifiers

1: Prior use of anti-angiogenic agents such as anlotinib, apatinib, bevacizumab, or related immunotherapeutic agents targeting PD-1, PD-L1, etc

Trial design

Design model

Single group

Treatments tested in this trial

  • Benmelstobart

    Drug

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

  • Anlotinib

    Drug

    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

    Drug

    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

    Drug

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

  • Thoracic Radiation Therapy

    Radiation

    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.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Benmelstobart combined with anlotinib and chemotherapy concurrent with thoracic radiotherapyExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Investigator-Assessed Objective Response Rate

According to RECIST 1.1 criteria, investigator assesses target lesion changes via imaging; calculates the proportion of subjects achieving complete response (CR) or partial response (PR)

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

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
2

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
3

Immune-Related Adverse Event (irAE)

Identify and grade organ-specific immune-related adverse events according to CTCAE 5.0 and irAE criteria

Time frame
From date of first study drug administration through 90 days after the last dose of study drug; assessed at baseline, each cycle visit, and unscheduled visits for suspected irAEs; graded per CTCAE 5.0 and irAE-specific criteria.
4

Progression-Free Survival (PFS)

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

Time frame
From date of first study drug administration until the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first; assessed up to 24 months (maximum follow-up period).

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

Source ClinicalTrials.gov

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