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NCT Number: NCT07070011

Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer

This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies.

A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.

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Key information

Conditions

Extensive-stage Small Cell Lung Cancer (ES-SCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Requirements for patients enrolled in the project:

  • The pathological diagnosis of the patient is ESSCLC;
  • ECOG score 0 or 1；
  • The patient is receiving immunotherapy combined with chemotherapy for the first time and has no history of chemotherapy treatment;
  • Patients with complete clinical sample information who meet the inclusion requirements

Exclusion criteria

  • Patients whose pathological diagnosis does not meet the requirements;
  • Patients whose ECOG staging does not meet the requirements;
  • Patients with a history of chemotherapy, immunotherapy, or immunotherapy combined with chemotherapy;
  • Patients with incomplete clinical sample information and follow-up information;

Treatment and study plan

EC/EP + ICIs

Combination Product

Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.

Primary outcomes

  1. Tumor Response Status per RECIST 1.1

    Time frame: 6 to 8 weeks

    • Assessment Tool: RECIST 1.1 criteria ;
    • Unit of Measure: Number of patients (n) and percentage (%) ;
    • Data Aggregation Method: Calculation of proportions of patients in each response category (PR/SD/PD);

    Definitions:

    • Partial Response (PR): ≥30% reduction in the sum of diameters of target lesions from baseline (absence of new lesions) ;
    • Stable Disease (SD): Change in the sum of diameters ranging from <30% reduction to <20% increase (absence of new lesions) ;
    • Progressive Disease (PD): ≥20% increase in the sum of diameters (reference: smallest sum recorded) and/or appearance of new lesions ;

  2. Baseline Serum sEV miRNA Expression Levels

    Time frame: Baseline (pre-treatment)

    • Measurement Tool: Next-generation sequencing (NGS) ;
    • Unit of Measure: Standardized expression values (CPM, Counts Per Million) ;
    • Data Aggregation Method: Descriptive statistics (mean ± SD or median [IQR]) of expression levels by response groups ;
    • Procedure:
    • Pre-treatment serum collection ;
    • sEV isolation ;
    • miRNA extraction ;
    • NGS sequencing ;
    • Bioinformatic normalization (CPM) .

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhang, MD

CONTACT

[email protected]

+86-021-62821990

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital of Shanghai Jiao Tong University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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