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Recruiting NCT07070011

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

— Observational Extensive-stage Small Cell Lung Cancer (ES-SCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EC/EP + ICIs.
Who it may be relevant to
Registry conditions: Extensive-stage Small Cell Lung Cancer (ES-SCLC). Basic parameters: 45 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Combination product EC/EP + ICIs
    Collect blood samples from patients with small cell lung cancer before receiving immunotherapy combined with chemotherapy.

Primary outcome measures

  • Tumor Response Status per RECIST 1.1 [Time frame: 6 to 8 weeks]
  • Baseline Serum sEV miRNA Expression Levels [Time frame: Baseline (pre-treatment)]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT07070011 · IS2109-(LGZ)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗