Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)

NCT06558903 | Active Not Recruiting

• 1 other identifier: 29BRC21.0110 - HYPE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples

Conditions

Small Cell Lung Carcinoma

Keywords

Biomarker; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients

  Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders

  3 year

Secondary Outcomes (2)

• Progression-free survival

  3 year

• Overall survival

  3 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who started a first line treatment with atezolizumab plus carboplatin and etoposide at Brest University Hospital before February 2021 with available tumor sample before treatment start

You may qualify if:

• Patients with extensive or metastatic small cell lung cancer
• Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
• Patients with available tumor sample before treatment start
• No objection from living patients

You may not qualify if:

• Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
• Patients having received immunotherapy in a clinical trial
• Patients with auto-immune disorder
• Patients under legal protection (guardianship, curatorship)
• Patients refusing to participate to the study

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Margaux Geier, MD

  Department of Medical Oncology, Brest University Hospital

  STUDY DIRECTOR

• Pierre Le Noac'h, MD

  Department of Medical Oncology, Brest University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 19, 2024
• Study Start: June 24, 2021
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. requestors will be required to sign and complete a data access agreement

Locations

FR (1)