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NCT04994795 Clinical Trial

Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Metastatic Clinical Trial

— DEEP-Lung-IV  

Official title:
Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04994795
Other study ID # SGDLIV
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 21, 2021
Est. completion date February 2025

Study information
Verified date April 2024
Source Sophia Genetics SAS
Contact Philippe Menu, MD-PhD, MBA
Phone +41216941060
Email DeepLungIV@sophiagenetics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date February 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult =18 years old - Patient diagnosed with Stage IV NSCLC (de novo or earlier stage progression to stage IV) - Absence of oncogene activating mutations eligible patients to targeted therapy (EGFR, ALK) - Cohort A: Received first line treatment with pembrolizumab monotherapy - Cohort B: Received first line treatment with chemotherapy and pembrolizumab combination therapy - Cohort C: Received first line treatment with chemotherapy doublet Exclusion Criteria: - Prior anti-cancer therapy for actual stage IV NSCLC - Critical data missing (e.g., PD-L1 status, baseline millimetric imaging, first evaluation millimetric imaging) - Patients participating in other clinical trials that modify the standard of care

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Predictive models (data collection)
Machine learning predictive models

Locations
Country Name City State
Brazil DASA - Hospital Brasilia Brasília
Brazil DASA - Hospital de Niteroi Niterói
Brazil DASA - Hospital São Lucas Rio de Janeiro
Brazil AC Camargo São Paulo
Brazil DASA - Hospital Nove De Julho São Paulo
Canada Sunnybrook Health Sciences Centre Toronto Toronto
France Avicenne Hospital Bobigny
France CHU Bordeaux Bordeaux
France Ambroise Paré Hospital Boulogne-Billancourt
France Hospices Civils de Lyon Lyon
France CHU de Nantes Nantes
France La Pitié Salpêtrière Paris
France Tenon Hospital Paris
France Foch Hospital Suresnes
France Centre Hospitalier de Toulon Toulon
Germany University Hospital Leipzig Leipzig
Israel Shaare Zadek Medical Center Jerusalem
Israel Sourasky Medical Center Tel Aviv
Italy University Hospital Of Parma Parma
Italy Policlinico Gemelli Roma
Italy Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) Udine
Spain Fundacion jimenez diaz Madrid
Spain Puerta De Hierro Hospital Madrid
Spain Instituto Valenciano De Oncologia Valence
United States Roswell Park Comprehensive Cancer Center Buffalo New York
United States Holden Comprehensive Cancer Center at University of Iowa Health Care Iowa City Iowa
United States Carbone Comprehensive Cancer Center at University of Wisconsin Madison Wisconsin
United States Mayo Clinic Rochester Minnesota
United States Huntsman Cancer Institute Salt Lake City Utah
United States UMASS Memorial Health Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Sophia Genetics SAS

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  France,  Germany,  Israel,  Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment response at first evaluation Predict treatment response at first evaluation using baseline data 6-12 weeks after treatment start
Secondary Progression-Free Survival Predict Progression-Free Survival (PFS) using data at baseline and first evaluation Through study completion, expected 6-14 months contingent on cohort
Secondary Overall Survival Predict Overall Survival (OS) using data at baseline and first evaluation Through study completion, expected 8-20 months contingent on cohort
Secondary Duration of Response Predict Duration of Response (DoR) using data at baseline and first evaluation Through study completion, expected 6-14 months contingent on cohort
Secondary Time-To-Progression Predict Time-To-Progression (TTP) using data at baseline and first evaluation Through study completion, expected 6-14 months contingent on cohort
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