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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer Metastatic
• Intervention / Treatment: Other: Predictive models (data collection)

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

Study Locations

• Brazil
  • Brasília, Brazil, 71681-603
    • DASA - Hospital Brasilia
  • Niterói, Brazil, 24020-096
    • DASA - Hospital de Niteroi
  • Rio de Janeiro, Brazil, 22061-080
    • DASA - Hospital São Lucas
  • São Paulo, Brazil
    • AC Camargo
  • São Paulo, Brazil, 01409-902
    • DASA - Hospital Nove de Julho
• Canada
  • Toronto, Canada
    • Sunnybrook Health Sciences Centre Toronto
• France
  • Bobigny, France, 93000
    • Avicenne Hospital
  • Bordeaux, France
    • CHU Bordeaux
  • Boulogne-Billancourt, France, 92100
    • Ambroise Paré Hospital
  • Lyon, France, 69002
    • Hospices Civils de Lyon
  • Nantes, France, 44093
    • CHU de Nantes
  • Paris, France, 75020
    • Tenon Hospital
  • Paris, France, 75013
    • La Pitié Salpêtrière
  • Suresnes, France, 92150
    • Foch Hospital
  • Toulon, France, 83100
    • Centre Hospitalier de Toulon
• Germany
  • Leipzig, Germany, 04103
    • University Hospital Leipzig
• Israel
  • Jerusalem, Israel
    • Shaare Zadek Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
• Italy
  • Parma, Italy, 43100
    • University Hospital of Parma
  • Roma, Italy
    • Policlinico Gemelli
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
• Spain
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28222
    • Puerta de Hierro Hospital
  • Valence, Spain, 46009
    • Instituto Valenciano de Oncologia
• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Holden Comprehensive Cancer Center at University of Iowa Health Care
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Comprehensive Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Carbone Comprehensive Cancer Center at University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients diagnosed with stage IV NSCLC (de novo or earlier stage progression to stage IV), without oncogene-activating mutations eligible for targeted therapy, that are treated in the first-line setting with either pembrolizumab monotherapy, chemotherapy and pembrolizumab combination therapy, or chemotherapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pembrolizumab monotherapy	Other: Predictive models (data collection); Machine learning predictive models
Chemotherapy and pembrolizumab combination therapy	Other: Predictive models (data collection); Machine learning predictive models
Chemotherapy doublet	Other: Predictive models (data collection); Machine learning predictive models

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response at first evaluation	Predict treatment response at first evaluation using baseline data	6-12 weeks after treatment start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall Survival	Predict Overall Survival (OS) using data at baseline and first evaluation	Through study completion, expected 8-20 months contingent on cohort
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
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

Collaborators and Investigators

• Sponsor: Sophia Genetics SAS
• Investigators: Study Director: Philippe Menu, MD-PhD, MBA, SOPHiA GENETICS

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; Immunotherapy; Chemotherapy; Genomics; Machine learning; Radiomics; Multimodal; Predictive models
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SGDLIV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No