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

April 15, 2024 updated by: Sophia Genetics SAS

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Brasília, Brazil, 71681-603
        • Recruiting
        • DASA - Hospital Brasilia
        • Principal Investigator:
          • Fernando De Padua, MD
      • Niterói, Brazil, 24020-096
        • Recruiting
        • DASA - Hospital de Niteroi
        • Principal Investigator:
          • Victor Araujo MACHADO, MD
      • Rio de Janeiro, Brazil, 22061-080
        • Recruiting
        • DASA - Hospital São Lucas
        • Principal Investigator:
          • Luiz Henrique DE LIMA ARAÚJO, MD, PhD
      • São Paulo, Brazil, 01409-902
        • Recruiting
        • DASA - Hospital Nove De Julho
        • Contact:
          • Mariana Scaranti, MD
      • São Paulo, Brazil
        • Recruiting
        • AC Camargo
        • Contact:
          • Almir BITENCOURT, MD
  • Canada
  • France
  • Germany
  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Shaare Zadek Medical Center
        • Contact:
        • Principal Investigator:
          • Nir Peled, MD
        • Sub-Investigator:
          • Laila Roisman, MD
      • Tel Aviv, Israel
        • Recruiting
        • Sourasky Medical Center
        • Contact:
          • Ofer Merimsky, Pr
        • Principal Investigator:
          • Ofer Merimsky, Pr
  • Italy
      • Parma, Italy, 43100
        • Recruiting
        • University Hospital Of Parma
        • Contact:
          • Nicola Sverzellati, MD
        • Principal Investigator:
          • Nicola Sverzellati, MD
      • Roma, Italy
        • Recruiting
        • Policlinico Gemelli
        • Contact:
          • Luca Boldrini, MD
      • Udine, Italy, 33100
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
        • Contact:
          • Giacomo Pelizzari, MD
        • Principal Investigator:
          • Giacomo Pelizzari, MD
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Fundacion Jimenez Diaz
        • Contact:
          • Manuel Domine Gomez, MD
        • Principal Investigator:
          • Manuel Domine Gomez, MD
      • Madrid, Spain, 28222
        • Recruiting
        • Puerta de Hierro Hospital
        • Principal Investigator:
          • Mariano Provencio, MD
        • Contact:
          • Mariano Provencio, Pr
      • Valence, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
          • Eugenio Sanchez Aparisi, MD
        • Principal Investigator:
          • Eugenio Sanchez Aparisi, MD
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Holden Comprehensive Cancer Center at University of Iowa Health Care
        • Contact:
    • Massachusetts
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Aaron Mansfield, MD
        • Principal Investigator:
          • Aaron Mansfield, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
        • Principal Investigator:
          • Prantesh Jain, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
          • Wallace Akerley, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • Carbone Comprehensive Cancer Center at University of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

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
Time Frame: 6-12 weeks after treatment start
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
Time Frame: Through study completion, expected 6-14 months contingent on cohort
Predict Progression-Free Survival (PFS) using data at baseline and first evaluation
Through study completion, expected 6-14 months contingent on cohort
Overall Survival
Time Frame: Through study completion, expected 8-20 months contingent on cohort
Predict Overall Survival (OS) using data at baseline and first evaluation
Through study completion, expected 8-20 months contingent on cohort
Duration of Response
Time Frame: Through study completion, expected 6-14 months contingent on cohort
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
Time Frame: Through study completion, expected 6-14 months contingent on cohort
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

This is where you will find people and organizations involved with this study.

Sponsor

Sophia Genetics SAS

Investigators

  • Study Director: Philippe Menu, MD-PhD, MBA, SOPHiA GENETICS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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