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

November 20, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Oncología
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sophia Genetics SAS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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