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

NCT ID: NCT04994795

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-21

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Pembrolizumab monotherapy

Predictive models (data collection)

Intervention Type OTHER

Machine learning predictive models

Chemotherapy and pembrolizumab combination therapy

Predictive models (data collection)

Intervention Type OTHER

Machine learning predictive models

Chemotherapy doublet

Predictive models (data collection)

Intervention Type OTHER

Machine learning predictive models

Interventions

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Predictive models (data collection)

Machine learning predictive models

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sophia Genetics SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Menu, MD-PhD, MBA

Role: STUDY_DIRECTOR

SOPHiA GENETICS

Locations

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Holden Comprehensive Cancer Center at University of Iowa Health Care

Iowa City, Iowa, United States

Site Status

UMASS Memorial Health

Worcester, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Carbone Comprehensive Cancer Center at University of Wisconsin

Madison, Wisconsin, United States

Site Status

DASA - Hospital Brasilia

Brasília, , Brazil

Site Status

DASA - Hospital de Niteroi

Niterói, , Brazil

Site Status

DASA - Hospital São Lucas

Rio de Janeiro, , Brazil

Site Status

DASA - Hospital Nove De Julho

São Paulo, , Brazil

Site Status

AC Camargo

São Paulo, , Brazil

Site Status

Sunnybrook Health Sciences Centre Toronto

Toronto, , Canada

Site Status

Avicenne Hospital

Bobigny, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

Ambroise Paré Hospital

Boulogne-Billancourt, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

La Pitié Salpêtrière

Paris, , France

Site Status

Tenon Hospital

Paris, , France

Site Status

Foch Hospital

Suresnes, , France

Site Status

Centre Hospitalier de Toulon

Toulon, , France

Site Status

University Hospital Leipzig

Leipzig, , Germany

Site Status

Shaare Zadek Medical Center

Jerusalem, , Israel

Site Status

Sourasky Medical Center

Tel Aviv, , Israel

Site Status

University Hospital Of Parma

Parma, , Italy

Site Status

Policlinico Gemelli

Roma, , Italy

Site Status

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, , Italy

Site Status

Fundacion jimenez diaz

Madrid, , Spain

Site Status

Puerta De Hierro Hospital

Madrid, , Spain

Site Status

Instituto Valenciano De Oncologia

Valencia, , Spain

Site Status

Countries

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United States Brazil Canada France Germany Israel Italy Spain

Other Identifiers

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SGDLIV

Identifier Type: -

Identifier Source: org_study_id

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