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

NCT04994795 | Active Not Recruiting DMC

• 1 other identifier: SGDLIV
• Study Type: observational
• Target: 4,000
• Locations: 8 countries
• Sites: 30

Brief 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.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

NSCLC; Immunotherapy; Chemotherapy; Predictive models; Radiomics; Multimodal; Genomics; Machine learning

Outcome Measures

Primary Outcomes (1)

• Treatment response at first evaluation

  Predict treatment response at first evaluation using baseline data

  6-12 weeks after treatment start

Secondary Outcomes (4)

• Progression-Free Survival

  Through study completion, expected 6-14 months contingent on cohort

• Overall Survival

  Through study completion, expected 8-20 months contingent on cohort

• Duration of Response

  Through study completion, expected 6-14 months contingent on cohort

• Time-To-Progression

  Through study completion, expected 6-14 months contingent on cohort

Study Arms (3)

Pembrolizumab monotherapy

Other: Predictive models (data collection)

Chemotherapy and pembrolizumab combination therapy

Other: Predictive models (data collection)

Chemotherapy doublet

Other: Predictive models (data collection)

Interventions

Predictive models (data collection) OTHER

Machine learning predictive models

Chemotherapy and pembrolizumab combination therapy; Chemotherapy doublet; Pembrolizumab monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sophia Genetics SAS: lead

Study Sites (30)

Holden Comprehensive Cancer Center at University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

UMASS Memorial Health

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Carbone Comprehensive Cancer Center at University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

DASA - Hospital Brasilia

Brasília, 71681-603, Brazil

Location

DASA - Hospital de Niteroi

Niterói, 24020-096, Brazil

Location

DASA - Hospital São Lucas

Rio de Janeiro, 22061-080, Brazil

Location

DASA - Hospital Nove De Julho

São Paulo, 01409-902, Brazil

Location

AC Camargo

São Paulo, Brazil

Location

Sunnybrook Health Sciences Centre Toronto

Toronto, Canada

Location

Avicenne Hospital

Bobigny, 93000, France

Location

CHU Bordeaux

Bordeaux, France

Location

Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

Location

Hospices Civils de Lyon

Lyon, 69002, France

Location

CHU de Nantes

Nantes, 44093, France

Location

La Pitié Salpêtrière

Paris, 75013, France

Location

Tenon Hospital

Paris, 75020, France

Location

Foch Hospital

Suresnes, 92150, France

Location

Centre Hospitalier de Toulon

Toulon, 83100, France

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Shaare Zadek Medical Center

Jerusalem, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

University Hospital Of Parma

Parma, 43100, Italy

Location

Policlinico Gemelli

Roma, Italy

Location

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

Udine, 33100, Italy

Location

Fundacion jimenez diaz

Madrid, 28040, Spain

Location

Puerta De Hierro Hospital

Madrid, 28222, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Philippe Menu, MD-PhD, MBA

  SOPHiA GENETICS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: August 6, 2021
• Study Start: August 21, 2021
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

IT (3); CA (1); IL (2); DE (1); FR (9); US (6); BR (5); ES (3)