Clinical trial NCT04994795: Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer Metastatic
Keywords: NSCLC
Immunotherapy
Chemotherapy
Predictive models
Radiomics
Multimodal
Genomics
Machine learning
Lead sponsor: Sophia Genetics SAS
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment response at first evaluation
timeFrame: 6-12 weeks after treatment start
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: Through study completion, expected 6-14 months contingent on cohort
measure: Overall Survival
timeFrame: Through study completion, expected 8-20 months contingent on cohort
measure: Duration of Response
timeFrame: Through study completion, expected 6-14 months contingent on cohort
measure: Time-To-Progression
timeFrame: Through study completion, expected 6-14 months contingent on cohort
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa Health Care
state: Iowa
city: Worcester
country: United States
facility: UMASS Memorial Health
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Madison
country: United States
facility: Carbone Comprehensive Cancer Center at University of Wisconsin
state: Wisconsin
city: Brasília
country: Brazil
facility: DASA - Hospital Brasilia
city: Niterói
country: Brazil
facility: DASA - Hospital de Niteroi
city: Rio de Janeiro
country: Brazil
facility: DASA - Hospital São Lucas
city: São Paulo
country: Brazil
facility: DASA - Hospital Nove De Julho
city: São Paulo
country: Brazil
facility: AC Camargo
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre Toronto
city: Bobigny
country: France
facility: Avicenne Hospital
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré Hospital
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: La Pitié Salpêtrière
city: Paris
country: France
facility: Tenon Hospital
city: Suresnes
country: France
facility: Foch Hospital
city: Toulon
country: France
facility: Centre Hospitalier de Toulon
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Jerusalem
country: Israel
facility: Shaare Zadek Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Parma
country: Italy
facility: University Hospital Of Parma
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
city: Madrid
country: Spain
facility: Fundacion jimenez diaz
city: Madrid
country: Spain
facility: Puerta De Hierro Hospital
city: Valence
country: Spain
facility: Instituto Valenciano De Oncologia
Study officials:
affiliation: SOPHiA GENETICS
name: Philippe Menu, MD-PhD, MBA
role: STUDY_DIRECTOR
References: