Non-small Cell Lung Cancer MetastaticDEEP-Lung-IVNCT04994795
Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer Metastatic, run by Sophia Genetics SAS at 30 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Predictive models (data collection)
- How many people
- 4,000 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 21 Aug 2021to Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
France9 sites
Avicenne Hospital
Bobigny, 93000
CHU Bordeaux
Bordeaux
Ambroise Paré Hospital
Boulogne-Billancourt, 92100
Hospices Civils de Lyon
Lyon, 69002
CHU de Nantes
Nantes, 44093
La Pitié Salpêtrière
Paris, 75013
Tenon Hospital
Paris, 75020
Foch Hospital
Suresnes, 92150
Centre Hospitalier de Toulon
Toulon, 83100
United States6 sites
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
Holden Comprehensive Cancer Center at University of Iowa Health Care
Iowa City, Iowa, 52242
Carbone Comprehensive Cancer Center at University of Wisconsin
Madison, Wisconsin, 53705
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
UMASS Memorial Health
Worcester, Massachusetts, 01655
Brazil5 sites
DASA - Hospital Brasilia
Brasília, 71681-603
DASA - Hospital de Niteroi
Niterói, 24020-096
DASA - Hospital São Lucas
Rio de Janeiro, 22061-080
DASA - Hospital Nove De Julho
São Paulo, 01409-902
AC Camargo
São Paulo
Italy3 sites
University Hospital Of Parma
Parma, 43100
Policlinico Gemelli
Roma
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
Udine, 33100
Spain3 sites
Fundacion jimenez diaz
Madrid, 28040
Puerta De Hierro Hospital
Madrid, 28222
Instituto Valenciano De Oncologia
Valencia, 46009
Israel2 sites
Shaare Zadek Medical Center
Jerusalem
Sourasky Medical Center
Tel Aviv
About this study
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
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
- Being tested
- Predictive models (data collection)
- Keywords
- NSCLC, Immunotherapy, Chemotherapy, Predictive models, Radiomics, Multimodal, Genomics, Machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Predictive models (data collection)Other
Machine learning predictive models
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab monotherapy | Not described Receives: Other: Predictive models (data collection) | |
| Chemotherapy and pembrolizumab combination therapy | Not described Receives: Other: Predictive models (data collection) | |
| Chemotherapy doublet | Not described Receives: Other: Predictive models (data collection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response at first evaluation
Predict treatment response at first evaluation using baseline data
Measured: 6-12 weeks after treatment start
Secondary outcomes (4)
Progression-Free Survival
Predict Progression-Free Survival (PFS) using data at baseline and first evaluation
Measured: Through study completion, expected 6-14 months contingent on cohort
Overall Survival
Predict Overall Survival (OS) using data at baseline and first evaluation
Measured: Through study completion, expected 8-20 months contingent on cohort
Duration of Response
Predict Duration of Response (DoR) using data at baseline and first evaluation
Measured: Through study completion, expected 6-14 months contingent on cohort
Time-To-Progression
Predict Time-To-Progression (TTP) using data at baseline and first evaluation
Measured: Through study completion, expected 6-14 months contingent on cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start21 Aug 2021
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophia Genetics SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Menu, MD-PhD, MBA, Study director, SOPHiA GENETICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994795
- Sponsor's protocol ID
- SGDLIV
- Acronym
- DEEP-Lung-IV
- Status last verified
- Nov 2024
- First submitted
- 15 Jul 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04994795
- Acronym / sponsor ID
- DEEP-Lung-IV / SGDLIV
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- NSCLC, Immunotherapy, Chemotherapy, Predictive models, Radiomics, Multimodal, Genomics, Machine learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Sophia Genetics SASIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab monotherapy | – | Other: Predictive models (data collection) |
| Chemotherapy and pembrolizumab combination therapy | – | Other: Predictive models (data collection) |
| Chemotherapy doublet | – | Other: Predictive models (data collection) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Predictive models (data collection)Machine learning predictive models | Other | Chemotherapy and pembrolizumab combination therapy, Chemotherapy doublet, Pembrolizumab monotherapy |
Primary outcome
Treatment response at first evaluation
Time frame: 6-12 weeks after treatment start
Predict treatment response at first evaluation using baseline data
4 secondary outcomes
Progression-Free Survival
Time frame: Through study completion, expected 6-14 months contingent on cohort
Overall Survival
Time frame: 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
Time-To-Progression
Time frame: Through study completion, expected 6-14 months contingent on cohort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Menu, MD-PhD, MBA study director
SOPHiA GENETICS
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Metastatic, run by Sophia Genetics SAS at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, United States, Brazil, Italy, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response at first evaluation (time frame: 6-12 weeks after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.