Stage IV Non-small Cell Lung CancerNCT03305380
Radiomics to Identify Patients at Risk for Developing Pneumonitis, Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and Distinguish Tumour Pseudo-progression From Real Tumour Growth
An observational study of Stage IV Non-small Cell Lung Cancer, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
Trial summary
The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- How many people
- 637 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Sep 2017to 1 Apr 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer
Who may be able to join
- Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer
Who cannot join
- The opposite of the above
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Zuyderland Medical Center
Heerlen, 6419 PC
MUMC+
Maastricht, 6229 HX
About this study
Official title: Radiomics to 1. Identify Patients at Risk for Developing Pneumonitis, 2. Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and 3. Distinguish Tumour Pseudo-progression From Real Tumour Growth, in Patients With Non-small Cell Lung Cancer Treated With Anti-PD1 or Anti-PD-L1
The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
Read the detailed description
Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- No interventions
- Keywords
- anti-PD1, anti-PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
As this is a patient registry, there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a pulmonary event | (under anti-PD1 or anti-PD-L1) This is the first group of the retrospective part of the study. Receives: Other: No interventions | |
| Patients without a pulmonary event | (under anti-PD1 or anti-PD-L1) This is the second group of the retrospective part of the study. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cause of pneumonitis
Determining cause of the pneumonitis by medical status of the patient
Measured: 6 months
Secondary outcomes (1)
Predictive accuracy of radiomics for determining the cause of pneumonitis
Three subgroups of immune checkpoint induced pneumonitis:
- Immune checkpoint-induced pneumonitis from tumour progression
- Immune checkpoint-induced pneumonitis from other types of pneumonitis
- Patients with interstitial lung disease that are at risk to develop immune checkpoint-induced pneumonitis and those who are not.
Radiomics will be used to predict the cause of pneumonitis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Jan 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Non-small Cell Lung CancerStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 637 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Zuyderland Medical Centre
- Responsible party
- Sponsor
- Investigators
- Dirk De Ruysscher, MD, PhD, Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305380
- Sponsor's protocol ID
- BMS Radiomics
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics to 1. Identify Patients at Risk for Developing Pneumonitis, 2. Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and 3. Distinguish Tumour Pseudo-progression From Real Tumour Growth, in Patients With Non-small Cell Lung Cancer Treated With Anti-PD1 or Anti-PD-L1
- ClinicalTrials.gov ID
- NCT03305380
- Acronym / sponsor ID
- BMS Radiomics
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Keywords
- anti-PD1, anti-PD-L1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Zuyderland Medical Centre
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 10 Oct 2017 (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.
The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
Detailed description
Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).
On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a pulmonary event | – | Other: No interventions(under anti-PD1 or anti-PD-L1) This is the first group of the retrospective part of the study. |
| Patients without a pulmonary event | – | Other: No interventions(under anti-PD1 or anti-PD-L1) This is the second group of the retrospective part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer
Key inclusion criteria (1 listed)
- Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer
Key exclusion criteria (1 listed)
- The opposite of the above
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 |
|---|---|---|
| No interventionsAs this is a patient registry, there are no interventions. | Other | Patients with a pulmonary event, Patients without a pulmonary event |
Primary outcome
Cause of pneumonitis
Time frame: 6 months
Determining cause of the pneumonitis by medical status of the patient
1 secondary outcome
Predictive accuracy of radiomics for determining the cause of pneumonitis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Dirk De Ruysscher, MD, PhD principal investigator
Maastro Clinic, The Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IV Non-small Cell Lung Cancer, run by Maastricht Radiation Oncology at 2 sites in Netherlands.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cause of pneumonitis (time frame: 6 months). 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 16 Sep 2021.