Lung CancerIMMUNO-PREDICTNCT04918836
Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer
An observational study of Lung Cancer, run by University Hospital, Brest at 1 site in France.
Trial summary
A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2021to 8 Oct 2022
- 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 with metastatic non-small cell lung cancer receiving immunotherapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUMAB) regardless of the line of treatment in daily practice
Who may be able to join
- Major patient
- Metastatic non-small cell lung cancer
- Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
- No objection made
Who cannot join
- Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
- Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
- Patient with prior checkpoint inhibitor therapy
- Patient with a contraindication to immunotherapy
- Patient under legal protection
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Renaud Descourt contact
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Gilles QUERE, gilles.quere@chu-brest.fr
About this study
Official title: Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.
Read the detailed description
The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.
Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.
The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of biological markers of immunity under immunotherapy at 6 months
Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
Measured: Day 0 and month 6 (M6)
Secondary outcomes (8)
Impact on Overall Survival (OS) and Progression Free Survival (PFS)
Determine if the presence of biological markers of autoimmunity at initiation or during anti-PD1/PDL1 immunotherapy influences overall survival or progression-free survival.
Measured: Day 0 and Six month after (M6)
Impact on autoimmune toxicity
Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade).
Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade).
Measured: Day 0 and month 6 (M6)
Impact of complement
Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.
Measured: Day 0 and month 6 (M6)
Impact of autoimmune toxicity on OS
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's overall survival.
Measured: Day 0 and month 6 (M6)
Impact of autoimmune toxicity on PFS
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's progression-free survival.
Measured: Day 0 and month 6 (M6)
Impact of clinical factors
Determine if clinical factors (undernutrition, tumor mass, general condition) at initiation or during anti-PD1/PDL1 immunotherapy influence patient's overall survival and progression-free survival
Measured: Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile
Study the clinical factors influencing the immune profile
Measured: Day 0 and month 6 (M6)
Impact of CRP and lymphopenia
Determine if CRP and the presence of initial lymphopenia influence the presence or induction of an immunological abnormality
Measured: Day 0 and month 6 (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start8 Apr 2021
- Primary completion8 Oct 2021 (estimated)
- Study completion8 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918836
- Sponsor's protocol ID
- Immuno-PREDICT ( 29BRC21.0021)
- Acronym
- IMMUNO-PREDICT
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers
- ClinicalTrials.gov ID
- NCT04918836
- Acronym / sponsor ID
- IMMUNO-PREDICT / Immuno-PREDICT ( 29BRC21.0021)
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 8 Oct 2021 (estimated)
- Study completion
- 8 Oct 2022 (estimated)
- First posted
- 9 Jun 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.
A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.
Detailed description
The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.
Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.
The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic non-small cell lung cancer receiving immunotherapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUMAB) regardless of the line of treatment in daily practice
Key inclusion criteria (4 listed)
- Major patient
- Metastatic non-small cell lung cancer
- Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
- No objection made
Key exclusion criteria (6 listed)
- Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
- Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
- Patient with prior checkpoint inhibitor therapy
- Patient with a contraindication to immunotherapy
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of biological markers of immunity under immunotherapy at 6 months
Time frame: Day 0 and month 6 (M6)
Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
8 secondary outcomes
Impact on Overall Survival (OS) and Progression Free Survival (PFS)
Time frame: Day 0 and Six month after (M6)
Impact on autoimmune toxicity
Time frame: Day 0 and month 6 (M6)
Impact of complement
Time frame: Day 0 and month 6 (M6)
Impact of autoimmune toxicity on OS
Time frame: Day 0 and month 6 (M6)
Impact of autoimmune toxicity on PFS
Time frame: Day 0 and month 6 (M6)
Impact of clinical factors
Time frame: Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile
Time frame: Day 0 and month 6 (M6)
Impact of CRP and lymphopenia
Time frame: Day 0 and month 6 (M6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Renaud Descourt contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University Hospital, Brest at 1 site in France.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles QUERE (0298223740, gilles.quere@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of biological markers of immunity under immunotherapy at 6 months (time frame: Day 0 and month 6 (M6)). 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 9 Jun 2021.