Non-small Cell Lung CancerNCT03870464
LIFE - Lung Cancer, Immunotherapy, Frailty, Effect
An observational study of Non-small Cell Lung Cancer and Quality of Life, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Quality of Life, Brain Metastases
- What is being tested?
- CT-scans extended, MRI scan of the brain and Prospective registration of irAEs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2018to 1 Apr 2028
- 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: A total of 150 patients with incurable advanced (stage III A-C) or metastatic (stage IV) non-small cell lung cancer eligible for treatment with ICI at a Danish Hospital (Odense, Denmark). All possible treatment lines are allowed. ICI administered as nivolumab, pembrolizumab or atezolisumab.
Who may be able to join
- Age > 18 years
- Stage IV NSCLC or recurrent NSCLC.
- Squamous or non-squamous histology
- Any treatment-line - Independent of prior treatment
- Candidate for checkpoint inhibitor (PD-1/PD-L1 targeting agents) immunotherapy
- No previously known allergy to PD-1/PD-L1 targeting agents.
- Able to give written consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Age and Comorbidity on Effect of Treatment, Adverse Effects and Quality of Life in Danish Lung Cancer Patients Receiving Immunotherapy
The LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition.
Read the detailed description
The era of immune checkpoint inhibition (ICI) has changed the treatment regimen for incurable non-small cell lung cancer. With that the hope of a more long-term survival has been introduced. ICI is given as standard therapy for selected NSCLC patients with incurable advanced or metastatic (stage IV) disease. For this group of patients clinical trial reports present a 3 year overall survival rate of around 30%. Checkpoint inhibition is also known as programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors and the PD-L1 tumor proportion score is currently the only clinically applicable biomarker used for this patient selection. New prognostic and predictive biomarkers are therefore warranted.The real life unselected NSCLC patient eligible for treatment with immunotherapy (check point inhibition) may be both older, with more comorbidity, more widespread disease and in poorer performance status than patients treated in clinical phase III trials. In this prospective single center study, clinical patient data, peripheral blood and baseline pre-treatment tumor biopsies are collected from NSCLC patients treated in any given treatment line with nivolumab, pembrolizumab or atezolizumab. Besides baseline samples consecutive blood samples will be collected for cytokine profiling and measurement of circulating tumor DNA (ctDNA) and micro RNA analysis. Baseline MRI of the brain screening for brain metastases and an extended CT-scan of thorax, abdomen and the lower extremities will be performed screening for venous thromboembolism (VTE). This along with comorbidity screening tools and quality of life assessments will provide detailed mapping of both patient and disease characteristics of potentially more frail patients including those with untreated brain metastases. By also registering immune related adverse events (irAE) prospectively in this study and doing additional blood samples in case of grade 3-4 toxicity, identification of biomarkers as predictors for effect and toxicity is durable. Hopefully this will contribute to more optimized treatment courses for those NSCLC patients to come.
- Being tested
- CT-scans extended, MRI scan of the brain, Prospective registration of irAEs, Quality of Life questionnaires
- Keywords
- non-small cell lung cancer, immunotherapy, checkpoint inhibition, biomarkers, quality of life, real life patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scans extendedDiagnostic test
CT scans of thorax, abdomen and lower extremities are performed - screening for venous trombolisms at baseline and at 6 months in each patient. If VTE is diagnosed, medications according to guidelines will be administered.
MRI scan of the brainDiagnostic test
MRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease.
Prospective registration of irAEsOther
irAEs are registered according to Common Terminology Criteria for Adverse Events version 4.0 by a medical doctor or trained experienced clinical nurse.
Quality of Life questionnairesBehavioural
Participants fill out two Quality of Life questionnaires. The European Organization of Research and Treatment of Cancer, Quality of Life -30 questionnaire (EORTC QoL-30) and the European Questionnaire - 5 dimensions-5-level questionnaire (Euro EQ-5D-5L).
| Study group | Role | What they receive |
|---|---|---|
| Prospective arm | Quality of Life questionnaires EORTC-QoL30 and Euro EQ-5D-5L questionnaires are distributed. Blood samples are collected consecutively during ICI and at a follow-up period of one year. CT-scans extended of thorax, abdomen and the lower extremities are performed at baseline and at 6 months. MRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease.Prospective registration of irAEs are registered during ICI and for one year of follow-up.Enrolment period 1th of April 2018- 31th of April 2021. Receives: Diagnostic Test: CT-scans extended; Diagnostic Test: MRI scan of the brain; Other: Prospective registration of irAEs; Behavioral: Quality of Life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with CTCAE 4.0 toxicity registered Immune related autoimmune events (irAE).
Number of patients with CTCAE 4.0 toxicity registered according to age, comorbidity and predictive biomarkers.
Measured: ICI will be given for a maximum of 24 months, and irAE registered up till one year post ICI treatment, which is anticipated to be within 4 years after of start inclusion.
Effect of checkpoint inhibition
Effect of ICI by calculating patients' overall median survival time.
Measured: ICI will be given for a maximum of 24 months, and follow-up is a maximum of one year post ICI, therefore is anticipated to be compleated within 4 years after start of inclusion.
Potential biomarkers for patient outcome including cDNA, mRNA and coagulation markers.
Investigations of blood samples stored in a biobank. These include cDNA, mRNA, acute phase reactants, markers of coagulation.
Measured: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion
Effect of checkpoint inhibition
Effect of ICI by calculating patients' median progression free survival time.
Measured: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion.
Best response of checkpoint inhibition
Best response during ICI in patients, defined as radiologic response rates using CT evaluations (Recist 1.1 criteria) combined with clinical status during ICI.
Measured: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion.
Secondary outcomes (3)
Registration of venous thromboembolism (VTE) during treatment with ICI.
Registration of VTE during treatment with ICI using expanded CT scans at baseline/6 months.
Measured: ICI will be given for a maximum of 24 months, which is anticipated to be within 4 years after start inclusion
The Quality of Life in patients at baseline and at follow-up using EORTC QoL-30.
Questionnaires of EORTC-Quality of Life-30 (EORTC QoL-30).
Measured: ICI will be given for a maximum of 24 months, and the follow-up period is one year, therefore completion is anticipated to be within 4 years after start inclusion.
The Quality of Life in patients at baseline and at follow-up using European EQ-5D-5L).
Evaluating Quality of Life using the European Quality of life - 5 Dimensions - 5 Levels questionnarie (Euro EQ-5D-5L) at baseline, during treatment and at follow-up.
Measured: ICI will be given for a maximum of 24 months, and the follow-up period is one year, therefore completion is anticipated to be within 4 years after start inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2018
- Primary completion8 Nov 2022
- Study completion1 Apr 2028 (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 CancerStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, University of Copenhagen, Odense Patient Data Explorative Network, Region of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Birgitte Bjørnhart, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870464
- Sponsor's protocol ID
- BBjornhart
- Status last verified
- May 2024
- First submitted
- 1 Mar 2019
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Age and Comorbidity on Effect of Treatment, Adverse Effects and Quality of Life in Danish Lung Cancer Patients Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT03870464
- Acronym / sponsor ID
- BBjornhart
- Keywords
- non-small cell lung cancer, immunotherapy, checkpoint inhibition, biomarkers, quality of life, real life patients
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, University of Copenhagen, Odense Patient Data Explorative Network, Region of Southern Denmark
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 Mar 2019 (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 LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition.
Detailed description
The era of immune checkpoint inhibition (ICI) has changed the treatment regimen for incurable non-small cell lung cancer. With that the hope of a more long-term survival has been introduced. ICI is given as standard therapy for selected NSCLC patients with incurable advanced or metastatic (stage IV) disease. For this group of patients clinical trial reports present a 3 year overall survival rate of around 30%. Checkpoint inhibition is also known as programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors and the PD-L1 tumor proportion score is currently the only clinically applicable biomarker used for this patient selection. New prognostic and predictive biomarkers are therefore warranted.The real life unselected NSCLC patient eligible for treatment with immunotherapy (check point inhibition) may be both older, with more comorbidity, more widespread disease and in poorer performance status than patients treated in clinical phase III trials. In this prospective single center study, clinical patient data, peripheral blood and baseline pre-treatment tumor biopsies are collected from NSCLC patients treated in any given treatment line with nivolumab, pembrolizumab or atezolizumab. Besides baseline samples consecutive blood samples will be collected for cytokine profiling and measurement of circulating tumor DNA (ctDNA) and micro RNA analysis. Baseline MRI of the brain screening for brain metastases and an extended CT-scan of thorax, abdomen and the lower extremities will be performed screening for venous thromboembolism (VTE). This along with comorbidity screening tools and quality of life assessments will provide detailed mapping of both patient and disease characteristics of potentially more frail patients including those with untreated brain metastases. By also registering immune related adverse events (irAE) prospectively in this study and doing additional blood samples in case of grade 3-4 toxicity, identification of biomarkers as predictors for effect and toxicity is durable. Hopefully this will contribute to more optimized treatment courses for those NSCLC patients to come.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective arm | – | Diagnostic Test: CT-scans extended, Diagnostic Test: MRI scan of the brain, Other: Prospective registration of irAEs, Behavioral: Quality of Life questionnairesQuality of Life questionnaires EORTC-QoL30 and Euro EQ-5D-5L questionnaires are distributed. Blood samples are collected consecutively during ICI and at a follow-up period of one year. CT-scans extended of thorax, abdomen and the lower extremities are performed at baseline and at 6 months. MRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease.Prospective registration of irAEs are registered during ICI and for one year of follow-up.Enrolment period 1th of April 2018- 31th of April 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 patients with incurable advanced (stage III A-C) or metastatic (stage IV) non-small cell lung cancer eligible for treatment with ICI at a Danish Hospital (Odense, Denmark). All possible treatment lines are allowed. ICI administered as nivolumab, pembrolizumab or atezolisumab.
Key inclusion criteria (7 listed)
- Age > 18 years
- Stage IV NSCLC or recurrent NSCLC.
- Squamous or non-squamous histology
- Any treatment-line - Independent of prior treatment
- Candidate for checkpoint inhibitor (PD-1/PD-L1 targeting agents) immunotherapy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| CT-scans extendedCT scans of thorax, abdomen and lower extremities are performed - screening for venous trombolisms at baseline and at 6 months in each patient. If VTE is diagnosed, medications according to guidelines will be administered. | Diagnostic test | Prospective arm |
| MRI scan of the brainMRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease. | Diagnostic test | Prospective arm |
| Prospective registration of irAEsirAEs are registered according to Common Terminology Criteria for Adverse Events version 4.0 by a medical doctor or trained experienced clinical nurse. | Other | Prospective arm |
| Quality of Life questionnairesParticipants fill out two Quality of Life questionnaires. The European Organization of Research and Treatment of Cancer, Quality of Life -30 questionnaire (EORTC QoL-30) and the European Questionnaire - 5 dimensions-5-level questionnaire (Euro EQ-5D-5L). | Behavioural | Prospective arm |
Primary outcome
Number of patients with CTCAE 4.0 toxicity registered Immune related autoimmune events (irAE).
Time frame: ICI will be given for a maximum of 24 months, and irAE registered up till one year post ICI treatment, which is anticipated to be within 4 years after of start inclusion.
Number of patients with CTCAE 4.0 toxicity registered according to age, comorbidity and predictive biomarkers.
Effect of checkpoint inhibition
Time frame: ICI will be given for a maximum of 24 months, and follow-up is a maximum of one year post ICI, therefore is anticipated to be compleated within 4 years after start of inclusion.
Effect of ICI by calculating patients' overall median survival time.
Potential biomarkers for patient outcome including cDNA, mRNA and coagulation markers.
Time frame: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion
Investigations of blood samples stored in a biobank. These include cDNA, mRNA, acute phase reactants, markers of coagulation.
Effect of checkpoint inhibition
Time frame: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion.
Effect of ICI by calculating patients' median progression free survival time.
Best response of checkpoint inhibition
Time frame: ICI will be given for a maximum of 24 months, and during follow-ip of one year post ICI treatment. Therefore it is anticipated to be compleated within 4 years after start inclusion.
Best response during ICI in patients, defined as radiologic response rates using CT evaluations (Recist 1.1 criteria) combined with clinical status during ICI.
3 secondary outcomes
Registration of venous thromboembolism (VTE) during treatment with ICI.
Time frame: ICI will be given for a maximum of 24 months, which is anticipated to be within 4 years after start inclusion
The Quality of Life in patients at baseline and at follow-up using EORTC QoL-30.
Time frame: ICI will be given for a maximum of 24 months, and the follow-up period is one year, therefore completion is anticipated to be within 4 years after start inclusion.
The Quality of Life in patients at baseline and at follow-up using European EQ-5D-5L).
Time frame: ICI will be given for a maximum of 24 months, and the follow-up period is one year, therefore completion is anticipated to be within 4 years after start inclusion.
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 7 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Birgitte Bjørnhart, MD principal investigator
University of Southern Denmark
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 Non-small Cell Lung Cancer and Quality of Life, run by University of Southern Denmark at 1 site in Denmark.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2024. 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 Denmark. 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?
Number of patients with CTCAE 4.0 toxicity registered Immune related autoimmune events (irAE). (time frame: ICI will be given for a maximum of 24 months, and irAE registered up till one year post ICI treatment, which is anticipated to be within 4 years after of start inclusion.). The study lists 5 primary outcomes in all. 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 7 May 2024.