Non-small Cell Lung CancerQuality of LifeBrain MetastasesVenous Thromboembolism
Investigational drug(s) / intervention(s)
CT-scans extendedMRI scan of the brainProspective registration of irAEsQuality of Life questionnaires
CT-scans extended: 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 brain: 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: 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 questionnaires: 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* none
Primary outcome measure(s)
Number of patients with CTCAE 4.0 toxicity registered Immune related autoimmune events (irAE). — 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 — 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. — 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 — 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 — 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.
Trial sites (1)
Facility
City
Region
Status
Department of Oncology, Odense University Hospital
Odense
Denmark
More University of Southern Denmark trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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