LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

University of Southern Denmark (SDU)

Status: Active, not recruiting

Conditions: Venous Thromboembolism; Brain Metastases; Quality of Life; Non-small Cell Lung Cancer

Treatments: Other: Prospective registration of irAEs; Diagnostic Test: MRI scan of the brain; Diagnostic Test: CT-scans extended; Behavioral: Quality of Life questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT03870464

BBjornhart

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Prospective arm

Description:

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.

Treatment:

Behavioral: Quality of Life questionnaires

Other: Prospective registration of irAEs

Diagnostic Test: MRI scan of the brain

Diagnostic Test: CT-scans extended