LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

NCT03870464 | Active Not Recruiting

• 1 other identifier: BBjornhart
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

non-small cell lung cancer; immunotherapy; checkpoint inhibition; biomarkers; quality of life; real life patients

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

Study Arms (1)

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.

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

Interventions

CT-scans extended DIAGNOSTIC_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.

Prospective arm

MRI scan of the brain DIAGNOSTIC_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 arm

Prospective registration of irAEs OTHER

irAEs are registered according to Common Terminology Criteria for Adverse Events version 4.0 by a medical doctor or trained experienced clinical nurse.

Prospective arm

Quality of Life questionnaires BEHAVIORAL

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).

Prospective arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• University of Copenhagen: collaborator
• Odense Patient Data Explorative Network: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Department of Oncology, Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor-biopsies at baseline. Blood samples at baseline and consecutively

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Birgitte Bjørnhart, MD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 12, 2019
• Study Start: April 1, 2018
• Primary Completion: November 8, 2022
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

DK (1)