Clinical trial · Observational
LIFE - Lung Cancer, Immunotherapy, Frailty, Effect
The Impact of Age and Comorbidity on Effect of Treatment, Adverse Effects and Quality of Life in Danish Lung Cancer Patients Receiving Immunotherapy
NCT03870464CI-TRIAL-00076832active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-scans extended | Diagnostic Test | — | UNRESOLVED |
| MRI scan of the brain | Diagnostic Test | — | UNRESOLVED |
| Prospective registration of irAEs | Other | — | UNRESOLVED |
| Quality of Life questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Diagnostic Test: CT-scans extended
- Diagnostic Test: MRI scan of the brain
- Other: Prospective registration of irAEs
- Behavioral: Quality of Life questionnaires
Primary outcomes (5)
- measure
- Number of patients with CTCAE 4.0 toxicity registered Immune related autoimmune events (irAE).
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.