An observational study in Lung Cancer and Non-small Cell Lung Cancer, sponsored by University of Hull. Withdrawn at 1 site in United Kingdom. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by University of Hull · Observational
Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients > 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience.
Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients > 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup.
Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients > 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
Browse Lung Neoplasms studies →University of Hull is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
NSCLC patients ≥70 years old receiving ICI treatment at the Queen's Centre for Oncology and Haematology, Hull.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The effect of immunotherapy treatment will be assessed using the comprehensive geriatric assessment (CGA) and vulnerable elders survey (VES-13) in 100 non-small cell lung cancer patients, aged ≥70 years old, receiving immune checkpoint inhibitor (ICI) treatment.
Other: Questionnaires about symptoms
The CGA and VES-13 questionnaires will be conducted at baseline. Immune-related adverse events (irAEs) will be investigated at 3 and 6 months using a Patient Knows Best symptom tracker form (local Trust created).
Incidence of irAEs at 3 months.
Time frame: At 3 months after entering the study.
Nature of irAEs at 3 months.
Time frame: At 3 months after entering the study.
Grading of irAEs at 3 months.
Time frame: At 3 months after entering the study.
Incidence of irAEs at 6 months.
Time frame: At 6 months after entering the study.
Nature of irAEs at 6 months.
Time frame: At 6 months after entering the study.
Grading of irAEs at 6 months.
Time frame: At 6 months after entering the study.
Incidence of re-admission into hospital at 3 months.
Time frame: At 3 months after entering the study.
Incidence of re-admission into hospital at 6 months.
Time frame: At 6 months after entering the study.
Duration of inpatient stay (conditional on re-admission into hospital).
Time frame: Up to 12 months after entering the study.
Death within 30 days (if applicable).
Time frame: Within 30 days of entering the study.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Nov 2022, 9 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Hull