Lung CancerNCT05230888
Comprehensive Geriatric Assessment in Elderly Non-Small Cell Lung Cancer Patients
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by University of Hull at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Questionnaires about symptoms
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2022to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: NSCLC patients ≥70 years old receiving ICI treatment at the Queen's Centre for Oncology and Haematology, Hull.
Who may be able to join
- Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
- Patients able to give informed consent.
Who cannot join
- Patients already on treatment with ICIs.
- Patients with CNS or leptomeningeal spread / disease progression.
- ECOG performance status III/IV.
- Patients with severe autoimmune diseases.
- Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Comprehensive Geriatric Assessment (CGA) in Non-Small Cell Lung Cancer Patients (NSCLC) Undergoing Treatment With Immune Checkpoint Inhibitors.
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.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- Questionnaires about symptoms
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires about symptomsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Cohort | 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. Receives: Other: Questionnaires about symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of irAEs at 3 months.
Measured: At 3 months after entering the study.
Nature of irAEs at 3 months.
Measured: At 3 months after entering the study.
Grading of irAEs at 3 months.
Measured: At 3 months after entering the study.
Incidence of irAEs at 6 months.
Measured: At 6 months after entering the study.
Nature of irAEs at 6 months.
Measured: At 6 months after entering the study.
Grading of irAEs at 6 months.
Measured: At 6 months after entering the study.
Secondary outcomes (4)
Incidence of re-admission into hospital at 3 months.
Measured: At 3 months after entering the study.
Incidence of re-admission into hospital at 6 months.
Measured: At 6 months after entering the study.
Duration of inpatient stay (conditional on re-admission into hospital).
Measured: Up to 12 months after entering the study.
Death within 30 days (if applicable).
Measured: Within 30 days of entering the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start9 Feb 2022
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Research personnel not recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230888
- Sponsor's protocol ID
- V1.1 10.09.2021
- Status last verified
- Aug 2023
- First submitted
- 12 Jan 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Comprehensive Geriatric Assessment (CGA) in Non-Small Cell Lung Cancer Patients (NSCLC) Undergoing Treatment With Immune Checkpoint Inhibitors.
- ClinicalTrials.gov ID
- NCT05230888
- Acronym / sponsor ID
- V1.1 10.09.2021
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Research personnel not recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: Questionnaires about symptomsThe 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- NSCLC patients ≥70 years old receiving ICI treatment at the Queen's Centre for Oncology and Haematology, Hull.
Key inclusion criteria (2 listed)
- Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
- Patients able to give informed consent.
Key exclusion criteria (5 listed)
- Patients already on treatment with ICIs.
- Patients with CNS or leptomeningeal spread / disease progression.
- ECOG performance status III/IV.
- Patients with severe autoimmune diseases.
- Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires about symptomsThe 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). | Other | Cohort |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by University of Hull at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of irAEs at 3 months. (time frame: At 3 months after entering the study.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.