Comprehensive Geriatric Assessment in Elderly Non-Small Cell Lung Cancer Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Lung Cancer; Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Questionnaires about symptoms

• Study Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • Hull
    • Cottingham, Hull, United Kingdom, HU16 5JQ
      • Castle Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients ≥70 years old receiving ICI treatment at the Queen's Centre for Oncology and Haematology, Hull.

Description

Inclusion Criteria:

1. Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
2. Patients able to give informed consent.

Exclusion Criteria:

1. Patients already on treatment with ICIs.
2. Patients with CNS or leptomeningeal spread / disease progression.
3. ECOG performance status III/IV.
4. Patients with severe autoimmune diseases.
5. Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of irAEs at 3 months.	At 3 months after entering the study.
Nature of irAEs at 3 months.	At 3 months after entering the study.
Grading of irAEs at 3 months.	At 3 months after entering the study.
Incidence of irAEs at 6 months.	At 6 months after entering the study.
Nature of irAEs at 6 months.	At 6 months after entering the study.
Grading of irAEs at 6 months.	At 6 months after entering the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of re-admission into hospital at 3 months.	At 3 months after entering the study.
Incidence of re-admission into hospital at 6 months.	At 6 months after entering the study.
Duration of inpatient stay (conditional on re-admission into hospital).	Up to 12 months after entering the study.
Death within 30 days (if applicable).	Within 30 days of entering the study.

Collaborators and Investigators

• Sponsor: University of Hull
• Collaborators: Hull University Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): November 1, 2022
• Study Completion (Estimated): November 1, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: V1.1 10.09.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No