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

Lung Cancer Clinical Trial

Official title:

A Prospective Study of Comprehensive Geriatric Assessment (CGA) in Non-Small Cell Lung Cancer Patients (NSCLC) Undergoing Treatment With Immune Checkpoint Inhibitors.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05230888
• Other study ID #: V1.1 10.09.2021
• Status: Withdrawn
• Start date: February 9, 2022
• Est. completion date: November 2022

Study information

• Verified date: August 2023
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Castle Hill Hospital	Cottingham	Hull

Sponsors (2)

Lead Sponsor	Collaborator
University of Hull	Hull University Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of irAEs at 3 months.		At 3 months after entering the study.
Primary	Nature of irAEs at 3 months.		At 3 months after entering the study.
Primary	Grading of irAEs at 3 months.		At 3 months after entering the study.
Primary	Incidence of irAEs at 6 months.		At 6 months after entering the study.
Primary	Nature of irAEs at 6 months.		At 6 months after entering the study.
Primary	Grading of irAEs at 6 months.		At 6 months after entering the study.
Secondary	Incidence of re-admission into hospital at 3 months.		At 3 months after entering the study.
Secondary	Incidence of re-admission into hospital at 6 months.		At 6 months after entering the study.
Secondary	Duration of inpatient stay (conditional on re-admission into hospital).		Up to 12 months after entering the study.
Secondary	Death within 30 days (if applicable).		Within 30 days of entering the study.