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Clinical Trials/NCT05230888
NCT05230888
Withdrawn
Not Applicable

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

University of Hull1 site in 1 countryFebruary 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
University of Hull
Locations
1
Primary Endpoint
Nature of irAEs at 3 months.
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 9, 2022
End Date
November 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Nature 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.

Incidence 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.

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.

Secondary Outcomes

  • Death within 30 days (if applicable).(Within 30 days of entering the study.)
  • 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.)

Study Sites (1)

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