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Published on: September 8, 2023
The eligibility of advanced non-small-cell lung cancer patients for targeted therapy clinical trials
J Clarey1, S C Kao2, S J Clarke3
1Faculty of Medicine, University of Sydney, Sydney.
Background:
The selection criteria for phase III trials are often stringent. We aimed to determine how many advanced non-small-cell lung cancer (NSCLC) patients would have been eligible for phase III targeted therapy trials and the proportion receiving anticancer treatment.
Patients And Methods:
From March 2007 to May 2008, all advanced NSCLC patients presented at our lung cancer multidisciplinary team meeting were included to assess eligibility for the targeted therapy trials: ECOG-4599, AVAiL, FLEX, TALENT, INTACT-1, INTACT-2, ESCAPE, NEXUS and MONET1. Medical records were examined to determine treatment utilisation and overall survival.
Results:
A total of 62 patients were registered: 63% male; median age 71 years; 61% stage IIIB disease. Percentages that met criteria were: ECOG-4599 31%, AVAiL 24%, FLEX 69%, TALENT 27%, INTACT-1 50%, INTACT-2 42%, ESCAPE 39%, NEXUS 63% and MONET1 34%. Common reasons for ineligibility were insufficient life expectancy, poor performance status, abnormal bloods, proteinuria and associated cancer problems. Systemic therapies were received by 66% of patients and median survival was 10.3 months.
Conclusion:
Only 24%-69% were eligible for targeted therapy trials but 66% received anticancer treatment. Clinical trials in patients with advanced NSCLC need to be more representative of the majority of patients.
Insights
Many advanced non-small-cell lung cancer patients are ineligible for phase III targeted therapy trials. Most patients received some form of anticancer treatment, highlighting a need for more representative clinical trials.
Area of Science:
- Oncology
- Clinical Trials
- Lung Cancer Research
Background:
- Phase III clinical trials often have stringent eligibility criteria.
- Assessing the impact of these criteria on patient populations is crucial for trial design.
Purpose of the Study:
- To evaluate the eligibility of advanced non-small-cell lung cancer (NSCLC) patients for phase III targeted therapy trials.
- To determine the proportion of these patients who received anticancer treatment.
Main Methods:
- A cohort of advanced NSCLC patients was assessed for eligibility across nine targeted therapy trials.
- Medical records were reviewed to determine treatment utilization and survival outcomes.
Main Results:
- Eligibility varied significantly across trials, ranging from 24% to 69%.
- Common reasons for ineligibility included poor performance status and comorbidities.
- 66% of patients received systemic therapies, with a median survival of 10.3 months.
Conclusions:
- A substantial proportion of advanced NSCLC patients do not meet eligibility criteria for current phase III targeted therapy trials.
- Clinical trial designs should aim for greater inclusivity to better reflect the broader patient population.
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