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Eligibility criteria in phase 3 randomized controlled trials in metastatic non-small cell lung cancer
Jan Borysowski1, Danuta Kłosowska1, Marek Harhala2
1Department of Clinical Immunology, Medical University of Warsaw, Warsaw, Poland.
Background:
The purpose of this study was to assess the eligibility criteria in randomized controlled trials (RCTs) in metastatic non-small cell lung cancer (NSCLC).
Methods:
Eligible trials were phase 3 RCTs of systemic treatments for metastatic NSCLC, registered with the World Health Organization International Clinical Trials Registry Platform and started between 2009 and 2023. The odds of selected eligibility criteria were determined with multivariable logistic regression. Trends in the use of the eligibility criteria over time were assessed with the Fisher's exact test.
Results:
A total of 274 of 386 trials (71%) excluded patients with an Eastern Cooperative Oncology Group (ECOG) score of >1; the odds of excluding these patients were higher in RCTs of chemotherapy (adjusted odds ratio [aOR], 3.46; 95% CI [confidence interval], 1.91-6.50; p < .001) and immunotherapy (aOR, 3.31; 95% CI, 1.58-7.21; p = .001) and in recent trials (aOR, 1.83; 95% CI, 1.09-3.10; p = .02). A total of 95 of 386 trials (24.6%) had an upper age limit of 85 years or younger; this was more likely in trials performed in Asia (aOR, 8.83; 95% CI, 3.27-28.24; p < .001). The proportion of trials with eligibility criteria concerning comorbidities did not significantly decrease over time (p > .05). None of the trials had any eligibility criteria concerning frailty.
Conclusions:
The eligibility criteria in phase 3 RCTs in metastatic NSCLC continue to be strict. In some trials, judicious modifications of these criteria should be considered to improve the enrollment of clinically relevant populations of patients, especially older adults, individuals with an ECOG score of 2, and those with selected comorbidities.
Insights
Strict eligibility criteria in metastatic non-small cell lung cancer (NSCLC) trials exclude many patients. Modifications are needed to enroll more older adults and those with ECOG scores of 2 or comorbidities.
Area of Science:
- Oncology
- Clinical Trials
- Biostatistics
Background:
- Randomized controlled trials (RCTs) are crucial for advancing cancer treatment.
- Eligibility criteria in clinical trials can significantly impact patient enrollment and generalizability of results.
- Metastatic non-small cell lung cancer (NSCLC) is a significant public health concern, necessitating efficient clinical trial designs.
Purpose of the Study:
- To assess the current eligibility criteria used in phase 3 randomized controlled trials (RCTs) for metastatic non-small cell lung cancer (NSCLC).
- To identify trends and potential biases in patient selection for these critical trials.
- To evaluate the impact of specific criteria on the inclusion of diverse patient populations.
Main Methods:
- Systematic review of phase 3 RCTs for metastatic NSCLC registered on the WHO ICTRP (2009-2023).
- Multivariable logistic regression analysis to determine the odds of specific eligibility criteria.
- Fisher's exact test to assess temporal trends in the application of these criteria.
Main Results:
- 71% of trials excluded patients with an ECOG score >1, with higher odds in chemotherapy and immunotherapy trials.
- Recent trials showed increased odds of excluding patients with ECOG score >1.
- 24.6% of trials had an upper age limit of ≤85 years, more prevalent in trials conducted in Asia.
- No significant decrease in criteria related to comorbidities was observed over time.
- No trials included criteria assessing patient frailty.
Conclusions:
- Phase 3 RCTs for metastatic NSCLC maintain stringent eligibility criteria, potentially limiting patient accrual.
- Consideration should be given to modifying criteria to include older adults, patients with ECOG score of 2, and those with specific comorbidities.
- Adjusting eligibility criteria can enhance the enrollment of more representative patient populations, improving the clinical relevance of trial findings.
