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Updated: Nov 18, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non-Small Cell Lung Cancer: Real-World
R Donald Harvey1, Suanna S Bruinooge2, Li Chen3
1Winship Cancer Institute of Emory University, Druid Hills, Georgia.
Purpose:
Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number of patients eligible for trials, using recommendations of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.
Experimental Design:
A retrospective, observational analysis used electronic health record data from ASCO's CancerLinQ Discovery database. Study cohort included patients with advanced non-small cell lung cancer treated from 2011 to 2018. Patients were grouped by traditional criteria [no brain metastases, no other malignancies, and creatinine clearance (CrCl) ≥ 60 mL/minute] and broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute).
Results:
The analysis cohort included 10,500 patients. Median age was 68 years, and 73% of patients were White. Most patients had stage IV disease (65%). A total of 5,005 patients (48%) would be excluded from trial participation using the traditional criteria. The broadened criteria, however, would allow 98% of patients (10,346) to be potential participants. Examination of patients included by traditional criteria (5,495) versus those added (4,851) by broadened criteria showed that the number of women, patients aged 75+ years, and those with stage IV cancer was significantly greater using broadened criteria.
Conclusions:
This analysis of real-world data demonstrated that broadening three common eligibility criteria has the potential to double the eligible patient population and include trial participants who are more representative of those encountered in practice.See related commentary by Giantonio, p. 2369.
Insights
Broadening cancer clinical trial eligibility criteria can double patient eligibility and increase trial diversity. This approach helps enroll more representative patient populations in oncology research.
Area of Science:
- Oncology
- Clinical Trials
- Health Services Research
Background:
- Cancer clinical trials frequently face slow accrual and fail to meet enrollment targets.
- Restrictive eligibility criteria are a primary contributor to these enrollment challenges.
- Current criteria can limit patient participation and compromise the external validity of trial findings.
Purpose of the Study:
- To evaluate the impact of broadening specific eligibility criteria on the number and characteristics of eligible patients for cancer clinical trials.
- To assess the potential of revised criteria, based on recommendations from the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research, to improve trial inclusivity.
Main Methods:
- A retrospective observational analysis was conducted using electronic health record data from ASCO's CancerLinQ Discovery database.
- The study cohort comprised 10,500 patients with advanced non-small cell lung cancer treated between 2011 and 2018.
- Patients were assessed based on traditional criteria (no brain metastases, no other malignancies, creatinine clearance [CrCl] ≥ 60 mL/minute) versus broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute).
Main Results:
- Under traditional criteria, 48% of patients (5,005) were excluded from trial participation.
- Broadened criteria would increase eligibility to 98% of patients (10,346).
- The broadened criteria significantly increased the inclusion of women, patients aged 75 years and older, and those with stage IV cancer.
Conclusions:
- Broadening three common eligibility criteria can potentially double the eligible patient population for cancer clinical trials.
- This strategy enhances the likelihood of enrolling participants who more accurately reflect the real-world patient population encountered in clinical practice.
- The findings suggest a pathway to improve trial diversity and the generalizability of research outcomes.
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