Clinical Trial Eligibility and Outcomes in Patients With Metastatic NSCLC Treated Outside of Clinical Trials
These data support less restrictive clinical trial eligibility criteria for patients with metastatic NSCLC.
A retrospective chart review of 170 patients with metastatic NSCLC who received first‑line systemic therapy was performed to evaluate whether patients would have met phase‑III trial eligibility criteria used for the specific regimens they received. Eligibility status was compared with restricted‑mean survival time. Overall, eligible patients had a longer survival (31.5 vs. 20.9 months, P=0.03). In the combined‑chemotherapy cohort, eligible patients survived significantly longer than ineligible patients (19.9 vs. 13.2 months, P=0.03), whereas differences were not significant in the immunotherapy or targeted‑therapy groups. Most ineligible patients were excluded for a single criterion, suggesting that modest loosening of eligibility would increase enrolment.
Reducing restrictive eligibility criteria can broaden trial generalizability, improve accrual, and provide real‑world evidence that patients who would otherwise be excluded can safely and effectively receive approved therapies.
Bizonyítékszint: Korai humán adat. Kis vagy feltáró emberi adat.
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