Researchers Look at Clinical Trial Eligibility Criteria for Those With Metastatic NSCLC

By: Victoria Kuhr, MS
Posted: Friday, January 31, 2025

Alissa S. Marr, MD, of the University of Nebraska Medical Center, Omaha, and colleagues observed that the data from their retrospective chart review support less restrictive clinical trial eligibility criteria for patients with metastatic non–small cell lung cancer (NSCLC) who were treated with targeted therapy and immunotherapy regimens. These findings were published in the journal Oncology.

This review included patients with metastatic NSCLC who received first-line systemic therapy at a single academic institution. Each patient’s chart was reviewed for qualifying eligibility for the phase III clinical trial. The primary endpoint was to determine the difference in survival time between those who would have been eligible and those who would have been ineligible for the clinical trial of the treatment regimen.

The review included 170 patients who received first-line systemic therapy. Of them, 109 received combined chemotherapy, 25 received immunotherapy, and 36 received targeted therapy. There were 94 women and 76 men in the study, with a median age of 69.6 years. A majority (n = 131) had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. The researchers observed a statistically significant difference in the restricted mean survival time between the eligible and ineligible groups in those who received combined chemotherapy (P = .03), in contrast to either the immunotherapy group (P = .06) or the targeted therapy group (P  = 0.14).

Of the 163 patients’ eligible data, 105 patients (64.4%) were eligible, and 58 patients (35.6%) were ineligible for the clinical trial. Of the 58 ineligible patients, 38 (65.5%) had one ineligibility criterion, and 20 patients did not fulfill two or more criteria for their given clinical trial. A higher ECOG performance status and prior malignancy were the causes of approximately 40% of all ineligibility criteria; patients with a lower ECOG performance status were significantly more likely to be eligible (P < .0001). There was a significant difference in the frequency of eligibility between treatment groups (P = .008).

Disclosure: For full disclosures of the study authors, visit cancernetwork.com.

Oncology

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