Lung Cancer Clinical Trials in Latin America in the Era of Cooperative Groups: A 20-Year Analysis.

Abstract

The aim of this study is to characterize lung cancer treatment clinical trials in Latin America before (January 2001-December 2011) and after (January 2012-December 2021) the organization of major Latin American oncology cooperative groups. Interventional clinical trials were identified in ClinicalTrials.gov using the search terms "lung cancer," country filters for 20 Latin American countries, and study start dates January 1, 2001-December 31, 2011, and January 1, 2012-December 31, 2021. Clinical trials were categorized as either originating in Latin America (LA) or outside Latin America (non-LA) with participation of Latin American countries. Descriptive statistics, two-sided Z-scores, and chi-square analyses with 95% CIs were calculated. Overall, 273 clinical trials involving Latin American countries between 2001 and 2021 were identified. Comparing 2001-2011 with 2012-2021, there was an increase in total clinical trials (100 <i>v</i> 173; <i>P</i> < .001). Only 9% (26 of 273) of all trials were LA trials. There was a marked decrease in the proportion of LA trials (14% <i>v</i> 7%, <i>P</i> = .058) and estimated enrollment to LA trials (3,245 <i>v</i> 1,190 patients; <i>P</i> < .001). Recruiting of patients with <i>EGFR</i> (29% <i>v</i> 7%; <i>P</i> < .01) and <i>KRAS</i> (18% <i>v</i> 2%; <i>P</i> < .01) driver mutations also decreased. Trial participation was highest in Brazil, Mexico, Argentina, Chile, and Peru and increased over time: Brazil (61 <i>v</i> 108; 77% increase), Mexico (40 <i>v</i> 88; 120% increase), Argentina (50 <i>v</i> 78; 56% increase), Chile (25 <i>v</i> 57; 128% increase), and Peru (14 <i>v</i> 37; 164% increase). There was a significant increase in clinical trial participation by Latin American countries, from 2001-2011 to 2012-2021. However, there were few clinical trials which originated in Latin America or focused on patients with driver mutations.