{"entity":{"id":"idea-tr1-ecog-2-dedicated-cohorts","kind":"idea","name":"Dedicated cohorts for patients with performance status 2 in first-line trials","aka":[],"tldr":"Trials usually take only patients who are up and about most of the day. Those who spend more time resting, a common group in real clinics, are excluded, so nobody knows how to treat them. A dedicated group in each trial would answer that.","summary":"First-line trials of new regimens include a pre-specified ECOG performance status 2 cohort, randomised where feasible, with safety-led dose modification, primary endpoints appropriate to the population (OS, time on treatment, QoL) and reporting in the label. Some lung cancer trials have run dedicated PS2 studies; the proposal generalises this.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"}],"tags":[],"related":[],"cancers":["nsclc","pancreatic","gastric","esophageal"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity","b-aging-comorbidity"],"keyPapers":["paper-loree-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"PS2 cohorts will show that benefit is preserved for some regimens and absent or harmful for others, information that changes real-world prescribing for a population that currently receives extrapolated care.","rationale":"PS2 patients are a sizeable share of real-world first-line recipients, especially in lung, pancreatic and upper gastrointestinal cancers, and receive full-dose regimens tested only in fitter patients.","test":"Require PS2 cohorts in first-line registrational trials for three cancers with high PS2 prevalence and track the resulting label statements and real-world outcomes.","maturity":"early-clinical","actor":"industry","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr1-ecog-2-dedicated-cohorts/","neighbours":{"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}],"paper":[{"id":"paper-loree-jama-oncol","kind":"paper","name":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","route":"/key-papers/paper-loree-jama-oncol/"}]}}