The Sponsor agreed to conduct a study with a sufficient representation of Black patients as it was identified that about 9% of patients with NSCLC with EGFR exon 20 insertion mutations were Black.12 Further guidance from the agency on what would constitute a sufficient population to ensure representation (depending on the prevalence of the disease in the US and in different minority populations) would be helpful. Here, EGFR is linked to non-small cell lung carcinoma.