- Any ongoing potentially reversible treatment-related toxicities must be (National Cancer Institute-Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03) <=Grade 1 and not progressing in severity, except alopecia or the expected EGFR-TKI toxicities of rash or diarrhea that are stable with intervention and then only if agreed to by the GlaxoSmithKline (GSK) Medical Monitor and the investigator.