Table 2 Dose-escalation level schema and details of dose-limiting toxicities
Treatment | Level 1 | Level 2 a | Level 3 |
|---|---|---|---|
Afatinib (once per day; mg) | 20 | 30 | 40 |
Osimertinib (once per day; mg) | 80 | 80 | 80 |
Number of DLT evaluable patients | n = 6 | n = 6 | n = 0 |
DLT, n (%) | 1 (16.7) | 2 (33.3) | 0 (0) |
Details of DLTs | 77 years, female: Grade 3 diarrhea | 75 years, female: persistent Grade 2 nausea/vomiting 76 years, female: Grade 3 diarrhea | – |
Additional toxicity profile after the observational periods | – | 50 years, female: persistent Grade 2 diarrhea 70 years, female: Grade 3 rash |