Safety results
nausea, DLTs, dyspnea, neutropenia, fatigue, diarrhea, TEAEs, SAEs, cough, empyema, deaths
DISEASE PROGRESSION, NEUTROPENIA, EMPYEMA, EVENTS, RECTAL HEMORRHAGE
In the nintedanib 150 mg BID group, the median duration of exposure was 1.8 months (range: 0.3–5.5) for nintedanib and 1.4 months (range: 0.3–3.7) for docetaxel. In the nintedanib 200 mg BID group, the median exposure was 1.3 months (range: 0.2–9.9) for nintedanib and 1.2 months (range: 0.3–8.1) for docetaxel.All patients in the nintedanib 150 mg BID group and 6/7 patients (85.7%) in the 200 mg BID group reported TEAEs (In addition to the dose reductions due to DLTs described above, the nintedanib dose was reduced for one patient receiving nintedanib 200 mg BID (to 150 mg) for grade 2 diarrhea, which started on Day 3 and was unresolved at the end of the study despite treatment. The same patient had a grade 2 rectal hemorrhage lasting 2 days that resolved without requiring an intervention. AEs required permanent discontinuation of either one or both trial drugs in one patient receiving nintedanib 150 mg BID and two patients receiving nintedanib 200 mg BID. In the nintedanib 150 mg BID group, discontinuation of both docetaxel and nintedanib was required in a patient experiencing grade 3 fatigue, which started on Day 8 and was unresolved at the end of treatment. This was considered non-serious and not related to the trial medication. In the nintedanib 200 mg BID group, docetaxel was discontinued in two patients. One patient experienced grade 3 fatigue, which started on day 40 and had not resolved by the final visit. The other patient experienced grade 1 neutropenia, which started on day 73 and lasted for 30 days before resolving. Both events were considered treatment-related but non-serious.SAEs were reported in three patients (42.9%) in the nintedanib 150 mg BID group, and two patients (28.6%) in the nintedanib 200 mg BID group, all of which required hospitalization. SAEs in the nintedanib 150 mg BID group were grade 3 nausea, dyspnea, and cough (cough was concomitant with dyspnea in one patient). SAEs in the nintedanib 200 mg BID group were grade 3 general physical health deterioration, and grade 2 empyema. None were considered treatment related. Two deaths occurred, which included a 60-year-old male in the nintedanib 150 mg BID group and a 66-year-old male in the nintedanib 200 mg BID group. Both deaths were related to disease progression, and neither was considered to be treatment related.