Table 4.
Principal single-arm Phase I–II trials on NTRK inhibitors in NTRK-fused advanced NSCLC patients.
| Drug | Trial | Phase | Therapy Line * | N pts | Main Results | Status *** |
|---|---|---|---|---|---|---|
| Entrectinib | ALKA-372-001 (EudraCT2012–000148–88) |
I | Any | 10 ** | ORR = 70% mDOR = 12.9 mo mPFS = 14.9 mo mOS = 23.9 mo |
Closed |
| STARTRK-1 (NCT02097810) |
I | Any | Closed | |||
| STARTRK-2 (NCT02568267) |
II | Any | Ongoing | |||
| Larotrectinib | LOXO-TRK-14001 (NCT02122913) |
I | Any | 12 ** | ORR = 75% mDOR = NE mPFS = 28.3 mo mOS = 44.4 mo |
Closed |
| LOXO-TRK-15003 (NCT02637687) |
I/II | Any | Ongoing | |||
| NAVIGATE (NCT02576431) |
II | Any | Ongoing |
N—number; pts patients; ORR—overall response rate; mo—month; mDOR—median duration of response; mPFS—median progression-free survival; mOS—median overall survival; NE—not estimable. An asterisk (*) indicates the line or lines of treatment for advanced NSCLC in which the investigational agent or regimen was employed in each reported trial. Two asterisks (**) indicate that the studies were pooled analyses. Three asterisks (***) indicate that Entrectinib and Larotrectinib FDA approved for NTRK-fused solid tumors.