Table 2.
Ongoing clinical trials of novel ALK TKIs against ALK-arranged NSCLC.
| Clinical trial identifier | Study design | Intervention | Setting | Primary endpoint | Phase | Status |
|---|---|---|---|---|---|---|
| NCT04009317 | 260 participants Parallel assignment Randomized, open label |
TQ-B3139 vs. crizotinib | First line | PFS | 3 | Recruiting |
| NCT04632758 | 330 participants Parallel assignment Randomized, open label |
WX-0593 vs. crizotinib | First line | PFS | 3 | Recruiting |
| NCT04056572 | 135 participants Single-group assignment Non-randomized, open label |
TQ-B3139 | Second line | ORR | 2 | Recruiting |
| NCT04641754 | 176 participants Single-group assignment Non-randomized, open label |
WX-0593 | Second line | ORR | 2 | Recruiting |
| NCT04211922 | 104 participants Single-group assignment Non-randomized, open label |
Alkotinib | Second line | ORR | 2 | Recruiting |
| NCT02568267 | 60 participants (basket) Single-group assignment Non-randomized, open label |
Entrectinib (RXDX-101) | Second line | ORR | 2 | Recruiting |
| NCT03093116 | 500 participants (basket) Single-group assignment Non-randomized, open label |
Repotrectinib (TPX-0005) | Second line | DLT, RP2D, ORR | 1/2 | Recruiting |
| NCT04849273 | 210 participants Single-group assignment Non-randomized, open label |
TPX-0131 | Second line | DLT, RP2D, ORR | 1/2 | Recruiting |
| NCT04237805 | 280 participants Single-group assignment Non-randomized, open label |
SAF-189s (foritinib) | First/second line | DLT, ORR | 1/2 | Recruiting |
| NCT03130881 | 60 participants Single-group assignment Non-randomized, open label |
PLB1003 | Second line | DLT | 1 | Recruiting |
| NCT03607188 | 18 participants Single-group assignment Non-randomized, open label |
Alkotinib | Second line | DLT | 1 | Recruiting |
| NCT05055232 | 120 participants Single-group assignment Non-randomized, open label |
XZP-3621 | Second line | Toxicity, DLT, MTD | 1 | Recruiting |
| NCT02695550 | 40 participants Single-group assignment Non-randomized, open label |
CT-707 | Second line | DLT, toxicity | 1 | Unknown |
PFS, progression-free survival; ORR, objective response rate; DLT, dose-limiting toxicity; RP2D, recommended phase 2 dose; MTD, maximum tolerated dose.