Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05118789 | A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1) | PHASE1 | RECRUITING | 359 | — | — | Jan 4, 2022 | Dec 31, 2028 | Oct 24, 2025 | 63 | United States, Australia +12 |
Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%
To determine the RP2D
To determine ORR as assessed by BICR
| Arm | Type | Description |
|---|---|---|
| Phase 1 dose escalation | EXPERIMENTAL | Zidesamtinib (NVL-520) oral daily dosing |
| Cohort 2a | EXPERIMENTAL | ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy |
| Cohort 2b | EXPERIMENTAL | ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy |
| Cohort 2c | EXPERIMENTAL | ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy |
| Cohort 2d | EXPERIMENTAL | ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy |
| Cohort 2e | EXPERIMENTAL | ROS1+ solid tumor and progressed on any prior therapy |
| Name | Type | Description |
|---|---|---|
| Zidesamtinib (NVL-520) | DRUG | Oral tablet of zidesamtinib (NVL-520) |
Inclusion Criteria: 1. Age ≥18 years (Cohort 2e only: Age ≥12 years). 2. Disease Criteria: 1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement. 2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytological...