Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Neladalkib · 2 trials · 4 indications
Time from randomization to BICR-assessed radiographic disease progression or death
Define the dose limiting toxicities (DLTs)
To determine the RP2D
To determine ORR as assessed by BICR
Incidence and severity of treatment-emergent adverse events (TEAEs)
To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of repaglinide
To determine the effect of multiple oral doses of neladalkib (NVL-655) on the PK of a single oral dose of midazolam
To determine the effect of itraconazole on the single oral dose PK of neladalkib (NVL-655)
| Arm | Type | Description |
|---|---|---|
| Neladalkib (NVL-655) | EXPERIMENTAL | 150mg taken orally once daily (QD) |
| Alectinib | ACTIVE_COMPARATOR | 600mg taken orally twice daily (BID) |
| Phase 1 dose escalation | EXPERIMENTAL | Neladalkib (NVL-655) oral daily dosing |
| Cohort 2a | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. |
| Cohort 2b | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. |
| Cohort 2c | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed. |
| Cohort 2d | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed. |
| Cohort 2e | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts. |
| Cohort 2f | EXPERIMENTAL | Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists. |
| Cohort G (DDI sub-study) | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI |
| Cohort H (DDI sub-study) | EXPERIMENTAL | Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received ≥1 prior ALK TKI |
| Name | Type | Description |
|---|---|---|
| Neladalkib (NVL-655) | DRUG | Oral tablet of Neladalkib (NVL-655) |
| Alectinib | DRUG | Oral capsule of alectinib |
| Midazolam | DRUG | Oral Solution of Midazolam |
| Repaglinide | DRUG | Oral Tablet of Repaglinide |
| Itraconazole | DRUG | Oral Solution of Itraconazole |
Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 3. No prior systemic anticancer t...
Top 20 of 86 competitors