Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Neladalkib (NVL-655)
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...
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Neladalkib (NVL-655) is an investigational small molecule being developed for non-small cell lung cancer (NSCLC) and locally advanced solid tumors. It is studied in patients with ALK rearrangement or activating ALK mutation, including those with anaplastic lymphoma kinase-positive NSCLC.
Neladalkib targets ALK, a kinase enzyme. As a small molecule kinase inhibitor, it is designed to interfere with ALK-driven signaling in tumors that harbor ALK rearrangements or activating mutations.
Neladalkib is being developed by Nuvalent, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NUVL. The company is conducting clinical trials to evaluate the drug in patients with advanced solid tumors.
Neladalkib is in clinical development. It is being evaluated in a Phase 1 trial (NCT05384626) and a Phase 3 trial (NCT06765109), both currently recruiting. The drug has not been approved by the FDA and remains investigational.
Neladalkib is being studied in two recruiting trials. NCT05384626 is a Phase 1 study in advanced NSCLC and other solid tumors with ALK alterations. NCT06765109 is a Phase 3 study in TKI-naive patients with advanced ALK-positive NSCLC.
Yes, Neladalkib is also known as NVL-655. Both names refer to the same investigational drug developed by Nuvalent, Inc. for the treatment of ALK-driven cancers.