A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

In Phase 2, study patients will be enrolled into 6 distinct cohorts:

- Cohort 2a: 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: 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: 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: 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: Patients with locally advanced or metastatic NSCLC harboring an ALK

rearrangement, not eligible for other Phase 2 cohorts.

- Cohort 2f: 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.