A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Inclusion Criteria:

   1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing>40 kg).

   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 cytologically confirmed
      locally advanced or metastatic NSCLC with ROS1 rearrangement.

      3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or
      metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.

   3. Prior anticancer treatment (except cohort 2a).

   4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1.
   Phase 2: Must have measurable disease according to RECIST 1.1.

   5. Adequate baseline organ function and bone marrow reserve.

Exclusion Criteria:

   1. Patient's cancer has a known oncogenic driver alteration other than ROS1.

   2. Known allergy/hypersensitivity to excipients of NVL-520.

   3. Major surgery within 4 weeks of first dose of study drug.

   4. Ongoing anticancer therapy.

   5. Actively receiving systemic treatment or direct medical intervention on another
   therapeutic clinical study.