A Study of Zidesamtinib (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).

2. Disease Criteria:

3. Phase 1: Histologically or cytologically confirmed locally advanced ormetastatic solid tumor with documented ROS1 rearrangement.

4. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmedlocally advanced or metastatic NSCLC with ROS1 rearrangement.

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

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

7. 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.

8. 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 anothertherapeutic clinical study.