- Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous NSCLC (includes M1a, M1b, M1c stage disease, AJCC 8th edition). ALK rearrangement must have been demonstrated by an FDA approved assay (Vysis FISH or Ventana IHC) or by next generation sequencing (NGS).
- Patient must be willing and able to undergo a fresh biopsy or if patient has a biopsy after progression on current TKI (and has continued TKI for clinical benefit per treating physician) this tissue may be used.
- Patient must have progressive disease as defined by RECIST 1.1
- ECOG performance status 0-2
- Patients must be able to take oral medications
- Major surgery within 2 weeks of study entry.Minor surgical procedures (eg, port insertion, pleurex catheter placement) are allowed and all wounds must not show signs of infection or draining.
- Radiation therapy (except palliative RT to relieve bone pain) within 2 weeks of study entry. Palliative RT (<10 fractions) must have been completed at least 48 hours prior to study entry
- Prior dose of next generation ALK inhibitor (LDK378 (ceritinib), alectinib, ensartinib, lorlatinib] within 5 days prior to step 2 registration. Prior dose of brigatinib within 7 days prior to step 2 registration.
- Patients must not plan to receive any other investigational agents during the course of therapy.
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.