Clinical Trial Title A Biomarker-Driven Protocol for Previously Treated ALK-Positive Non-Squamous NSCLC Patients: The NCI-NRG ALK Master Protocol (NCT03737994)
Trial Status Closed to Enrollment
Start Date 04/01/2019
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Lung Cancer
Description This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether a combination of biomarker/ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer.
Eligibility Criteria

Eligibility Criteria

  • 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

Ineligibility Criteria

  • 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.

IRB Number Central IRB
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail