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A Randomized Phase II Trial of Nivolumab, Cabozantinib Plus Nivolumab, and Cabozantinib Plus Nivolumab Plus Ipilimumab in Patients with Previously Treated Non Squamous NSCLC.

Research & Trial Information

SCHEMA EA5152

Protocol #: EA5152

Cancer Type: Non Small Cell Lung Cancer

Eligibility Criteria for Step 0:

1.

    • · ROS1 gene rearrangement by FISH or DNA analysis (may have progressed on prior crizotinib therapy)
  • · MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy)
  • · MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed)
  • · RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed)

 

Patients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine eligibility to Arm T. The Study Chair, Co-Chair, Biology Co-Chair, or a delegate must review the molecular testing and agree that the testing meets eligibility outlined below (please see Section 4.2.4 for instructions):

Institutions will be notified of the patient’s eligibility status for Arm T within two (2) business days of submission of the molecular testing reports.

If patients do not have tumors with the above molecular alterations noted proceed directly to Step 1.

Eligibility Criteria for Step 1:

  1. For patients with known molecular alterations, institution has been notified that patient is deemed eligible for Arm T per review of molecular testing reports.
  2. Pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC).
  3. Stage IV disease (includes M1a, M1b, or recurrent disease).
  4. Predominant non-squamous histology (patients with NSCLC NOS are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible.
  5. Tumors must be tested and known negative for EGFR TKI sensitizing mutations.
  6. Patients must have progressed radiographically following first line platinum-based chemotherapy, No additional lines of therapy are permitted.
  7. Patients must have measurable disease.
  8. No prior anti-MET therapy such as crizotinib or cabozantinib, or PD-1/PD-L1 immune checkpoint inhibitor therapy (such as nivolumab, pembrolizumab, atezolizumab) or CTLA4 inhibitor therapy (such as ipilimumab). No prior allergic reaction to small molecule tyrosine kinase inhibitors or monoclonal antibodies.
  9. Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to registration: Chemotherapy/ targeted oral therapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to registration; Any chemotherapy administered in an every 2 week or greater schedule must be completed ≥ 2 weeks prior to registration.
  10. No prior radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks prior to registration.
  11. Patients with no known brain metastasis must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases.
  12. Patients must have ECOG performance status 0-1.
  13. Patients must have anticipated life expectancy greater than 3 months.

 

 

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium

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