A Phase II Study of LOXO-292 in Patients with RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung Map Sub-Study)

April 23, 2020

Clinical Trial Information

SCHEMA

PROTOCOL: SWOG-S1900B (Lung Map Sub-Study)

Please Note: Below is brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC.
  2. Patients must have RET fusion-positive NSCLC as determined by the FMI tissueassay or other tumor-based assays such as NGS, PCR, or FISH, or by cfDNA blood assay. Patients with RET fusions detected by IHC alone are not eligible. The testing must
    be done within a laboratory with CLIA, ISO/IEC, CAP, or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel.
  3. For patients whose prior therapy was for Stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for Stage I-III disease only (i.e. patient has not received any treatment for Stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. Nivolumab, Pembrolizumab, or Durvalumab) is allowed.
  4. Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression.
  5. Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration.
  6. Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted).
  7. Patients must have measurable disease.
  8. Patients must be able to swallow capsules.
  9. Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to substudy registration.
  10. Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
  11. Patients must not be planning to receive any concurrent chemotherapy,immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
  12. Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator.
  13. Patients must have Zubrod performance status 0-1.

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