Clinical Trial Information
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.
- Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC.
- 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.
- 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.
- 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.
- 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.
- Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted).
- Patients must have measurable disease.
- Patients must be able to swallow capsules.
- Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to substudy registration.
- Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy.
- 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.
- 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.
- Patients must have Zubrod performance status 0-1.