Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial) (NCT04268550)

🧪 Interventions in This Study

• Selpercatinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 as defined here:
2. Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (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 have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD)
7. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration
8. Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
9. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
10. Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration
11. Patients must be able to swallow capsules
12. Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (306 Sites)

Showing the first 25 of 306 sites.

• Fairbanks Memorial Hospital — Fairbanks, Alaska
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Kaiser Permanente-Anaheim — Anaheim, California
• Sutter Auburn Faith Hospital — Auburn, California
• Kaiser Permanente-Baldwin Park — Baldwin Park, California
• Kaiser Permanente-Bellflower — Bellflower, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Kaiser Permanente-Fontana — Fontana, California
• Palo Alto Medical Foundation-Fremont — Fremont, California
• Kaiser Permanente - Harbor City — Harbor City, California
• Kaiser Permanente-Irvine — Irvine, California
• Loma Linda University Medical Center — Loma Linda, California
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
• Kaiser Permanente-Cadillac — Los Angeles, California
• Palo Alto Medical Foundation-Camino Division — Mountain View, California
• Kaiser Permanente-Ontario — Ontario, California
• Palo Alto Medical Foundation Health Care — Palo Alto, California
• Stanford Cancer Institute Palo Alto — Palo Alto, California
• Kaiser Permanente - Panorama City — Panorama City, California
• Kaiser Permanente-Riverside — Riverside, California
• Sutter Roseville Medical Center — Roseville, California
• Sutter Medical Center Sacramento — Sacramento, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• Kaiser Permanente-San Diego Zion — San Diego, California
• California Pacific Medical Center-Pacific Campus — San Francisco, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Recurrent Lung Non-Small Cell Carcinoma

• Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer — Houston, Texas
• Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial) — Daphne, Alabama
• Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial) — Daphne, Alabama
• Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer — Scottsdale, Arizona
• NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer — Houston, Texas

Explore by condition: All Recurrent Lung Non-Small Cell Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.