🏛️ Verified NIH Record • Updated 2026-06-16

Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH Treatment Trial) (NCT03213704)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

🩺 Plain-English Summary (8th-Grade Level)

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and have come back (relapased) or does not respond to treatment (refractory). Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (43 items) and avoid the listed exclusions (11 items).

Location: Children's Hospital of Alabama — Birmingham, Alabama

Age range: 12 Months to 21 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

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).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment
  • Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, \>= 14 days must have elapsed since last dose of corticosteroid
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease (GVHD) post bone marrow transplant are not eligible for this trial
  • Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
  • Patients who have received prior therapy with a specific inhibitor of TRK (including but not limited to entrectinib \[RXDX-101\], DS-6051b, and PLX7486) are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

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

📍 All Participating Trial Locations (124 Sites)

Showing the first 25 of 124 sites.

  • Children's Hospital of Alabama — Birmingham, Alabama
  • Providence Alaska Medical Center — Anchorage, Alaska
  • Banner Children's at Desert — Mesa, Arizona
  • Banner University Medical Center - Tucson — Tucson, Arizona
  • Arkansas Children's Hospital — Little Rock, Arkansas
  • Kaiser Permanente Downey Medical Center — Downey, California
  • Loma Linda University Medical Center — Loma Linda, California
  • Miller Children's and Women's Hospital Long Beach — Long Beach, California
  • Children's Hospital Los Angeles — Los Angeles, California
  • Valley Children's Hospital — Madera, California
  • UCSF Benioff Children's Hospital Oakland — Oakland, California
  • Kaiser Permanente-Oakland — Oakland, California
  • University of California Davis Comprehensive Cancer Center — Sacramento, California
  • UCSF Medical Center-Mission Bay — San Francisco, California
  • Children's Hospital Colorado — Aurora, Colorado
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
  • Yale University — New Haven, Connecticut
  • Alfred I duPont Hospital for Children — Wilmington, Delaware
  • Children's National Medical Center — Washington D.C., District of Columbia
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida
  • Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
  • Nicklaus Children's Hospital — Miami, Florida
  • AdventHealth Orlando — Orlando, Florida
  • Arnold Palmer Hospital for Children — Orlando, Florida

💰 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.

💡 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.
🏛️ View Official NIH Record ↗