Clinical trialPhase 2Completed
A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors
A Study to Learn How Well the Drug Larotrectinib Works in Adults With Different Solid Cancers With a Change in the Genes Called NTRK Fusion
- Outcome
- Finished, no results posted
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 30 September 2015
- Expected end
- 29 September 2025
- Enrollment
- 215 participants
- Sites
- 98
- Primary outcomes
- Best overall response of confirmed complete response (CR) or partial response (PR) as determined by an independent radiology review committee using RECIST v1.1 or RANO criteria, as appropriate to tumor type.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 1 July 2026
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Brief summary public domain (ClinicalTrials.gov)
This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.
Detailed description public domain (ClinicalTrials.gov)
The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults. Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.
Papers 19
- Builds on itCancer control after pausing treatment with larotrectinib in responding children with sarcoma and a TRK fusion: a plain… DOI 10.1080/14796694.2026.2711519↗
- Builds on itGastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. DOI 10.6004/jnccn.2025.0022↗
- Builds on itLarotrectinib Compared With Real-World Non-Tropomyosin Receptor Kinase Inhibitor Therapies in Patients With Tropomyosin… DOI 10.1200/po-24-00500↗
- Builds on itElective Discontinuation of Larotrectinib in Pediatric Patients With TRK Fusion Sarcomas and Related Mesenchymal Tumors. DOI 10.1200/jco.24.00848↗
- Builds on itComparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psorias… DOI 10.1007/s13555-024-01229-6↗
- Builds on itRevolutionizing cancer drug development: Harnessing the potential of basket trials. DOI 10.1002/cncr.35085↗
- Builds on itLarotrectinib efficacy and safety in adult patients with tropomyosin receptor kinase fusion sarcomas. DOI 10.1002/cncr.35036↗
- Builds on itSurvival Outcomes of Patients With Tropomyosin Receptor Kinase Fusion-Positive Cancer Receiving Larotrectinib Versus St… DOI 10.1200/po.22.00436↗
- Builds on itTesting methods to diagnose TRK fusion cancer - a plain language summary and patient perspective. DOI 10.2217/fon-2022-0863↗
- Builds on itEfficacy and safety of larotrectinib in TRK fusion-positive primary central nervous system tumors. DOI 10.1093/neuonc/noab274↗
- Builds on itLarotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers. DOI 10.1093/oncolo/oyac080↗
- Builds on itEfficacy and Safety of Larotrectinib in Patients With Tropomyosin Receptor Kinase Fusion-Positive Lung Cancers. DOI 10.1200/po.21.00418↗
- Builds on itNTRK and RET fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake. DOI 10.1172/jci144847↗
- Builds on itCanadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Adults. DOI 10.3390/curroncol28010053↗
- Builds on itCanadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Pediatric Patients. DOI 10.3390/curroncol28010038↗
- Builds on itLarotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. DOI 10.1016/s1470-2045(19)30856-3↗
- Builds on itTumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. DOI 10.1093/annonc/mdz385↗
- Builds on itEfficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. DOI 10.1056/nejmoa1714448↗
- Builds on itFGFR1 and NTRK3 actionable alterations in "Wild-Type" gastrointestinal stromal tumors. DOI 10.1186/s12967-016-1075-6↗