OncoMatch/Clinical Trials/NCT04879121
Larotrectinib for the Treatment of NTRK Amplification Positive, Locally Advanced or Metastatic Solid Tumors
Is NCT04879121 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Larotrectinib Sulfate for locally advanced malignant solid neoplasm.
Treatment: Larotrectinib Sulfate — This phase II trial studies the effect of larotrectinib in treating patients with NTRK gene amplification positive solid tumors that have spread to nearby tissues or lymph nodes (locally advanced) or other places in the body (metastatic). Larotrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: NTRK1 amplification (>= 7 copies)
Required: NTRK2 amplification (>= 7 copies)
Required: NTRK3 amplification (>= 7 copies)
Disease stage
Metastatic disease required
Must have at least one measurable lesion as defined by RECIST v1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Eastern Cooperative Oncology Group (ECOG) score ≤ 3. If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky performance score (KPS) ≥ 70 %
Prior therapy
Must have received: standard therapy appropriate for tumor type and stage
Must have received prior standard therapy appropriate for tumor type and stage of disease, or, in the opinion of the investigator, is unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy
Cannot have received: tyrosine kinase inhibitors targeting TRK
Exception: Subjects who received less than 28 days of such treatment and discontinued because of intolerance or toxicity are eligible
Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. However, subjects who received less than 28 days of such treatment and discontinued because of intolerance or toxicity are eligible
Cannot have received: investigational agent or anticancer therapy
Investigational agent or anticancer therapy within 2 weeks prior to the planned start of larotrectinib or five half-lives, whichever is shorter, and without clinically significant toxicities from that therapy
Lab requirements
Kidney function
Serum creatinine < 2.0 x ULN or estimated glomerular filtration rate ≥ 30 mL/minute using the Cockcroft-Gault formula
Liver function
AST and ALT < 2.5 x ULN or < 5 x ULN if liver function abnormalities are due to underlying malignancy; Total bilirubin < 2.5 x ULN, except in cases of biliary obstruction. Subjects with a known history of Gilberts disease and an isolated elevation of indirect bilirubin are eligible
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) or < 5 x ULN if liver function abnormalities are due to underlying malignancy; Total bilirubin < 2.5 x ULN, except in cases of biliary obstruction. Subjects with a known history of Gilberts disease and an isolated elevation of indirect bilirubin are eligible; Serum creatinine < 2.0 x ULN or estimated glomerular filtration rate ≥ 30 mL/minute using the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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