Study

Recruiting Not a phased study

Sources: ClinicalTrials.gov Checked: 12 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Bayer
Registry number NCT04142437
Started 3 April 2020 Today 16 October 2026 Estimated completion 30 November 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Many Locations Many Locations Australia Withdrawn

voxsanity.com.au · trial sites from public registries · registry record synced 12 October 2026 · not medical advice

Who can join

Age child, adult, older adult
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 150

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Adult and pediatric (from birth to 18-year-old) patients

* Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.

* Life expectancy of at least 3 months based on clinical judgement

* Decision to treat with larotrectinib made by the treating physician prior to study enrollment

* Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date

* Signed informed consent form

* For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

* Any contraindications as listed in the local approved product information

* Pregnancy

* Participation in an investigational program with interventions outside of routine clinical practice

* Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition

* Patients with NTRK gene amplification or NTRK point mutation

Dates on the record

Started 3 April 2020
Estimated completion 30 November 2029
Registry last updated 2 October 2026
Checked by Voxsanity 12 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 2 October 2026.
  • This page last checked by Voxsanity: 12 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.