Trial Outcomes & Findings for A Retrospective Study to Determine the Incidence of NTRK Fusions. NTRK Study (NCT NCT04010240)

Results Overview

A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on NGS (Next-generation sequencing methods). NGS (Next-generation sequencing methods) method: DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay as previously described.

Recruitment status

COMPLETED

Target enrollment

3820 participants

Primary outcome timeframe

at baseline (i.e. at the time of tumor removal)

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Retrospective Cohort For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Retrospective cohort: Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.
Overall Study STARTED	3820
Overall Study COMPLETED	1521
Overall Study NOT COMPLETED	2299

Reasons for withdrawal

Reasons for withdrawal
Measure	Retrospective Cohort For eligible subject, tumor material will be tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Retrospective cohort: Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.
Overall Study IHC not performed	2299

Baseline Characteristics

Age was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors n=3820 Participants Tumor material was tested by immunohistochemistry (Pan-Trk ICH testing with mAb EPR17341). Tumor material tested positive were analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.
Age, Categorical <=18 years	0 Participants Age was not collected
Age, Categorical Between 18 and 65 years	0 Participants Age was not collected
Age, Categorical >=65 years	0 Participants Age was not collected
Sex: Female, Male Female	0 Participants Sex was not collected
Sex: Female, Male Male	0 Participants Sex was not collected
Region of Enrollment France	3820 participants n=3820 Participants

PRIMARY outcome

Timeframe: at baseline (i.e. at the time of tumor removal)

Population: Subjects with locally advanced/unresectable or metastatic solid tumors and for whom NGS (new generation sequencing) was performed

A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on NGS (Next-generation sequencing methods). NGS (Next-generation sequencing methods) method: DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay as previously described.

Outcome measures

Outcome measures
Measure	Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors and NGS Performed. n=2378 Participants NGS / Next-generation sequencing methods : DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay.
Count of Participants With NRTK Fusions Among Participants Analyzed by NGS (Next-generation Sequencing).	11 Participants

SECONDARY outcome

Timeframe: at baseline (i.e. at the time of tumor removal)

Population: Participants with positive IHC results

A participant with NRTK fusion is defined as a participant with a tumor harboring NTRK1, NTRK2 or NTRK3 gene fusions, based on Immunohistochemistry (IHC). Immunohistochemistry (IHC) mehtod : Pan-TRK: rabbit monoclonal antibody, clone C17F1, Cell signaling dilution 1/50°. Automate Benchmark: ULTRA Ventana, CC1 64', incubation 52', revelation kit Optiview

Outcome measures

Outcome measures
Measure	Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors and NGS Performed. n=79 Participants NGS / Next-generation sequencing methods : DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay.
Count of Participants With NRTK Fusions Among Participants With With Positive Immunohistochemistry (IHC)	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Two years after tumor removal

Population: Only one patient had positive IHC results and had a gene NRTK fusion.

PFS is calculated using Kaplan-Meier method, in the population of patients with positive IHC results.

Outcome measures

Outcome measures
Measure	Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors and NGS Performed. n=1 Participants NGS / Next-generation sequencing methods : DNA and RNA were extracted from tumor tissue according to standard procedures. All samples had their RNA analyzed with Archer or full RNA sequencing to assess specific novel NTRK1, 2, and 3 rearrangements for the production of NTRK fusion transcripts. Alternatively, DNA was analyzed by using an hybrid-capture based NGS assay.
Progression-free Survival (PFS) in Patients With NRTK Gene Fusion.	NA years insufficient number of participants with events : There was only 1 patient with positive IHC results and had a gene NRTK fusion.

Adverse Events

Subjects With Locally Advanced/Unresectable or Metastatic Solid Tumors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Antoine Italiano

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: 0556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place