Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion (REALTRK)

Registry for Molecular Testing, Treatment and Outcome of Patients With Locally Advanced or Metastatic Solid Tumors Harboring a Fusion of NTRK1, NTRK2 or NTRK3

The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3

Study Overview

• Status: Active, not recruiting
• Conditions: NTRK Family Gene Mutation

Detailed Description

The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2 or NTRK3 gene fusions, thereby generating real world evidence. It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK (Neurotrophic Tyrosine Receptor Kinase) fusion-positive cancer. All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer, irrespective of the type of antineoplastic treatment, will be documented. Data will be assessed at least 36 months per patient (i.e. until 36 months after inclusion of the last patient in the study). This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses. Intra-individual and inter-individual comparisons (for the latter, provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor) could be performed.

The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations.

• Study Type: Observational
• Enrollment (Actual): 88

Contacts and Locations

• Study Contact: Name: Beate Niemeier, Dr.; Phone Number: +49/76115242; Email: realtrk@iomedico.com

Study Locations

• Germany
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Frankfurt, Germany, 60389
    • Centrum fur Hamatologie und Onkologie Bethanien
  • Freiburg, Germany, 79110
    • Praxis für interdisziplinäre Onkologie & Hämatologie
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hannover, Germany, 30161
    • Onkologische Schwerpunktpraxis
  • Hannover, Germany, 30625
    • Gemeinschaftspraxis
  • Heilbronn, Germany, 74078
    • SLK Kliniken Heilbronn Klinik für Innere Medizin III
  • Kempten, Germany, 87439
    • Klinikum Kempten
  • Köln, Germany, 50674
    • PIOH - Praxis Internistische Onkologie und Hämatologie
  • Landsberg, Germany, 86899
    • Asklepios MVZ Bayern, Schwerpunkt Hämatologie/Onkologie
  • Lübeck, Germany, 23552
    • Onkologische Praxis am Marien-Krankenhaus
  • Mönchengladbach, Germany, 41066
    • Praxis für Onkologie
  • München, Germany, 81675
    • Klinikum rechts der Isar der TUM Innere Medizin II
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Medizinische Klinik A
  • Neuss, Germany, 41462
    • TZN - Tumorzentrum Niederrhein GmbH
  • Ravensburg, Germany, 88212
    • Studienzentrum Onkologie Ravensburg
  • Recklinghausen, Germany, 45659
    • Praxis und Tagesklinik für Onkologie und Hämatologie
  • Rosenheim, Germany, 83022
    • Klinikum Rosenheim
  • Schorndorf, Germany, 73614
    • Zentrum Ambulante Onkologie
  • Soest, Germany, 59494
    • MVZ Kloster Paradiese GbR
  • Ulm, Germany, 89073
    • MVZ für Hämatologie und Onkologie
  • Villingen-Schwenningen, Germany, 78052
    • Onkologie Schwarzwald-Alb
• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with advanced (locally advanced or metastatic) solid tumors harboring a NTRK1, NTRK2 or NTRK3 gene fusion

Description

Inclusion Criteria:

• Locally advanced or metastatic solid tumor with a documented NTRK gene fusion, based on a validated assay (according to current ESMO recommendations), or the provision of tumor material for central retesting
• Molecular pathology or molecular diagnostics report with details on NTRK gene fusion testing must be available
• Aged ≥ 18 years
• Signed and dated informed consent form (ICF) (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

Exclusion Criteria:

• Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland)
• Participation in a clinical trial with a TRK inhibitor before or at enrolment (liv-ing patients) or before inclusion (deceased patients)
• Deceased patients who have explicitly contradicted further use of data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
IC before start of any treatment; Informed consent (IC) before start of any treatment after diagnosis of NTRK fusion-positive cancer. All data after diagnosis of NTRK fusion-positive cancer are collected prospectively.
IC after start of any treatment; IC after start of any treatment after diagnosis of NTRK fusion-positive cancer. Data after study inclusion are collected prospectively and retrospectively.
Deceased patients; Patients deceased prior to study inclusion (no IC required). All data are collected retrospectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	Proportion of patients with CR or PR as best response	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and disease characteristics	Descriptive summary of demographics, patient and disease characteristics	36 months
Test methods used for diagnosis of a NTRK fusion-positive cancer	Description of test methods used for diagnosis of a NTRK fusion-positive cancer and results thereof	Day 1
Physician-reported factors affecting decision to test for NTRK fusion and treatment decision	Description of physician-reported factors affecting decision to test for NTRK fusion and treatment decision making after diagnosis of NTRK gene fusion	Day 1
Treatment reality after diagnosis of NTRK gene fusion	Description of all treatment lines given to the patient after diagnosis of NTRK gene fusion including: Type of treatment (Systemic TRK inhibitor treatments or Non-TRK inhibitor treatments), treatment duration, dosing, treatment modifications and reasons thereof, reasons for end of treatment.	36 months
Safety of TRK inhibitor treatments	Treatment-emergent AEs (i.e., AEs which occurred during a specific TRK inhibitor treatment and in the respective survival FU) will be calculated per patient (absolute and relative frequencies) and case-based (absolute frequencies). The occurrence of any (S)AE will be displayed overall and per CTCAE grade. Adverse drug reactions (ADRs) and AESIs will be displayed accordingly. Incidence of AEs (MedDRA Preferred Term (PT) by System Organ Class (SOC)) will be calculated accordingly for each type of AE/ADR.	36 months
Physician-reported evaluation of TRK inhibitor therapy	Description of physician-reported evaluation of TRK inhibitor therapy	Day 1
Disease-related symptoms	Description of courses of disease-related symptoms (weight loss, ECOG) after diagnosis of NTRK gene fusion (Only for patients of inclusion group I)	36 months
Disease control rate	Proportion of patients with CR, PR or SD as best response	36 months
Time to Response	Time from start of treatment to the first objective tumor response (e.g., tumor shrinkage of ≥30%) observed for patients who achieved a CR or PR	36 months
Duration of Response	Time from documentation of tumor response to disease progression or death from any cause	36 months
Progression-free survival	Time from start of treatment until disease progression or death	36 months
Overall Survival	Time from start of treatment until death of any cause	36 months
PFS ratio	ratio of PFS of the first treatment line with a TRK inhibitor to time to progression (TTP) in the preceding treatment line without a TRK inhibitor	36 months
Event-free survival	Time from start of treatment until PD or death	36 months

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Collaborators: Roche Pharma AG
• Investigators: Study Director: Benjamin Kasenda, PD Dr. Dr., Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 25, 2026

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: NTRK; NTRK-fusion; Neurotrophic Tyrosine Receptor Kinase; NTRK Gene Fusion
• Other Study ID Numbers: IOM-040444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No