A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib

NCT04814667 | Completed

• 1 other identifier: LAROTRACKING
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized. This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.

Conditions

Solid Tumor, Adult; Locally Advanced Solid Tumor; Metastatic Cancer

Keywords

NTRK gene fusion; Larotrectinib; Neurotrophic Tyrosine Receptor Kinase gene fusion; NTRK rearrangements

Outcome Measures

Primary Outcomes (5)

• Clinical activity of larotrectinib

  Best objective response rate (BORR) (Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)

  From the date of the first larotrectinib dose until the date of objectively documented progression or date of subsequent anti-cancer therapy, whichever came first, assessed up to 60 months.

• Clinical activity of larotrectinib

  Duration of response (DOR) (Best overall response of Complete Response or Partial Response according to RECIST V1.1 classification i.e assessed by investigators)

  From the start of Complete Response or Partial Response (whichever response came first) until the date of observed disease progression or death due to any cause, whichever came first, assessed up to 60 months.

• Clinical activity of larotrectinib

  Time to response (TTR)

  From the start of larotrectinib treatment until the first evidence of Objective Response according to RECIST V1.1 classification i.e assessed by investigators), assessed up to 60 months. Time to response will be calculated for responders only.

• Clinical activity of larotrectinib

  Progression-free survival (PFS)

  From the start of Larotrectinib treatment until the date of first observed disease progression (radiological or clinical, whichever came first) or death due to any cause, whichever came first, assessed up to 60 months

• Clinical activity of larotrectinib

  Overall survival (OS)

  From the start of larotrectinib treatment until the date of death, due to any reason, assessed up to 60 months. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.

Secondary Outcomes (6)

• Clinicopathological features of patients with locally advanced or metastatic NTRK fusion cancer for whom a decision to treat with larotrectinib was made before enrolment.

  Through study completion, an average of 60 months.

• Diagnosis strategy for detection of NTRK fusions in the investigational centers

  Through study completion, an average of 60 months.

• Treatment(s) received prior to and after larotrectinib.

  From the first dose of larotrectinib until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months .

• Patterns of larotrectinib treatment

  From the start of larotrectinib treatment until the day of permanent discontinuation of larotrectinib (including death), assessed up to 60 months

• Safety of larotrectinib

  Through study completion, an average of 60 months.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with locally advanced or metastatic tumors with a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, treated with Larotrectinib

You may qualify if:

• Adult male or female patients
• Histological confirmed diagnosis of advanced/metastatic solid tumor type.
• Patients previously, currently or to be treated with Larotrectinib within the ATU/post-ATU period. Patient must be \> 25 years-old at time of larotrectinib start.
• Patients not opposed to collection of personal clinical data

Sponsors & Collaborators

• Centre Leon Berard: lead
• Bayer: collaborator

Study Sites (4)

CHU Amiens

Amiens, France

Location

Centre Georges Francois Leclerc

Dijon, France

Location

Centre Leon Berard

Lyon, France

Location

Chi Elbeuf Louviers

Saint-Aubin-lès-Elbeuf, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Armelle DUFRESNE

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 24, 2021
• Study Start: February 23, 2021
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: December 20, 2024

Record last verified: 2023-07

Locations

FR (4)