Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients (MonAlec)

Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Cancer; ALK Gene Mutation; Resistance, Disease; Mutation
• Intervention / Treatment: Drug: Alectinib

Detailed Description

The purpose and objectives of the non-interventional study with primary data collection is

• To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
• To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
• To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All newly diagnosed ALK translocated lung cancer adenocarcinomas.

Description

Inclusion Criteria:

1. Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
2. Written (personally dated and signed) informed consent

Exclusion Criteria:

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS on alectinib	time from initiation of treatment to progression	46 month
mechanism of resistance	ctDNA to establish resistance mechanisms to alectinib treatment	15.2 month

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Peter Meldgaard, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2019
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Disease Resistance
• Other Study ID Numbers: ML40920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: All data will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No