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

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04708639
• Collaborator: Roche Pharma AG (Industry)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 72.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; ALK Gene Mutation; Resistance, Disease; Mutation	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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
• Actual Study Start Date: Jun 19, 2019
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2025

Outcome Measures

Primary Outcome Measures

1. PFS on alectinib [46 month]

   time from initiation of treatment to progression

2. mechanism of resistance [15.2 month]

   ctDNA to establish resistance mechanisms to alectinib treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8200

Sponsors and Collaborators

• Aarhus University Hospital
• Roche Pharma AG

Investigators

• Principal Investigator: Peter Meldgaard, MD, PhD, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Meldgaard, MD PhD, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT04708639
• Other Study ID Numbers: ML40920
• First Posted: Jan 14, 2021
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Lung Neoplasms; Disease Resistance

Study Results

No Results Posted as of Feb 2, 2021