Monitoring Alectinib Treatment by Detection of ALK Transl... | NCT04708639

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

NCT04708639

Sponsor

Aarhus University Hospital

Status

Unknown status

Last Update Posted

Feb 2, 2021Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Lung Cancer
ALK Gene Mutation
Resistance, Disease
Mutation

Interventions

Alectinib

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2019Actual

Primary Completion Date

Jun 30, 2022Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2021

Last Update Posted Date

Feb 2, 2021Actual

Name	Class
Roche Pharma AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alectinib	Drug	Use of ctDNA to establish response and resistance to alectinib.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All newly diagnosed ALK translocated lung cancer adenocarcinomas.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Meldgaard, MD, PhD	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

All data will be published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D060467	Disease Resistance

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C582670	alectinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided