Clinical Trials

22/001 DYNAMALK

DYNAMALK: ALK+ NSCLC: an Australian Dynamic ctDNA Profiling Study
Recruitment target:
30
Status:
Open to Recruitment
(Currently Recruiting)

Collaboration with:

AURORA

Summary:

Eventual resistance to ALKi therapy remains inevitable. There is currently no predictive or prognostic biomarker accepted or available in routine clinical practice to guide the personalised management of advanced ALK+ cases from diagnosis and with each line of therapy, nor is there wide and timely accessibility of a ctDNA genomic panel to enable such molecular data in Australia.

DYNAMALK aims to undertake molecular profiling via an Australian ctDNA study in treatment naïve and pre-treated ALK+ patients to describe and correlate ctDNA findings according to any prior therapies and temporal genomic profiles of patients recruited, to identify patterns of emerging resistance against clinical outcomes, and to report the influence of ctDNA genomic data obtained real time in informing clinical management over and above standard of care.

Clinical trial design:

Multi-centre, prospective non-interventional cohort study.

Indication:

ALK-mutation positive non-small cell lung cancer planned to initiate lorlatinib directly as next line of therapy as per Investigator’s discretion .

Intervention:

Collection of blood for real time ctDNA analysis at baseline, 6-12 weeks and 18 months.

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