Network Integrated Platform for Clinical Trials Navigation from the New South Wales Early Phase Clinical Trials...

Access to early-phase clinical trials (EPCTs) is increasingly constrained by delays in genomic testing and lack of coordinated system-level navigation. The New South Wales Early Phase Clinical Trials Alliance (NECTA) was established to improve EPCT access. PANNA-COTA (Practical Assessment of NECTA Network Assistance in Cancer Outpatient Trials Access) prospectively evaluated whether integrating circulating tumour DNA (ctDNA) profiling with a real-time, cross-site molecular tumor board (MTB) facilitates EPCT enrolment.

In this multicentre prospective study across nine NECTA sites, patients referred for EPCT consideration underwent ctDNA testing using the Guardant360® 74-gene assay. Results were reviewed at a fortnightly MTB incorporating cross-site trial mapping and dynamic eligibility review. The primary endpoint was proportion enrolled into EPCTs. Secondary endpoints included ctDNA findings and trial outcomes.

Of 104 consented participants, 101 were eligible. Participants had advanced, heavily pre-treated solid tumours; 48% lacked prior tumour NGS. ctDNA alterations were detected in 85%, with actionable alterations in 44%. Therapeutic options were identified in 88%, and EPCTs were recommended in 76%. Despite this, only 7% of participants received genomically matched therapy. In contrast, 37% enrolled in EPCTs within 3 months and 47% overall (95% CI 0.37-0.56). Among enrolled participants, disease control rate was 81% and objective response rate 33%.

PANNA-COTA demonstrates that integrating liquid biopsy with real-time, network-level trial navigation enables high rates of EPCT enrolment despite low rates of genomically matched therapy. These findings indicate that clinical trial access is influenced by navigation, eligibility, and system-level coordination rather than genomic actionability alone.