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Trial Summary

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

Acronym:

AcceleRET-Lung

ACTRN/NCT /ethics:

NCT04222972

Scientific title:

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

Sponsor / Cooperative group:

Hoffmann-La Roche

Trial & Patient Characteristics

Cancer TypeLung & mesothelioma
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-07-24
Anticipated End Date2026-06-26

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlison Richards
EmailAlison.Richards@sa.gov.au
Phone08 8206 4835
Principal InvestigatorChris Karapetis
Recruitment StatusRecruiting