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NOT YET RECRUITING
NCT07135882
PHASE3

Primary Radiotherapy In MEtastatic Lung Cancer

Sponsor: Trans Tasman Radiation Oncology Group

View on ClinicalTrials.gov

Summary

Lung cancer has the highest mortality rate of all cancers in Australia and is an area of unmet need. It starts in the lung (the primary tumour), and then spreads (metastasise) to other organs. The PRIME-Lung clinical trial will investigate if radiotherapy to the primary lung tumour, in addition to standard drug therapies, for patients with metastatic lung cancer will lead to less spread of cancer, prolong life, improve patient well-being and be cost-effective for the health care system.

Official title: A Randomised Phase III Trial of Up-front Radiotherapy Before Standard-of-care Systemic Therapy in Advanced Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2026-01-01

Completion Date

2033-01-01

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Radiotherapy followed by chemotherapy

Standard of care (SoC) regimens available on the Australian PBS or relevant practice framework (Ireland and Canada) as per usual standard clinical practice are allowable in this protocol as SoC regimens. Radiotherapy Techniques: * Highly conformal techniques (IMRT/VMAT) * High-precision techniques are allowed for non-centrally located primaries Radiotherapy Dose: \- Several fractionation schedules allowed; minimum biological effective dose approximating 50Gy (α/β ratio = 10); 50Gy in 20 fractions, 40Gy in 15 fractions, and 35Gy in 5 fractions

DRUG

Standard of Care (SOC)

Standard of care (SoC) regimens available on the Australian PBS or relevant practice framework (Ireland and Canada) as per usual standard clinical practice are allowable in this protocol as SoC regimens.