RECRUITING Phase 3 ClinicalTrials.gov

Primary Radiotherapy In MEtastatic Lung Cancer

Sponsor: Trans Tasman Radiation Oncology Group • ClinicalTrials.gov ID: NCT07135882

Registry updated: 2026-10-14

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Description

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.

Interventions

Radiotherapy followed by chemotherapy (Combination product)
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
Standard of Care (SOC) (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Newly diagnosed metastatic (stage IV) NSCLC, not amenable to curative surgery or curative radiotherapy * Histologically or cytologically documented NSCLC * Primary suitable for radiotherapy and not requiring immediate palliative thoracic irradiation * Investigator deemed appropriate for SoC systemic therapy * Metastases in up to 3 organ systems Exclusion Criteria: * Medically unfit for systemic therapy * EGFR/ALK/ROS1 mutation positive or actionable driver mutation with intention to use available targeted drug therapy * Has had previous thoracic radiotherapy of \> 36Gy within the 6 months prior to randomisation. * Has been diagnosed and/or treated additional malignancy within 2 years prior to randomisation with the exception of: Curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated early-stage cervical cancer, breast cancer or prostate cancer with no evidence of active disease and not on active therapy. Other exceptions may be considered following consultation with the principal investigator * Has a history of (non-infectious) pneumonitis or current pneumonitis that requires active corticosteroids with a dose equivalent of prednisolone \> 10mg/d. * A known diagnosis of fibrotic interstitial lung disease * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Uncontrolled brain metastasis not amenable to debulking surgery or stereotactic radiotherapy * Has an active autoimmune disease that has required systemic treatment within last year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Locations

ICON Cancer Centre - Gold Coast University Hospital — Gold Coast, Queensland, Australia
Peter MacCallam Cancer Centre — Melbourne, Victoria, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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