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Taking people in AustraliaPhase 3

Tests radiotherapy to the lung tumour with standard drugs in advanced lung cancer

Tests radiation to the main lung tumour plus drugs in adults with spreading lung cancer.

Key facts

Who runs it
Trans Tasman Radiation Oncology Group
Where
Adelaide, Ballarat, Blacktown, Gold Coast, Melbourne, and Nedlands, AustraliaSee the 6 sites
Trial code
Registry title
Primary Radiotherapy In MEtastatic Lung Cancer
Status
Recruiting
Phase
Phase 3
People taking part
420 people, planned
Started
30 Oct 2026
Expected to end
31 Dec 2036
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Radiotherapy followed by chemotherapy
  • Standard of Care (SOC)
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults newly diagnosed with stage IV non-small-cell lung cancer. They would have radiotherapy to the lung tumour as well as standard drug treatment.

Age
18 years or older
Sex
All sexes can join
Disease stage
Newly diagnosed stage IV (metastatic) non-small-cell lung cancer, with spread to up to 3 organ systems. Surgery or radiotherapy meant to remove all of the disease is not an option. The lung tumour can be treated with radiotherapy and does not need urgent palliative chest radiotherapy.
Earlier treatment
No chest radiotherapy of more than 36Gy in the 6 months before joining. The doctor must consider standard-of-care drug treatment appropriate.
Biomarker or test result
Cancer confirmed as non-small-cell lung cancer by tissue or cell tests. A cancer with an EGFR/ALK/ROS1 change, or another treatable driver mutation where targeted drugs will be used, cannot join.

Main reasons for not taking part

  • Too unwell for standard drug treatment
  • EGFR/ALK/ROS1 mutation or other treatable driver mutation with planned targeted drugs
  • Another cancer diagnosed or treated in the past 2 years, with some exceptions
  • Past or current pneumonitis needing steroids, or fibrotic interstitial lung disease
  • Brain metastases that are not controlled and cannot be treated by surgery or stereotactic radiotherapy

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Medically unfit for systemic 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
  • Uncontrolled brain metastasis not amenable to debulking surgery or stereotactic radiotherapy
  • 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
  • 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
  • EGFR/ALK/ROS1 mutation positive or actionable driver mutation with intention to use available targeted drug therapy

Where in Australia

  • Royal Adelaide HospitalAdelaide, AustraliaContact: Ryan AppletonNot yet recruiting
  • Ballarat Austin Radiation Oncology Centre (BAROC)Ballarat, AustraliaContact: Michelle BraybookNot yet recruiting
  • Blacktown HospitalBlacktown, AustraliaContact: Suganthy VaradarajanNot yet recruiting
  • ICON Cancer Centre - Gold Coast University HospitalGold Coast, AustraliaContact: Trial CoordinatorNot yet recruiting
  • Peter MacCallam Cancer CentreMelbourne, AustraliaContact: Trial CoordinatorTaking people
  • Sir Charles Gairdner HospitalNedlands, AustraliaContact: Eva ArnericNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm1: Standard of CareExisting treatment, for comparison

    Standard of care systemic chemotherapy

    Treatment: Standard of Care (SOC)

  • Arm 2: Standard of Care + Radiotherapy to primaryExisting treatment, for comparison

    Primary irradiation followed by standard of care systemic chemotherapy

    Treatment: Radiotherapy followed by chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Randomised Phase III Trial of Up-front Radiotherapy With Standard-of-care Systemic Therapy in Advanced Lung Cancer
Plain-language title
Tests radiotherapy to the lung tumour with standard drugs in advanced lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 October 2026