NCT07135882RecruitingPhase 3
Primary Radiotherapy In MEtastatic Lung Cancer
A Randomised Phase III Trial of Up-front Radiotherapy With Standard-of-care Systemic Therapy in Advanced Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 30 Oct 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Diseases
- Lung cancer
- NCT number
- NCT07135882
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 420
- From 30 Oct 2026 to the primary completion date, 31 Dec 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- EGFR/ALK/ROS1 mutation positive or actionable driver mutation with intention to use available targeted drug therapy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Not yet recruiting |
| Ballarat Austin Radiation Oncology Centre (BAROC) Coordinator of this site? Confirm its status | Ballarat | Australia | Not yet recruiting |
| Blacktown Hospital Coordinator of this site? Confirm its status | Blacktown | Australia | Not yet recruiting |
| ICON Cancer Centre - Gold Coast University Hospital Coordinator of this site? Confirm its status | Gold Coast | Australia | Not yet recruiting |
| Peter MacCallam Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Sir Charles Gairdner Hospital Coordinator of this site? Confirm its status | Nedlands | Australia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.