Status:
NOT_YET_RECRUITING
Primary Radiotherapy In MEtastatic Lung Cancer
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
Thoracic Oncology Group of Australasia (TOGA)
Conditions:
Carcinoma, Non-Small-Cell Lung (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 PRI...
Detailed Description
Lung cancer is the leading cause of cancer-related death and is the second most common cancer in both men and women in Australia, and globally. Non-small cell lung cancer (NSCLC) accounts for 85% of c...
Eligibility Criteria
Inclusion
- Newly diagnosed metastatic (stage IV) NSCLC, not amenable to curative surgery or curative radiotherapy
- Histologically or cytologically documented NSCLC
- EGFR/ALK/ROS1 Wild-type
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2033
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT07135882
Start Date
January 1 2026
End Date
January 1 2033
Last Update
August 22 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.