Radiotherapy to the primary lung tumor in metastatic NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Prime-Lung is a phase 3 randomized trial evaluating if targeted radiotherapy to the primary lung tumor, in addition to standard systemic therapy, can reduce metastasis and improve overall survival for newly diagnosed metastatic NSCLC. Participants receive standard-of-care systemic therapy with or without primary-tumor radiotherapy, with the aim of determining whether local treatment of the primary site can enhance systemic outcomes. The trial incorporates input from multiple specialties, including radiation and medical oncology, physics, biostatistics, health economics, and quality of life experts, to assess clinical benefit and cost-effectiveness. Eligibility focuses on adults with stage IV NSCLC whose disease has spread to up to three organ systems and who are suitable for systemic therapy. The study is conducted across several Australian centers and is sponsored by the Trans Tasman Radiation Oncology Group with TOGA collaboration.

Why it matters

Who can join: the full rules

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

Where it's running

• Peter MacCallam Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Blacktown Hospital
  Blacktown, New South Wales, Australia Not yet recruiting
• ICON Cancer Centre - Gold Coast University Hospital
  Gold Coast, Queensland, Australia Not yet recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Not yet recruiting
• Ballarat Austin Radiation Oncology Centre (BAROC)
  Ballarat, Victoria, Australia Not yet recruiting
• Sir Charles Gairdner Hospital
  Nedlands, Western Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: PRIME-Lung CRA
• Email: primelung@trog.com.au
• Phone: +61240143911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.