NCT07135882

Primary Radiotherapy In MEtastatic Lung Cancer

A Randomised Phase III Trial of Up-front Radiotherapy Before Standard-of-care Systemic Therapy in Advanced Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 cases. Almost half of the cases present with metastatic disease, in whom average survival is less than two years despite recent advances with immunotherapy. Drug therapies alone have not been able to overcome this ceiling in survival. The primary lung tumour is a source of ongoing seeding of new metastatic (secondary) sites of disease, and we will test whether eradication of the primary tumour through non-invasive radiotherapy will limit metastases, enhance the effect of drug therapy and ultimately improve patient outcomes. Radiotherapy is a rapidly translatable solution to address this unmet need. In the Primary Radiotherapy In MEtastatic Lung cancer (PRIME-Lung) trial, patients with metastatic NSCLC will receive standard of care systemic therapy with or without radiotherapy to the primary lung tumour. We hypothesise that radiotherapy will improve overall survival above standard of care drug therapy. PRIME-Lung is a randomised controlled phase III clinical trial and will provide a definitive answer to this critical issue. The study team includes representation from radiation and medical oncology, physics, respiratory medicine, biostatistics, health economics and quality of life experts. The PRIME-Lung trial was designed in consultation with consumers to ensure acceptability and applicability to this area of unmet need. Furthermore, to accelerate rollout and accessibility, the trial will build on the existing AURORA lung cancer registry, leveraging the registry's established data management processes and over 25 already active sites. As radiotherapy is a pillar of oncology and widely available, upon successful completion of this trial we expect rapid translation into the community and widespread adoption of the trial results.

Conditions

• Carcinoma, Non-Small-Cell Lung (NSCLC)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Radiotherapy followed by chemotherapy	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
DRUG	Standard of Care (SOC)	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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-01-01
• Completion: 2033-01-01
• First posted: 2025-08-22
• Last updated: 2025-08-22