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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
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
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.
ICON Cancer Centre - Gold Coast University Hospital
Gold Coast, Queensland, Australia
Peter MacCallam Cancer Centre
Melbourne, Victoria, Australia
Overall survival
To assess the overall survival of patients receiving SoC systemic therapy with or without radiotherapy to the primary lung tumour
Time frame: 5 years after the last participant was recruited
Thoracic toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
To assess the safety of the addition of radiotherapy by describing thoracic toxicities of interest during the follow up period in each arm (as assessed by NCI CTCAE v5.0) and to describe the discontinuation rate of systemic therapy and reasons for discontinuation
Time frame: 2-years after the last participant has been randomised
Progression Free Survival
To assess the likelihood of progression, or death, in each arm
Time frame: 2-years after the last participant has been randomised
Cancer specific survival
To assess death from cancer-related causes in each arm
Time frame: 2-years after the last participant has been randomised
Patient Reported Quality of Life (QoL) assessed using EORTC QLQ-C30 questionnaire
To compare the effect of treatment on overall QOL, at each time point (baseline, 3, 6, 12, and 24 months) between trial arms, collected on European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) questionnaire.
Time frame: 2-years after the last participant has been randomised
Cost effectiveness of RT plus SoC compared with SoC alone with respect to the incremental cost per quality-adjusted life year (QALYs) gained
Patient-specific costs associated with accessing care, particularly those associated with travel time for attendance, will be assessed based on questionnaires. QALYs, the combined impact of lung cancer and its treatment on survival and QoL, will be estimated by using the EORTC QLU-C10D (derived from the EORTC QLQ-C30) and EQ-5D-5L.
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Time frame: 2-years after the last participant has been randomised