Carcinoma, Non-Small-Cell Lung (NSCLC)Phase 3PRIME-LungNCT07135882
Primary Radiotherapy In MEtastatic Lung Cancer
A Phase 3 study testing Radiotherapy followed by chemotherapy in people with Carcinoma, Non-Small-Cell Lung (NSCLC), run by Trans Tasman Radiation Oncology Group at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung (NSCLC)
- What is being tested?
- Radiotherapy followed by chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 6 sitesAustralia
- Study dates
- 30 Oct 2026to 31 Dec 2036
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Ryan Appleton, 08 7074 0151, Ryan.Appleton@sa.gov.au
Hien Le
- Not yet recruiting
Ballarat Austin Radiation Oncology Centre (BAROC)
Ballarat, Victoria, 3350
Michelle Braybook, 03 53 208562, Michelle.brayborok@gh.org.au
Jonathan Tomaszewski
- Not yet recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
Suganthy Varadarajan, (02) 86705075, Suganthy.Varadarajan@health.nsw.gov.au
Eric Hau
- Not yet recruiting
ICON Cancer Centre - Gold Coast University Hospital
Gold Coast, Queensland, 4215
Trial Coordinator, +61756342400, sharon.hewett@icon.team
Andrew Dr Oar
- Recruiting
Peter MacCallam Cancer Centre
Melbourne, Victoria, 3000
Trial Coordinator, +61385597777, DIVYA.ARORA@petermac.org
Tom Prof John
- Not yet recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Eva Arneric, 08 6383 3195, Eva.Arneric@health.wa.gov.au
Nicholas Bucknell
About this study
Official title: A Randomised Phase III Trial of Up-front Radiotherapy With Standard-of-care Systemic Therapy in Advanced Lung Cancer
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.
Read the 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)
- Being tested
- Radiotherapy followed by chemotherapy, Standard of Care (SOC)
- Keywords
- Non-Small Cell Lung Cancer, Lung Neoplasms, Lung Cancer, Clinical reseach, Radiation Therapy, Advanced lung cancer
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy followed by chemotherapyCombination product
Also called Standard of Care, Chemotherapy, Immunotherapy
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)Drug
Also called chemotherapy, immunotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Standard of Care | Active comparator | Standard of care systemic chemotherapy Receives: Drug: Standard of Care (SOC) |
| Arm 2: Standard of Care + Radiotherapy to primary | Active comparator | Primary irradiation followed by standard of care systemic chemotherapy Receives: Combination Product: Radiotherapy followed by chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To assess the overall survival of patients receiving SoC systemic therapy with or without radiotherapy to the primary lung tumour
Measured: 5 years after the last participant was recruited
Secondary outcomes (5)
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
Measured: 2-years after the last participant has been randomised
Progression Free Survival
To assess the likelihood of progression, or death, in each arm
Measured: 2-years after the last participant has been randomised
Cancer specific survival
To assess death from cancer-related causes in each arm
Measured: 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.
Measured: 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.
Measured: 2-years after the last participant has been randomised
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start30 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell Lung (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Thoracic Oncology Group of Australasia (TOGA)
- Responsible party
- Sponsor
- Investigators
- Shankar Siva, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135882
- Sponsor's protocol ID
- TROG 21.10
- Other IDs
- TOGA 20-005, U1111-1327-4520
- Acronym
- PRIME-Lung
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Australian data will be collected using established Lung Cancer registry (AURORA). The trial sponsor is not the custodian of this registry, therefore is able to confirm IPD data can be shared at this stage.