Primary Radiotherapy In MEtastatic Lung Cancer

NCT07135882 | Not Yet Recruiting Phase 3

• 1 other identifier: TROG 21.10
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Carcinoma, Non-Small-Cell Lung (NSCLC)

Keywords

Non-Small Cell Lung Cancer; Lung Neoplasms; Lung Cancer; Clinical reseach; Radiation Therapy; Advanced lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  To assess the overall survival of patients receiving SoC systemic therapy with or without radiotherapy to the primary lung tumour

  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

  2-years after the last participant has been randomised

• Progression Free Survival

  2-years after the last participant has been randomised

• Cancer specific survival

  2-years after the last participant has been randomised

• Patient Reported Quality of Life (QoL) assessed using EORTC QLQ-C30 questionnaire

  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

  2-years after the last participant has been randomised

Study Arms (2)

Arm1: Standard of Care

ACTIVE COMPARATOR

Standard of care systemic chemotherapy

Drug: Standard of Care (SOC)

Arm 2: Standard of Care + Radiotherapy to primary

ACTIVE COMPARATOR

Primary irradiation followed by standard of care systemic chemotherapy

Combination Product: Radiotherapy followed by chemotherapy

Interventions

Radiotherapy followed by chemotherapy COMBINATION_PRODUCT

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

Also known as: Standard of Care, Chemotherapy, Immunotherapy

Arm 2: Standard of Care + Radiotherapy to primary

Standard of Care (SOC) DRUG

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.

Also known as: chemotherapy, immunotherapy

Arm1: Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead
• Thoracic Oncology Group of Australasia (TOGA): collaborator

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Standard of Care; Drug Therapy; Immunotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Immunomodulation; Biological Therapy

Study Officials

• Shankar Siva

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Central Study Contacts

PRIME-Lung CRA

CONTACT

+61240143911; primelung@trog.com.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2033
• Last Updated: August 22, 2025

Record last verified: 2025-08