Primary Radiotherapy In MEtastatic Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrans Tasman Radiation Oncology Group
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Radiotherapy followed by chemotherapy
- Standard of Care (SOC)
Treatment groups
420 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Trans Tasman Radiation Oncology Group
Lead sponsor
Thoracic Oncology Group of Australasia (TOGA)
Collaborator
Source ClinicalTrials.gov