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Primary Radiotherapy In MEtastatic Lung Cancer

Not Yet RecruitingPhase 3

Sponsor: Trans Tasman Radiation Oncology Group

Conditions: Carcinoma, Non-Small-Cell Lung (NSCLC)

Interventions: Radiotherapy followed by chemotherapy, Standard of Care (SOC)

Countries: Australia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (2)

Gold Coast, Queensland, Australia
Melbourne, Victoria, Australia