Primary Radiotherapy In MEtastatic Lung Cancer

Official record

Identifier

NCT07135882

Recruiting locations

country

Australia

Interventions studied

Radiotherapy followed by chemotherapyStandard of Care (SOC)

Lead sponsor

Trans Tasman Radiation Oncology Group

Target enrolment

420 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Not yet recruiting

First posted

Aug 22, 2025

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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