Radiotherapy for advanced lung cancer before standard treatment
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study
This study is testing if giving a special type of radiation treatment before regular therapy can help people with advanced lung cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peter MacCallum Cancer Centre, Australia Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Southport, Queensland and 5 other locations) |
| Trial ID | NCT05222087 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and feasibility of delivering stereotactic ablative radiotherapy (SABR) to the primary tumor in patients with advanced non-small cell lung cancer (NSCLC) prior to standard systemic therapy. Forty patients will be recruited and randomized to receive either standard systemic therapy alone or systemic therapy with prior radiotherapy. The study will assess the feasibility of the protocol based on the ability to deliver radiotherapy before the third cycle of systemic therapy and will also collect biospecimens for future research. Secondary objectives include evaluating patient willingness to participate and monitoring toxicity and progression-free survival.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, metastatic (stage IV) non-small cell lung cancer who have not received prior systemic therapy.
Not a fit: Patients with EGFR/ALK/ROS1 mutations or those who are medically unfit for systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced lung cancer.
How similar studies have performed: Other studies in different metastatic cancers have shown that radiotherapy to the primary tumor can improve outcomes, suggesting potential success for this approach in lung cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have provided written informed consent for the trial. * Be ≥ 18 years of age on day of signing informed consent. * Newly diagnosed, metastatic (stage IV), non-small cell lung cancer (NSCLC), not amenable to curative surgery or curative radiotherapy * Histological or cytologically documented NSCLC * EGFR/ALK/ROS1 Wild-type * Primary disease suitable for radiotherapy and not requiring immediate palliative irradiation * ECOG 0-1 Exclusion Criteria: * Medically unfit for systemic therapy * EGFR/ALK/ROS1 mutation positive * Has had previous thoracic radiotherapy of \> 36Gy in 12 fractions (or equivalent) within the 6 months prior to randomisation. * Has diagnosed and/or treated additional malignancy within 3 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. 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. * Has had any systemic anti-cancer therapy within 4 weeks prior to randomisation * A known diagnosis of idiopathic pulmonary fibrosis * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Uncontrolled brain metastases defined as not amenable to surgery or stereotactic radiotherapy
Where this trial is running
Southport, Queensland and 5 other locations
- Gold Coast University Hospital — Southport, Queensland, Australia (Not_yet_recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Not_yet_recruiting)
- Peter MacCallum Cancer Centre - Bendigo — Bendigo, Victoria, Australia (Recruiting)
- Peter MacCallum Cancer Centre - Monash Cancer Centre — Bentleigh East, Victoria, Australia (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- Sunshine Hospital Western Health — Sunshine, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Shankar Siva, A/Prof — Peter MacCallum Cancer Centre, Australia
- Study coordinator: Shankar Siva
- Email: shankar.siva@petermac.org
- Phone: +613 85595000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.