RecruitingPhase 1NCT05222087

PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study

PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

40 participants

Start Date

Jan 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Outcome for patients diagnosed with advanced lung cancer remains poor; alternative treatment options are urgently needed. Studies in other metastatic cancers indicate radiotherapy to the primary tumour can improve outcomes. The investigators postulate this will also be observed in lung cancer patients. The aim of this pilot study is to assess the safety and feasibility of stereotactic ablative radiotherapy (SABR) to the lung primary prior to standard of care (SoC) systemic therapy in advanced non-small cell lung cancer (NSCLC). Forty patients with advanced (Stage IV) NSCLC will be recruited across the five Peter Mac campuses. Patients will be randomised to receive SoC systemic therapy with or without radiotherapy to the lung primary. Radiotherapy will be delivered before cycle 3 of SoC systemic therapy. Biospecimens will be collected for future translational research. The primary outcome of the study (feasibility of the protocol) will be assessed by the ability to deliver radiotherapy to the lung cancer primary, whilst meeting dose constraints. The study will also 1) evaluate proportion of patients who are willing to be randomised; 2) describe toxicity during the follow up period in each arm; 3) describe progression free survival.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is exploring whether giving radiation therapy to the primary lung tumor (in addition to standard treatments) can help patients with newly diagnosed stage IV non-small cell lung cancer (NSCLC) live longer. **You may be eligible if...** - You are 18 or older - You have newly diagnosed stage IV (metastatic) non-small cell lung cancer that cannot be cured with surgery or full-dose radiation - Your cancer has been confirmed by a biopsy - You are well enough to receive treatment (good performance status) - You have not yet started systemic treatment for this diagnosis **You may NOT be eligible if...** - You have previously been treated for this lung cancer - Your tumor is not safely treatable with radiation - You have active autoimmune disease or certain other serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

35Gy/5# Central 40Gy/5# Large Tumours \>5cm (non-central) 36Gy/12# or 40Gy/15# Ultracentral lesions 50Gy/5# Peripheral Tumours ≤5cm

DRUGSoC systemic therapy

Permitted SoC chemoimmunotherapy for squamous patients will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Paclitaxel. Carbo/Paclitaxel/Pembro intravenous infusions are given every 3 weeks for cycle 1-4, followed by ongoing maintainence with Pembrolizumab from Cycle 5. For non-squamous patients, SoC chemoimmunotherapy will include single agent immunotherapy with Pembrolizumab or in combination with Carboplatin or Permetrexed. Carboplatin/Pemetrexed/Pembrolizumab infusions are given every 3 weeks for four cycles followed by maintenance with Pemetrexed/Pembrolizumab from Cycle 5.


Locations(6)

Gold Coast University Hospital

Southport, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Centre - Bendigo

Bendigo, Victoria, Australia

Peter MacCallum Cancer Centre - Monash Cancer Centre

Bentleigh East, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Sunshine Hospital Western Health

Sunshine, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05222087


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