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

Who is this study for? Patients with metastatic lung cancer
What treatments are being studied? SoC systemic therapy+SABR
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Peter MacCallum Cancer Centre - Bendigo
RECRUITING
Bendigo
Peter MacCallum Cancer Centre - Monash Cancer Centre
RECRUITING
Bentleigh East
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Gold Coast University Hospital
NOT_YET_RECRUITING
Southport
Sunshine Hospital Western Health
RECRUITING
Sunshine
Princess Alexandra Hospital
NOT_YET_RECRUITING
Woolloongabba
Contact Information
Primary
Shankar Siva
shankar.siva@petermac.org
+613 85595000
Backup
CRDO
CRDO@petermac.org
+61 3 8559 8872
Time Frame
Start Date: 2022-01-03
Estimated Completion Date: 2025-04
Participants
Target number of participants: 40
Treatments
Active_comparator: Arm 1: SoC systemic therapy
Experimental: Arm 2: radiotherapy to lung primary, delivered before cycle three of SoC systemic therapy
Sponsors
Leads: Peter MacCallum Cancer Centre, Australia

This content was sourced from clinicaltrials.gov