Share
Save
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
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.
Study details:
PRIME-Lung is an open-label randomised pilot study designed to assess the safety and feasibility of radiotherapy to the lung primary prior to commencement of standard of care (SOC) systemic therapy in advanced lung cancer. The study is designed to assess the feasibility of the protocol, and will be escalated, without major modification, directly to a randomised phase III design. This will occur if the following objectives are met in ≥ 66% of patients:.
1. Receipt of radiotherapy before cycle 3 of systemic therapy. 2.
Ability to meet dose constraints in delivering radiotherapy to the lung primary. The secondary objectives are:. * Evaluate proportion of patients who are willing to be randomized.
* To describe toxicity within 90 days of RT delivery. * To describe progression free survival Blood samples for future translational research will also be established. Newly diagnosed patients with advanced (Stage IV) non-small cell lung cancer (NSCLC) who have received no prior lines of systemic therapy will be invited to participate (refer to protocol for full inclusion/exclusion criteria).
Consenting patients will be randomised to either:. * Arm 1: Systemic therapy alone. * Arm 2: Radiotherapy before cycle 3 of systemic therapy.
The trial treatment is therefore the addition of radiotherapy before cycle 3 of SOC systemic therapy. During treatment (standard and experimental arm) participants will be assessed for radiation toxicity and the occurrence of adverse events. The recruitment period is over 18 months, with study visits at Baseline, radiotherapy (patients in Arm 2 only), Cycle 3 of SOC systemic therapy, 12 and 24 weeks after initiation of therapy, and at disease progression.
SOC CT Staging scans will occur every 6 weeks from initiation of SOC systemic therapy.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-01-03
Primary completion: 2025-04-01
Study completion finish: 2025-04-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05222087
Intervention or treatment
RADIATION: Radiotherapy
DRUG: SoC systemic therapy
Conditions
- • NSCLC
Find a site
Closest Location:
Gold Coast University Hospital
Research sites nearby
Select from list below to view details:
Gold Coast University Hospital
Southport, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre - Bendigo
Bendigo, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Arm 1: SoC systemic therapy
| DRUG: SoC systemic therapy
|
EXPERIMENTAL: Arm 2: radiotherapy to lung primary, delivered before cycle three of SoC systemic therapy
| RADIATION: Radiotherapy
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design. | To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design. Technical feasibility will be assessed by the ability to deliver radiotherapy to the lung cancer primary whilst meeting dose constraints tumour prior to cycle 3 of SoC systemic therapy in metastatic NSCLC. Radiotherapy to the primary in stage IV NSCLC will be considered worthwhile to be assessed in a large randomised study if radiotherapy is feasible in \>66% of patients randomised to the radiotherapy arm. | 18 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| willingness to be randomised | evaluate the proportion of patients who are willing to be randomised after being approached for the study. | 18 months |
| safety of Radiotherapy addition using NCI CTCAE | The safety of the addition of radiotherapy by describing toxicity during the follow up period in each arm. Safety will be measured as adverse events (AE) and serious adverse events (SAEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | 24 months |
| PFS | The study will also describe progression free survival within 6 months of follow-up. PFS defined as the time from randomisation to the first occurrence of disease progression, as determined by the Investigator following principles of RECIST 1.1, or death from any cause, whichever occurs first. | 24 months |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!