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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05222087




Registration number
NCT05222087
Ethics application status
Date submitted
6/01/2022
Date registered
3/02/2022
Date last updated
18/03/2024

Titles & IDs
Public title
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study
Scientific title
PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer. A Pilot Study
Secondary ID [1] 0 0
80476
Universal Trial Number (UTN)
Trial acronym
PRIME_LUNG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiotherapy
Treatment: Drugs - SoC systemic therapy

Active Comparator: Arm 1: SoC systemic therapy -

Experimental: Arm 2: radiotherapy to lung primary, delivered before cycle three of SoC systemic therapy -


Treatment: Other: Radiotherapy
35Gy/5# Central 40Gy/5# Large Tumours >5cm (non-central) 36Gy/12# or 40Gy/15# Ultracentral lesions 50Gy/5# Peripheral Tumours =5cm

Treatment: Drugs: SoC 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the feasibility of the study design to be escalated without major modification directly to a randomised phase III design.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
willingness to be randomised
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
safety of Radiotherapy addition using NCI CTCAE
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
PFS
Timepoint [3] 0 0
24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Bendigo - Bendigo
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Monash Cancer Centre - Bentleigh East
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [6] 0 0
Sunshine Hospital Western Health - Sunshine
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment postcode(s) [4] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
3000 - Sunshine

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05222087
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shankar Siva, A/Prof
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shankar Siva
Address 0 0
Country 0 0
Phone 0 0
+613 85595000
Fax 0 0
Email 0 0
shankar.siva@petermac.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05222087