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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05222087
Ethics application status
Date submitted
6/01/2022
Date registered
3/02/2022

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
1/04/2025
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05222087