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

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 3, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
NSCLC
Interventions
RADIATION

Radiotherapy

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

DRUG

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.

Trial Locations (6)

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

RECRUITING

Sunshine Hospital Western Health, Sunshine

3165

RECRUITING

Peter MacCallum Cancer Centre - Monash Cancer Centre, Bentleigh East

3550

RECRUITING

Peter MacCallum Cancer Centre - Bendigo, Bendigo

4102

NOT_YET_RECRUITING

Princess Alexandra Hospital, Woolloongabba

4215

NOT_YET_RECRUITING

Gold Coast University Hospital, Southport

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER