Stage IV non-small cell lung cancer Cancer
Conditions
Interventions
PRINCE is a randomised control trial in the TOURIST Platform. Patients may be identified at any point after the diagnosis of stage IV NSCLC by their usual care team. To permit timely randomisation and
Sponsors
The Christie NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. >=16 years of age 2. Stage IV non-small cell lung cancer (NSCLC) (radiological diagnosis confirmed at multidisciplinary team [MDT] as a minimum) (additionally see #6 trial-specific requirement below) 3. Thoracic disease amenable to radiotherapy 4. Provision of written informed consent 5. For women of childbearing potential: a negative urine or serum pregnancy test within 7 days of trial entry into the main trial 6. Histologically or cytologically confirmed NSCLC 7. At least T2 and/or N1 disease 8. ECOG Performance Status (0-2) 9. The patient is deemed fit to receive a minimum of four cycles of systemic anti-cancer treatment according to local guidelines and assessment 10. Fit to receive high-dose palliative radiotherapy with acceptable pulmonary function according to local guidelines and assessment
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 28/04/2026: 1. The need for palliative radiotherapy to the thorax prior to randomisation 2. Co-morbidities which are considered a contraindication to radiotherapy by the treating clinical team, including interstitial lung disease and active connective tissue disorders 3. History of prior malignant tumours likely to interfere with the protocol treatment or comparisons 4. Leptomeningeal disease 5. Women who are pregnant or breastfeeding 6. Women of child-bearing potential who are not able or unwilling to use a highly effective method of contraception 7. Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol 8. Primary targeted systemic therapy for NSCLC with a driver mutation (EGFR, ALK, ROS-1, BRAF) 9. Prior treatments for this NSCLC* 10. Patients participating in a clinical trial of an investigational medicinal product *Some treatments, delivered in the weeks prior to randomisation are acceptable (examples include: cycles 1 & 2 of standard of care systemic therapy, symptom directed (non-thoracic) palliative radiotherapy e.g. Stereotactic Radio-Surgery). Previous key exclusion criteria: 1. The need for palliative radiotherapy to the thorax prior to randomisation 2. Co-morbidities which are considered a contraindication to radiotherapy by the treating clinical team, including interstitial lung disease and active connective tissue disorders 3. History of prior malignant tumours likely to interfere with the protocol treatment or comparisons 4. Leptomeningeal disease 5. Women who are pregnant or breastfeeding 6. Women of child-bearing potential who are not able or unwilling to use a highly effective method of contraception 7. Patients who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol 8. Primary targeted systemic therapy for NSCLC with a driver mutation (EGFR, ALK, ROS-1, BRAF) 9. Prior treatments for this NSCLC* 10. Patients participating in a clinical trial of an investigational medicinal product *Cycle 1 of standard-of-care systemic therapy for this NSCLC may be delivered prior to randomisation
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival (OS), defined as time from randomisation to death from any cause. Censored at the last follow-up if event-free 2. Progression-free survival (PFS), defined as time from randomisation to disease progression (RECIST v1.1) or death from any cause. Censored at last follow-up if event-free 3. Quality of life using EORTC QLQ-C30 and EQ-5D-5L. Questionnaires completed: Screening/Baseline, month 4, month 6, month 9, month 12, month 15, month 21 4. Lung cancer symptoms using EORTC QLQ-LC13. Questionnaire completed: Screening/Baseline, month 4, month 6, month 9, month 12, month 15, month 21 5. Acute and late toxicity as assessed using NCI CTCAE v5.0. From informed consent to end of study | — |
Primary
| Measure | Time frame |
|---|---|
| Health utility measured using EORTC QLU-C10D Area Under the Curve (AUC; using trapezoidal rule) to derive a health utility score per year. Questionnaires completed: Screening/Baseline, week 4, week 6, week 8, week 12, week 14, month 4, month 6, month 9, month 12, month 15, month 18, month 21. | — |
Countries
England, Ireland, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactIzabela Eberhart
Outcome results
None listed