Pegasus 2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2025-10-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To determine whether a functional planning guided by lung perfusion PET/CT imaging is superior to a conventional anatomical planning with regards to the occurrence of grade 2 or higher lung toxicity during the year following lung SBRT.

Secondary objectives 9

1. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to: 1) Quality of life;
2. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to: Frequency of grade 2 or higher RILI
3. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to:Grade 3 or higher RILI;
4. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to: Progression-free survival;
5. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to:Overall survival.
6. To compare a functional planning guided by lung perfusion PET/CT imaging and a conventional anatomical planning with regards to Progression-free survival
7. To assess the predictive value of the doses delivered to lung functional volumes as compared to the anatomical lung volume on long term lung toxicity at 12 months. For that purpose, lung perfusion PET/CT data from both arms (experimental and control) will be used
8. To assess the predictive value of the doses delivered to lung functional volumes as compared to the anatomical lung volume on lung perfusion PET/CT imaging at 3 months
9. To assess the predictive value of the decrease of lung perfusion at 3 months on long term lung toxicity at 12 months

Conditions and MedDRA coding

planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors.

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients aged > 18 years planned to be treated in the radiotherapy department of the participating centers with SBRT for primary or secondary lung tumors will be eligible to participate into the study

Exclusion criteria 3

1. inability to give informed consent
2. patients under guardianship or curatorship
3. pregnant or breastfeeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the occurrence of symptomatic RILI (grade≥2 lung toxicity as assessed using the CTCAE 5.0) during the year following lung SBRT. This evaluation will be performed by a medical oncologist blinded from the allocated arm.

Secondary endpoints 9

1. Quality of life as assessed by the EORTC QLQ-C30,EORTC QLQ-LC29 and EQ-5D-5L questionnaires at 3, 6, 9 and 12 months.
2. - Lung toxicity as assessed using the CTCAE 5.0, RTOG and Late effects in normal tissue-subjective objective management analysis (LENT-SOMA) scales at 3, 6, 9 and 12 months.
3. - Local tumor control.
4. - Progression-free survival at 3, 6, 9 and 12 months.
5. Overall survival at 12 months.
6. Grade 2 or higher lung toxicity as defined for the primary endpoint.
7. Lung perfusion PET/CT imaging at 3 months.
8. To assess the predictive value of the doses delivered to lung functional volumes as compared to the anatomical lung volume on lung perfusion PET/CT imaging at 3 months.
9. To assess the predictive value of the decrease of lung perfusion at 3 months on long term lung toxicity at 12 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

2 Avenue Marechal Foch

City

Brest

Postcode

29200

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Pr Pierre-Yves LE ROUX

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Clinical trial manager

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications