Actively Recruiting
Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen
Led by Mario Negri Institute for Pharmacological Research · Updated on 2025-12-18
21
Participants Needed
9
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aim of this phase 2 study is to explore the safety and efficacy of thoracic re-irradiation +/- SBRT to oligometastases (\<3) followed after an interval of 2 weeks by durvalumab and ceralasertib for patients with thoracic relapses +/- oligometastases after PACIFIC or PACIFIC-like (concurrent or sequential chemo-radiotherapy followed by maintenance durvalumab) regimens.
CONDITIONS
Official Title
Phase II Study of Radiotherapy Followed by Durvalumab and Ceralasertib in Stage III NSCLC Patients With Thoracic Relapses +/- Oligometastases After PACIFIC Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and any required authorizations
- Male or female aged 18 years or older
- ECOG Performance Status of 0 to 2
- Life expectancy of 6 months or more at treatment start
- Body weight greater than 30 kg
- Maintenance treatment with durvalumab for at least 3 months
- Histologically or cytologically confirmed locally advanced NSCLC at relapse
- Measurable disease as defined by RECIST v1.1
- Documented tumor PD-L1 status at diagnosis or relapse
- Thoracic progression with up to 3 metastatic lesions suitable for local radiotherapy
- Interval of more than 12 months since end of first thoracic radiotherapy
- Pre-treatment whole body CT scan with intravenous contrast
- Pre-treatment CT-PET scan
- Pre-treatment brain MRI
- Female patients must be post-menopausal or have a negative pregnancy test
- Willingness and ability to comply with study procedures and visits
You will not qualify if you...
- Discontinued durvalumab due to progression within 12 months after chemoradiotherapy
- Experienced grade 3 or higher immune-related toxicity during durvalumab maintenance (except fully recovered endocrine toxicities) or grade 3 or higher radiation-induced pneumonitis
- Unresolved toxicities from previous cancer therapy except alopecia and vitiligo
- Toxicity that led to permanent discontinuation of prior immunotherapy
- More than 3 distant metastases (non-oligometastatic disease)
- Metastatic disease progression not suitable for radical radiotherapy (e.g., malignant ascites, pleural or pericardial effusion, diffuse skin or lung lymphangiosis, diffuse bone marrow metastasis, GI tract invasion, abdominal masses)
- Major surgery within 28 days before first study treatment dose (except palliative surgery for isolated lesions)
- Diagnosis of ataxia telangiectasia
- Presence of targetable genomic alterations such as EGFR, HER-2, MET exon14 skipping, ALK, ROS1, RET, or NTRK rearrangements
- Uncontrolled illness including infections, heart failure, hypertension, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting compliance
- Participation in another investigational clinical study within 4 weeks (except observational studies)
- Use of concurrent chemotherapy, immunotherapy, biological or hormonal cancer treatments
- Inadequate bone marrow or organ function as defined by specified lab values
- History of active primary immunodeficiency
- Active or prior autoimmune or inflammatory disorders except specific exceptions
- Pregnant or breastfeeding women, or patients of reproductive potential not using effective birth control
- History of allogenic organ transplantation
- Any condition interfering with study drug evaluation or patient safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 9 locations
1
ASST degli Spedali Civili di Brescia
Brescia, Italy
Not Yet Recruiting
2
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
3
IRCCS Ospedale Policlinico San Martino, Genova
Genova, Italy
Actively Recruiting
4
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
5
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Actively Recruiting
6
Azienda ospedaliera di Padova
Padova, Italy
Not Yet Recruiting
7
Azienda Ospedaliero - Universitaria di Parma
Parma, Italy
Not Yet Recruiting
8
University Hospital of Geneva
Geneva, Switzerland
Not Yet Recruiting
9
University Hospital Zurich
Zurich, Switzerland
Not Yet Recruiting
Research Team
I
Irene De Simone, Project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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