Actively Recruiting
Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-02-23
136
Participants Needed
16
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment. Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.
CONDITIONS
Official Title
Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or cytologic confirmation of NSCLC without small-cell elements
- Synchronous oligometastatic disease at diagnosis with maximum 5 metastases in up to 3 organs
- Age 18 years or older
- ECOG performance status 0-1
- Serum total bilirubin 1.5x upper limit of normal (ULN), or 3x ULN if liver metastases or Gilbert syndrome
- AST and/or ALT 3x ULN (or 5x ULN if liver metastases)
- Glomerular filtration rate (GFR) 30 mL/min based on MDRD equation
- Hemoglobin 9.0 g/dL
- Absolute neutrophil count (ANC) 1.5 x 10^9/L
- Platelet count 100 x 10^9/L
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to first dose
- Agree to use adequate birth control during treatment and for at least 6 months after last dose
- Women breastfeeding must discontinue nursing before first dose and until at least 6 months after last dose
- Capable of giving signed informed consent
- Stable disease, partial or complete response after 4 cycles of induction and radical treatment
- Anticipated life expectancy over 12 weeks
You will not qualify if you...
- Presence of malignant pleural, pericardial, or peritoneal effusion
- Presence of leptomeningeal carcinomatosis
- Tumor positive for EGFR exon 19 or 21 mutations, ALK translocations, or ROS1 fusions
- Prior pneumonectomy, radiotherapy, chemotherapy, immune-check inhibitors, or targeted therapy for lung cancer within 3 years
- Previously treated brain metastases that are radiologically unstable
- History of any solid or hematological malignancy in past 3 years except certain skin or in-situ carcinomas
- Any uncontrolled illness or infection grade 3 or higher
- Autoimmune disease requiring systemic treatment in past 2 years
- Known active hepatitis B or C
- Known active HIV infection with more than 200 copies/ml
- History of interstitial lung disease or non-infectious pneumonitis needing systemic glucocorticoids
- Immunosuppressive corticosteroid use over 10 mg prednisone daily within 2 weeks before treatment
- Participation in another clinical study with investigational drug/device within 4 weeks
- Allergic reaction or hypersensitivity to antibody treatments or study components
- Psychological, familial, sociological, or geographical conditions limiting compliance with study
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Actively Recruiting
2
CHU Helora Pole Hospitalier Jolimont
Haine-Saint-Paul, Belgium
Actively Recruiting
3
CHU Mont Godinne - UCL Namur
Yvoir, Belgium
Actively Recruiting
4
CH de La Cote Basque - Saint Leon
Bayonne, France
Actively Recruiting
5
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
6
Groupe Hospitalier Paris Saint Joseph
Paris, France
Not Yet Recruiting
7
ASST Ovest Milanese - Legnano
Legnano, Italy
Not Yet Recruiting
8
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, Italy
Actively Recruiting
9
Fondazione IRCCS - Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
10
AUSL Della Romagna - Ospedale Santa Maria delle Croci
Ravenna, Italy
Actively Recruiting
11
Azienda Ospedaliero - Universitaria "Santa Maria della Misericordia" di Udine
Udine, Italy
Actively Recruiting
12
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Actively Recruiting
13
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
Actively Recruiting
14
UOMi Cancer Center
Barcelona, Spain
Actively Recruiting
15
Hospital Quironsalud Sagrado Corazon
Seville, Spain
Actively Recruiting
16
University Hospital Virgen del Rocio
Seville, Spain
Not Yet Recruiting
Research Team
E
EORTC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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