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RECRUITINGPHASE2

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317•European Organisation for Research and Treatment of Cancer - EORTC

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Registration phase
•* Histologic or cytologic confirmation of NSCLC. If small-cell elements present, participant will be ineligible.
•* Synchronous oligometastatic disease at diagnosis - and still oligometastatic at registration into the study - defined as maximum 5 metastases, in maximum 3 organs. Hilar, mediastinal and/or supraclavicular lymph nodes are not considered as metastases.
•* Age at registration ≥18 years
•* Eastern Cooperative Oncology Group performance status (ECOG PS)/ World Health Organization (WHO) 0-1.
•* Hepatic function:
•* Serum total bilirubin ≤1.5x upper limit of normal (ULN), or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome
•* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3x ULN (or ≤5x ULN, if liver metastases)
•* Renal function:
•* Glomerular filtration rate (GFR) based on the modification of diet in renal disease (MDRD) equation ≥30 mL/min
+25 more criteria

Exclusion Criteria

•* Presence of malignant pleural, pericardial and/or peritoneal effusion.
•* Presence of leptomeningeal carcinomatosis.
•* Tumour known to be positive for EGFR exon 19 or 21 mutations, ALK translocations or ROS1 fusions.
•* Prior pneumonectomy, radiotherapy (including mediastinal radiotherapy), chemotherapy, immune-check inhibitors or targeted therapy for lung cancer within the last 3 years before registration.
•* Previously treated brain metastases that are radiologically non-stable.
•Notes:
•* Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate. These treated brain metastasis will count as metastasis in the definition of oligometastatic disease.
•* Symptomatic brain metastases should be treated with surgery and/or stereotactic radiotherapy/ radiosurgery as soon as possible after diagnosis. If surgery is considered it must be applied before enrolment. Radiotherapy can be performed at any time.
•* History of any solid or hematological malignancy in the past 3 years before registration.
•Exceptions include patients who underwent successful definitive treatment of basal or squamous cell carcinoma of the skin, or any in-situ carcinoma(s).
+21 more criteria

Locations (16)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

CHU Helora Pole Hospitalier Jolimont

Haine-Saint-Paul, Belgium

CHU Mont Godinne - UCL Namur

Yvoir, Belgium

CH de La Cote Basque - Saint Leon

Bayonne, France

Institut Paoli-Calmettes

Marseille, France

Groupe Hospitalier Paris Saint Joseph

Paris, France

ASST Ovest Milanese - Legnano

Legnano, Italy

Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

Legnano, Italy

Fondazione IRCCS - Policlinico San Matteo

Pavia, Italy

AUSL Della Romagna - Ospedale Santa Maria delle Croci

Ravenna, Italy

Key Dates

Start Date

January 14, 2025

Primary Completion Date

January 1, 2030

Completion Date

January 1, 2030

Last Updated

February 23, 2026

Enrollment

136

ESTIMATED participants

Conditions

NSCLC Stage IV

Interventions

Cemiplimab

DRUG

Placebo

DRUG

Contacts

EORTC

CONTACT

+32 2 774 1611 eortc@eortc.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

Inclusion Criteria

Exclusion Criteria

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