Informations générales (source: ClinicalTrials.gov)
A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC
Interventional
Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
juillet 2024
avril 2029
25 juin 2025
This study is researching an experimental drug called fianlimab (also called REGN3767)
with two other medications called cemiplimab and platinum-doublet chemotherapy,
individually called a "study drug" or collectively called "study drugs", when combined in
this study. The study is being conducted in patients who have resectable stage II to IIIB
(N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.
The aim of the study is to see how effective the combination of fianlimab, cemiplimab,
and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative
therapy in participants with NSCLC.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much of each study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the
drugs less effective or could lead to side effects)
- How administering the study drugs might affect quality of life
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Ambroise Paré | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Oncologie de Gentilly - 54000 - Nancy - Grand Est - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes Hopital Guillaume et Rene Laennec - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon - 21000 - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - 87042 - Limoges - Nouvelle Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de l'Ouest - 44805 - Saint Herblain - Nantes - France | Contact (sur clinicalTrials) | ||||
| Uneos - Hopital R Schuman - 57070 - Metz - Vantoux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II
to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph
node sampling is required as defined in the protocol
3. All patients must have disease status showing no evidence of distant metastases
documented by a complete physical examination and imaging studies performed within 4
weeks prior to randomization as defined in the protocol
4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1)
immunohistochemistry (IHC) result as defined in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, hepatic and kidney function as defined in the protocol
Key
1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II
to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph
node sampling is required as defined in the protocol
3. All patients must have disease status showing no evidence of distant metastases
documented by a complete physical examination and imaging studies performed within 4
weeks prior to randomization as defined in the protocol
4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1)
immunohistochemistry (IHC) result as defined in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, hepatic and kidney function as defined in the protocol
Key
1. Any evidence of locally advanced unresectable or metastatic disease as defined in
the protocol
2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene
mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the
protocol
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or
hepatitis C virus (HCV) infection as defined in the protocol
4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy,
radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant
hormonotherapy used for breast cancer or other hormone-sensitive cancers in long
term remission is allowed.
5. Patients with a history of myocarditis
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply