Informations générales (source: ClinicalTrials.gov)
A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer
Interventional
Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
novembre 2024
mai 2030
05 avril 2025
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell
lung cancer for whom surgery is planned.
The aim is to find out whether an investigational treatment (consisting of the
immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than
cemiplimab plus chemotherapy without the additional drug.
The study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in
comparison to the control treatment?
- Do the investigational treatments or the control treatment have an effect on the
type of surgery that is performed?
- How much of the study drug(s) are in the blood at a given time?
- Does the body make antibodies against the study drugs (which could make the drugs
less effective or could lead to side effects)?
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | 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 Hospitalier de la Cote Basque - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Intercommunal Toulon - CHITS - 83055 - Toulon - Var - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble Alpes - 38330 - Grenoble - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered
resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for
submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol
General Key
1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered
resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for
submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol
General Key
1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described
in the protocol
2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR)
or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as
described in the protocol
3. Presence of ≥ grade 2 peripheral neuropathy
4. Another malignancy that is progressing or requires active treatment, as described in
the protocol
Arm Specific Exclusion Criteria:
Arm 1:
1. Grade ≥3 hypercalcemia, as defined in the protocol
2. Any central nervous system (CNS) pathology that could increase the risk of immune
effector cell-associated neurotoxicity syndrome (ICANS), as described in the
protocol
3. Has marked baseline prolongation of the time from the start of the Q wave to the end
of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk
factors for prolonged QTc, as described in the protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply.