| Titre |
A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer |
| Protocole ID |
GALAXIES LUNG-201 |
| ClinicalTrials.gov ID |
NCT05565378 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
Belrestotug |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Khashayar Esfahani
|
| Coordonnateur(trice) |
Ashley Ceasar
514-340-8222 poste 22075
|
| Statut |
 Actif en recrutement |
| Date d'activation |
12-10-2023 |
| Critètes d'éligibilité |
- Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)
- No prior systemic therapy for their locally advanced or metastatic NSCLC
- Provides a fresh tumor tissue sample or recent archival sample collected within 2 years prior to screening
- PD-L1-high (TC/TPS ≥ 50%) tumor
- Measurable disease based on RECIST 1.1, as determined by the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Adequate baseline organ function
- Female participants of childbearing potential must use adequate contraception
|
| Critètes d'exclusion |
- Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphoma kinase (ALK) translocations, or other known genomic aberrations or oncogenic driver mutations for which a locally approved therapy is available. All participants with non squamous histology must have been tested for EGFR mutation and ALK translocation status
- Had major surgery within 4 weeks or lung radiation of >30 grays (Gy) therapy within 6 months prior to the first dose of study intervention
- Received prior therapy with any immune checkpoint inhibitors
- Never smoker, defined as smoking <100 tobacco cigarettes in a lifetime
- Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol)
- Symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
- Autoimmune disease or syndrome that required systemic treatment within the past 2 years
- Receiving any form of immunosuppressive medication
- Received any live vaccine ≤ 30 days prior to first dose of study intervention
- Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
- History or evidence of cardiac abnormalities ≤6 months prior to enrollment
- Current unstable liver or biliary disease
- Severe infection within 4 weeks prior to randomization
- Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions [e.g., pleural, pericardial, peritoneal])
- Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention
- Has a history of allogeneic tissue/stem cell transplant or solid organ transplant
|
Groupe d'étude en oncologie du Québec