| Titre |
A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC). |
| Protocole ID |
eVOLVE-Lung02 |
| ClinicalTrials.gov ID |
NCT05984277 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Métastatique |
| Type étude |
Clinique |
| Médicament |
Volrustomig + chimiothérapie Versus pembrolizumab + chimiothérapie |
| Institution |
CISSS DE CHAUDIERE-APPALACHES
 HOTEL-DIEU DE LEVIS
143 rue Wolfe, Lévis, QC, G6V 3Z1
|
| Ville |
Beauceville |
| Investigateur(trice) principal(e) |
Dre Marie-Ève Boucher
|
| Coordonnateur(trice) |
Pierre Bédard
418-835-7121
|
| Statut |
 Actif en recrutement |
| Date d'activation |
11-04-2024 |
| Critètes d'éligibilité |
- Histologically or cytologically documented squamous or non-squamous NSCLC.
- Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
- Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.
- Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.
|
| Critètes d'exclusion |
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes are excluded.
- Spinal cord compression.
- Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
-
History of another primary malignancy except for:
- Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
|
Groupe d'étude en oncologie du Québec