Informations générales (source: ClinicalTrials.gov)
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). (eVOLVE-Lung02)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
octobre 2023
mai 2029
24 septembre 2024
The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the
safety of volrustomig in combination with chemotherapy compared with pembrolizumab in
combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:37 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Jaafar BENNOUNA | 21/10/2024 07:07:28 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| Research Site - 29000 - Quimper cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 35403 - Saint-Malo - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Research Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Research Site - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Research Site - 67098 - Strasbourg Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75248 - Paris Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 84902 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92150 - Suresnes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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.
Key
- 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.
Key
- 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:
1. 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.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
3. 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.