Informations générales (source: ClinicalTrials.gov)
A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination With Other Anticancer Agents in Participants With Solid Tumors (eVOLVE-01) (eVOLVE-01)
Interventional
Phase 2
AstraZeneca (Voir sur ClinicalTrials)
août 2024
juin 2027
12 août 2025
Purpose of this study is to assess the safety, tolerability, pharmacokinetics,
immunogenicity, and antitumor activity of volrustomig in combination with other
anticancer drugs in participants with specified solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 28/08/2025 14:15:04 | 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 - 14076 - Caen Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 76031 - Bois Guillaume - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94000 - Créteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no
deterioration.
- Life expectancy greater than or equal to (>=) 12 weeks.
- Adequate organ and bone marrow function.
- Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
- Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ
mNSCLC in substudy 2.
- Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
- 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 1L therapies.
- At least one measurable lesion not previously irradiated that can be accurately
measured at baseline as >= 10 millimeter (mm) in the longest diameter.
Key
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no
deterioration.
- Life expectancy greater than or equal to (>=) 12 weeks.
- Adequate organ and bone marrow function.
- Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.
- Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQ
mNSCLC in substudy 2.
- Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
- 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 1L therapies.
- At least one measurable lesion not previously irradiated that can be accurately
measured at baseline as >= 10 millimeter (mm) in the longest diameter.
Key
- Spinal cord compression.
- History of primary active immunodeficiency.
- Active or prior documented autoimmune or inflammatory disorders.
- Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at
least 14 days prior to start of study intervention. A minimum of 2 weeks must have
elapsed between the end of radiation therapy and study enrollment.
- Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants
who have received prior platinum-containing adjuvant, neoadjuvant, or definitive
chemoradiation for local disease are eligible, provided that progression has
occurred greater (>) 12 months from end of last therapy.