Study identifier:D798KC00001
ClinicalTrials.gov identifier:NCT06448754
EudraCT identifier:N/A
CTIS identifier:2023-509482-20-00
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)
Non-small Cell Lung Cancer
Phase 2
No
Volrustomig, Carboplatin, Pemetrexed
All
120
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
-
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.
This is a platform, randomized, open-label, multicenter, global study. Enrolled participants with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease. These participants will be randomized in a 1:1 ratio to one of the two treatment arms: Arm 1A and Arm 1B. Both arms will test a volrustomig dosing in combination with chemotherapy.
Location
Status
Location
Genève 14, Switzerland, 1205
Status
Recruiting
Location
Dijon, France, 21079
Status
Not yet recruiting
Location
Verona, Italy, 37134
Status
Recruiting
Location
Seoul, Republic of Korea, 06591
Status
Recruiting
Location
Tbilisi, Georgia, 0144
Status
Recruiting
Location
Tbilisi, Georgia, 0114
Status
Recruiting
Location
Barcelona, Spain, 08041
Status
Recruiting
Location
Batumi, Georgia, 6010
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed. | Drug: Volrustomig Participants will receive volrustomig via intravenous (IV) infusion. Other Name: MEDI5752 Drug: Carboplatin Participants will receive carboplatin via IV infusion. Drug: Pemetrexed Participants will receive pemetrexed via IV infusion. |
Experimental: Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. | Drug: Volrustomig Participants will receive volrustomig via intravenous (IV) infusion. Other Name: MEDI5752 Drug: Carboplatin Participants will receive carboplatin via IV infusion. Drug: Pemetrexed Participants will receive pemetrexed via IV infusion. |
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