Volrustomig Priming Regimens Exploratory Phase II Platform Study - eVOLVE-01
Study identifier:D798KC00001
ClinicalTrials.gov identifier:NCT06448754
EudraCT identifier:N/A
CTIS identifier:2023-509482-20-00
Recruiting
Official Title
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)
Medical condition
Non-small Cell Lung Cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Volrustomig, Carboplatin, Pemetrexed, Ramucirumab, Paclitaxel
Sex
All
Estimated Enrollment
180
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 27 Aug 2024
Estimated Primary Completion Date: 30 Jun 2027
Estimated Study Completion Date: 30 Jun 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Substudy 1: 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: Substudy 1: Arm 1B: 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. |
| Experimental: Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel Volrustomig priming dose + ramucirumab + histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel). | 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. Drug: Ramucirumab Participants will receive ramucirumab via IV infusion. Drug: Paclitaxel Participants will receive paclitaxel via IV infusion. |
