Volrustomig Priming Regimens Exploratory Phase II Platform Study

Non-small Cell Lung Cancer Clinical Trial

— eVOLVE-01  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448754
• Other study ID #: D798KC00001
• Secondary ID: 2023-509482-20
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 28, 2024
• Est. completion date: January 3, 2028

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 3, 2028
• Est. primary completion date: August 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Key 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.
• 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 Exclusion Criteria:

• 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 advanced disease are eligible, provided that progression has occurred greater (>) 12 months from end of last therapy.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Volrustomig
Participants will receive volrustomig via intravenous (IV) infusion.
• Carboplatin
Participants will receive carboplatin via IV infusion.
• Pemetrexed
Participants will receive pemetrexed via IV infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.	From screening (Days -28 to Day -1) up to 2.4 years
Primary	Objective Response rate (ORR)	ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).	Up to 2.4 years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.	Up to 2.4 years
Secondary	Duration of Response (DOR)	DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).	Up to 2.4 years
Secondary	Progression Free Survival (PFS)	PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).	Up to 2.4 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization or first dose until the date of death due to any cause.	Up to 2.4 years
Secondary	Serum Concentration of Volrustomig	The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.	Up to 2.4 years
Secondary	Trough concentration (Ctrough)	The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.	Up to 2.4 years
Secondary	Maximum Observed Concentration (Cmax)	The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.	Up to 2.4 years
Secondary	Area Under the Curve (AUC)	The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.	Up to 2.4 years
Secondary	Number of Participants with Positive Antidrug Antibodies (ADAs)	The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.	Up to 2.4 years