Non-small Cell Lung Cancer Clinical Trial
— eVOLVE-01Official 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)
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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AstraZeneca |
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 |
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