Volrustomig Priming Regimens Exploratory Phase II Platform Study
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06448754
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed Carboplatin Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed. Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed Pemetrexed Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed. Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed Carboplatin Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed Pemetrexed Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. Arm 1 B Volrustomig dose regimen 2 + Carboplatin and Pemetrexed Volrustomig Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed. Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed Volrustomig Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) From screening (Days -28 to Day -1) up to 2.4 years The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Objective Response rate (ORR) Up to 2.4 years 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).
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) Up to 2.4 years 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.
Duration of Response (DOR) Up to 2.4 years 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).
Overall Survival (OS) Up to 2.4 years OS is defined as the time from randomization or first dose until the date of death due to any cause.
Trough concentration (Ctrough) Up to 2.4 years The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Progression Free Survival (PFS) Up to 2.4 years 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).
Serum Concentration of Volrustomig Up to 2.4 years The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Area Under the Curve (AUC) Up to 2.4 years 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.
Number of Participants with Positive Antidrug Antibodies (ADAs) Up to 2.4 years The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
Maximum Observed Concentration (Cmax) Up to 2.4 years The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
Trial Locations
- Locations (2)
Research Site
🇮🇹Verona, Italy
Research Site
🇨🇳Taipei, Taiwan