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RecruitingInterventionalPhase 2

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)

NCT ID: NCT06448754Sponsor: AstraZenecaLast updated: 2026-06-11

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 Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types. This platform study currently includes 2 substudies: Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous \[NSQ\]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B. Substudy 2: mNSCLC (squamous \[SQ\] or NSQ). Participants will enroll to the Arm 2A only. All arms will test a volrustomig dosing in combination with chemotherapy.

Arms & interventions

  • DrugVolrustomig

    Participants will receive volrustomig via intravenous (IV) infusion.

  • DrugCarboplatin

    Participants will receive carboplatin via IV infusion.

  • DrugPemetrexed

    Participants will receive pemetrexed via IV infusion.

  • DrugRamucirumab

    Participants will receive ramucirumab via IV infusion.

  • DrugPaclitaxel

    Participants will receive paclitaxel via IV infusion.

Outcome measures

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.

    Time frame: From screening (Days -28 to Day -1) up to 2 year 10 months

  • Confirmed Objective Response rate (ORR)

    ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

    Time frame: Up to 2 year 10 months

Secondary

  • Disease Control Rate (DCR)

    Time frame: Up to 2 year 10 months

  • Duration of Response (DOR)

    Time frame: Up to 2 year 10 months

  • Progression Free Survival (PFS)

    Time frame: Up to 2 year 10 months

  • Overall Survival (OS)

    Time frame: Up to 2 year 10 months

  • Serum Concentration of Volrustomig

    Time frame: Up to 2 year 10 months

  • Trough concentration (Ctrough)

    Time frame: Up to 2 year 10 months

  • Maximum Observed Concentration (Cmax)

    Time frame: Up to 2 year 10 months

  • Area Under the Curve (AUC)

    Time frame: Up to 2 year 10 months

  • Number of Participants with Positive Antidrug Antibodies (ADAs)

    Time frame: Up to 2 year 10 months

Eligibility criteria

Sex: AllAge: 18 Years to 130 YearsHealthy volunteers: No
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 in substudy 1 and SQ or NSQ mNSCLC in substudy 2. * 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 local disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.

Study locations (7)

Research Site

Los Angeles, California, 90067

Completed

Research Site

Grand Junction, Colorado, 81501

Withdrawn

Research Site

Wheat Ridge, Colorado, 80033

Withdrawn

Research Site

Baltimore, Maryland, 21231

Withdrawn

Research Site

Detroit, Michigan, 48202

Withdrawn

Research Site

Chapel Hill, North Carolina, 27514

Active Not Recruiting

Research Site

Tacoma, Washington, 98405

Withdrawn
Volrustomig Priming Regimens Exploratory Phase II Platform Study | Cancerify