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Protocol NumberD798KC00001
Active

2024-11-15 - 2027-02-16

Phase II

Recruiting4

ICD-10C00.0

Malignant neoplasm of external upper lip

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9140.0

Malignant neoplasm of upper lip, vermilion border

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)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator kang-Yun LEE Division of General Internal Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsin Hsiao
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Solid Tumors

Objectives

To assess the safety and tolerability of volrustomig priming regimens in combination with other anticancer drugs in participants with specified solid tumors.

Test Drug

N/A

Active Ingredient

Volrustomig

Dosage Form

N/A

Dosage

N/A

Endpoints

• Safety and tolerability will be evaluated in terms of
AEs/SAEs, ECOG performance status, clinical laboratory
findings, ECGs, vital signs, physical examinations, and
exposure.
• The analysis will include participants in the Safety
Analysis Set. Participants will be analyzed according to
the treatment they actually received.

Inclution Criteria

- 美國東岸癌症臨床研究合作組織 (ECOG) 體能狀態為 0 或 1 且未惡化。
- 預期壽命大於或等於 (>=) 12 週。
- 具有足夠的器官和骨髓功能。
- 篩選時和隨機分配時體重超過 (＞) 35 公斤 (kg)。
- 經組織學或細胞學證實患有非鱗狀細胞 (NSQ) 非小細胞肺癌 (NSCLC)（子試驗 1），以及鱗狀細胞 (SQ) 或 NSQ 轉移性非小細胞肺癌 (mNSCLC)（子試驗 2）。
- 缺乏致敏性表皮生長因子受體 (EGFR) 突變。
- 透過作為當地標準實務一部分而對有當地核准標靶第 1 線 (L) 療法之任何其他可採取行動的驅動因子致癌基因進行的檢測，顯示並無腫瘤基因體變異結果記錄。
- 至少有一處先前未接受放療的可測量病灶，可在基準期時準確測量為最長直徑大於或等於 (>=) 10 毫米 (mm )。

Exclusion Criteria

- 脊髓壓迫。
- 有原發性活動性免疫缺乏症的病史。
- 活動性或先前有記錄的自體免疫或發炎性疾病。
- 混合型小細胞肺癌和 NSCLC 組織學或肉瘤樣變異。
- 腦部轉移，除非無症狀、穩定且在開始試驗治療前至少 14 天內不需要類固醇。放射療法結束與試驗納入之間必須間隔至少 2 週。
- 曾為第 IV 期 NSCLC 接受化療或任何其他全身性療法。曾因局部疾病接受含鉑輔助性、前導輔助性或確定性化學放射療法的受試者可符合資格，前提是惡化在最後一次療法結束後超過 (＞) 12 個月發生。

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    180 participants

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