Clinical Trials List
2024-05-01 - 2032-02-29
Phase II
Recruiting4
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) – LIVIGNO-4
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃振洋 Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- Chan-Keng Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chian-Wei Chen Division of General Internal Medicine
- Chun-Hui Lee Division of Hematology & Oncology
- Chin-Wei Kuo Division of General Internal Medicine
- Shang-Yin Wu Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- Seu-Chun Yang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
N/A
Active Ingredient
Livmoniplimab (ABBV-151)
Dosage Form
N/A
Dosage
N/A
Endpoints
Best overall response (BOR): Defined as achieving complete response (CR) or
partial response (PR) according to RECIST 1.1 as determined by the investigator
at any time prior to subsequent anticancer therapy.
Secondary Endpoints:
Progression-free survival (PFS) as determined by investigator, duration of
response (DOR) as determined by investigator, and overall survival (OS).
Inclution Criteria
Consent
1. Subjects or their legally authorized representative must voluntarily sign and date an informed
consent, approved by an independent ethics committee (IEC)/institutional review board (IRB),
prior to the initiation of any screening or study-specific procedures.
Demography and Laboratory Assessments
2. Subject is willing to comply with procedures required in this protocol.
3. Subject must be at least 18 years old.
4. Laboratory values meeting the following criteria within the screening period prior to the first
dose of study drug:
• Serum AST and ALT < 2.5 times upper limit of normal (ULN) OR 5 times ULN for subjects with
liver metastases/tumor infiltration.
• Bilirubin < 1.5 times ULN OR direct bilirubin ≤ULN for subjects with total bilirubin levels
> 1.5 × ULN
• Absolute neutrophil count ≥ 1000/mm3 with exception for groups with benign ethnic
neutropenia,10 then > 700/mm3
Exclusion Criteria
Subject History
1. Has predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the
predominant cell type and the subject would be eligible only if the standard of care regimen is
based on non-squamous histology; if small cell elements are present, the subject is ineligible.
2. History of additional malignancy or history of prior malignancy, except for adequately treated
basal or squamous skin cancer, cervical carcinoma in situ, or bladder carcinoma in situ without
evidence of disease, or malignancy treated with curative intent and with no evidence of disease
recurrence for 5-years since the initiation of that therapy.
3. History of clinically significant medical conditions or any other reason that the investigator
determines would interfere with the subject's participation in this study or would make the
subject an unsuitable candidate to receive study drug.
4. Prior allogeneic stem cell or solid organ transplantation.
5. History of an allergic reaction or significant sensitivity to constituents of the study drug (and
its excipients) and/or other products in the same class
6. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion
proteins.
7. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the
budigalimab or livmoniplimab formulation.
8. Subject is currently enrolled in another interventional clinical study or was previously enrolled
in this study.
9. Active infection requiring systemic therapy within 1 week prior to the anticipated first dose of
study treatment.
• Controlled HIV. Subjects infected with HIV may be enrolled if the following criteria are met:
CD4 count is >100 cells/µL. (If CD4 count is < 200 cells/µL, a CD4 to CD8 ratio > 0.4 is
required.) Subject has been receiving effective ART for at least 4 weeks with an HIV viral
load of less than 200 copies/mL, and subject has no symptomatic AEs higher than Grade 1
attributed to ART.
10. Active or prior documented history of positive test result(s) for hepatitis B (HBV) surface
antigen or for hepatitis C (HCV) antibody. NOTE: subjects who have a positive HCV antibody test
are eligible if HCV RNA is undetectable at screening.
The Estimated Number of Participants
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Taiwan
36 participants
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Global
840 participants
