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Clinical Trials List

Protocol NumberM23-721
NCT Number(ClinicalTrials.gov Identfier)NCT06236438
Active

2024-05-01 - 2032-02-29

Phase II/III

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)

  • Trial Applicant

    AbbVie

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/17

Investigators and Locations

Principal Investigator Chao-Hua Chiu 無
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Cheng Chang 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

Phase 1 (Phase 2): The primary objective was to evaluate the safety and efficacy of livmoniplimab and budigalimab in combination with platinum-based doublet chemotherapy, and to select the Phase 3 recommended dose (RP3D) of livmoniplimab. Phase 2 (Phase 3): The primary objective was to evaluate the efficacy of the RP3D of livmoniplimab and budigalimab in combination with platinum-based doublet chemotherapy compared to pembrolizumab in combination with platinum-based doublet chemotherapy, based on overall survival (OS).

Test Drug

N/A
N/A

Active Ingredient

Budigalimab (ABBV-181)
Livmoniplimab (ABBV-151)

Dosage Form

N/A
N/A

Dosage

N/A

Endpoints

Phase 1 Key Achievements:
* Best Overall Response (BOR)* is defined as the achievement of a complete response (CR) or partial response (PR) as determined by the trial administrator at any time prior to subsequent anticancer therapy, according to RECIST 1.1.

* Phase 2 Key Achievements:
* Overall Survival (OS)* is defined as the time from randomization to death from any cause.

Inclution Criteria

Inclusion Criteria:

Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available.
Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/radiology assessment.
Life expectancy of at least 3 months and adequate organ function.

Exclusion Criteria

Exclusion Criteria:

- Received prior systemic therapy for the treatment of metastatic NSCLC.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    840 participants

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