A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
A Phase 2, Open-label, Randomized, Multi-arm Study of BGB-A445 in Combination With Investigational Agents in Non-Small Cell Lung Cancer Patients Previously Treated With Anti-PD-(L)1 Antibody
2 other identifiers
interventional
35
2 countries
18
Brief Summary
The main objective of this study was to evaluate the anti-tumor activity of gimistotug (BGB-A445) plus investigational agents in participants with non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Oct 2023
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedResults Posted
Study results publicly available
January 5, 2026
CompletedJanuary 5, 2026
December 1, 2025
1.2 years
August 24, 2023
December 12, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate
Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a confirmed complete response (CR) or partial response (PR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. CR is defined as: * Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. * Disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes must be nonpathological in size (\< 10 mm short axis). * No new lesions. PR is defined as: * At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Non-progressive disease with regard to non-target lesions, persistence of 1 or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. * No new lesions.
Response was assessed every 6 weeks for the first 9 months and every 12 weeks thereafter; maximum time on follow-up was up to 13.5 months
Secondary Outcomes (7)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Duration of Response (DOR)
From first dose to the end of study; maximum time on follow-up was up to 13.5 months.
Disease Control Rate (DCR)
From first dose to the end of study; maximum time on follow-up was up to 13.5 months
Clinical Benefit Rate (CBR)
Assessed from first dose to the end of the study. Response was assessed every 6 weeks for the first 9 months and every 12 weeks thereafter; maximum time on follow-up was up to 13.5 months
Serum Concentrations of Gimistotug
Cycle 1 Day 1 0.5 hours post-dose, Cycle 2 Day 1 predose, Cycle 5 Day 1 pre- and 0.5 hours post-dose, Cycle 9 Day 1 Predose, End of Treatment visit (30 days after last dose)
- +2 more secondary outcomes
Study Arms (2)
Gimistotug + Docetaxel
EXPERIMENTALParticipants received gimistotug and docetaxel 75 mg/m\^2 both by intravenous infusion once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
Gimistotug + BGB-15025
EXPERIMENTALParticipants received gimistotug by intravenous infusion once every 3 weeks and BGB-15025 orally once daily during each 3-week cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or other discontinuation criterion were met.
Interventions
75 milligrams per square meter (mg/m\^2) administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- Advanced or metastatic NSCLC (nonsquamous or squamous) that is histologically or cytologically confirmed
- Participants who have received no more than 2 lines of prior systemic therapies which must include anti-programmed cell death protein ligand-1 (anti-PD-(L)1) treatment and a platinum-based chemotherapy administered in combination with, or sequentially before or after the anti-PD-(L)1 treatment
- At least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function as indicated by laboratory values during screening
You may not qualify if:
- With mixed small cell lung cancer
- Has received prior therapy targeting OX40 or any other T-cell agonists
- Has received prior therapy containing docetaxel and/or ramucirumab for advanced or metastatic NSCLC
- Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before the first dose of study drug(s)
- Active leptomeningeal disease or uncontrolled and untreated brain metastasis
- NOTE: Other criteria may apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (18)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510405, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Affiliated Hospital of Jiangnan University South Campus
Wuxi, Jiangsu, 214122, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271099, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2023
First Posted
September 8, 2023
Study Start
October 23, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 5, 2026
Results First Posted
January 5, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.