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Non-Small Cell Lung CancerPhase 2NCT06029127

A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer

A Phase 2 study testing Gimistotug, Docetaxel and BGB-15025 in people with Non-Small Cell Lung Cancer, run by BeiGene at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Gimistotug, Docetaxel and BGB-15025
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
18 sitesin 2 countries
Study dates
23 Oct 2023to 31 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

China15 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510405

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong, 271099

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Weihai Municipal Hospital

    Weihai, Shandong, 264299

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Affiliated Hospital of Jiangnan University South Campus

    Wuxi, Jiangsu, 214122

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

South Korea3 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722

  • The Catholic University of Korea, St Vincents Hospital

    Suwon, Gyeonggi-do, 16247

Other trials in South Korea

About this study

Official title: 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

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).

Read the detailed description

This study tested whether gimistotug in combination with other agents could help treat participants with non-small cell lung cancer (NSCLC) who were already treated with other anticancer agents, including anti-programmed cell death protein-1 (anti-PD-1) and anti-programmed cell death protein ligand-1 (anti-PD-L1) antibodies and platinum-based chemotherapy. The main goal of this study was to see if gimistotug could increase participant response to treatment, also called the overall response rate.

Only a portion of patients with advanced solid tumors have a durable response to currently available treatments. This represents an unmet medical need to develop improved therapeutic options. Combining immunotherapies with agents having different mechanism of action might improve outcomes for these patients.

This study was designed as a proof of concept to show that gimistotug-based combination treatment may be able to improve responses and clinical benefit in patients with NSCLC. Treatments in all cohorts was administered up to 36 cycles (approximately 2 years) until participants experienced no benefits, too many side effects, or withdrew consent.

Being tested
Gimistotug, Docetaxel, BGB-15025
Keywords
PD-L1, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GimistotugDrug

    Also called BGB-A445

    Administered intravenously

  • DocetaxelDrug

    75 milligrams per square meter (mg/m^2) administered intravenously

  • BGB-15025Drug

    Administered orally

Study groups in NCT06029127
Study groupRoleWhat they receive
Gimistotug + DocetaxelExperimentalParticipants 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.
Receives: Drug: Gimistotug; Drug: Docetaxel
Gimistotug + BGB-15025ExperimentalParticipants 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.
Receives: Drug: Gimistotug; Drug: BGB-15025

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not.

    An SAE is any untoward medical occurrence that, at any dose, meet any of the following criteria:

    • Results in death
    • Is life-threatening
    • Requires hospitalization or prolongation of existing hospitalization
    • Results in disability/incapacity
    • Is a congenital anomaly/birth defect
    • Is considered a significant medical AE by the investigator or the sponsor based on medical judgement

    Measured: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months

  2. Duration of Response (DOR)

    DOR is defined as the time from the first determination of an objective response as assessed by the investigator per RECIST v1 until the first documentation of progression or death, whichever comes first. Median DOR was estimated using the Kaplan-Meier method.

    Measured: From first dose to the end of study; maximum time on follow-up was up to 13.5 months.

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with BOR of a CR, PR, or stable disease.

    Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, with no new lesions.

    Measured: From first dose to the end of study; maximum time on follow-up was up to 13.5 months

  4. Clinical Benefit Rate (CBR)

    CBR is defined as the percentage of participants with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks.

    Measured: 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

  5. Serum Concentrations of Gimistotug

    Measured: 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)

  6. Plasma Concentrations of BGB-15025

    Measured: Cycle 1 Day 1 2 hours and 4-6 hours post-dose, Cycle 1 Day 8 pre-dose, Cycle 1 Day 15 pre-dose, Cycle 2 Day 1 pre-dose and 2 hours and 4-6 hours post-dose, Cycle 3 Day 1 pre-dose

  7. Number of Participants With Anti-Drug Antibodies to Gimistotug

    Measured: Up to 30 days following last dose. Maximum time on treatment was 11.2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start23 Oct 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029127
Sponsor's protocol ID
BGB-LC-203
Other IDs
CTR20233070
Status last verified
Dec 2025
First submitted
24 Aug 2023
Last updated
5 Jan 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gimistotug, Docetaxel and BGB-15025 in people with Non-Small Cell Lung Cancer, run by BeiGene at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06029127.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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