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Gimistotug

Phase 2

Non-Small Cell Lung Cancer | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Jan 5, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Gimistotug · 1 trial · 1 indication

Phase 2 1
NCT06029127A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung CancerNon-Small Cell Lung Cancer
COMPLETED35 Analytics
PHASE2COMPLETED
A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Response Rate
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

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.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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.
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.

Interventions

NameTypeDescription
GimistotugDRUGAdministered intravenously
DocetaxelDRUG75 milligrams per square meter (mg/m\^2) administered intravenously
BGB-15025DRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * 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 an...

Countries:ChinaSouth Korea
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about Gimistotug

What is Gimistotug used for?

Gimistotug is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer (NSCLC). It is currently in Phase 2 clinical development and has been evaluated in a completed clinical trial involving 35 participants.

Who makes Gimistotug?

Gimistotug is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol ONC. The company is conducting clinical research on this investigational drug for Non-Small Cell Lung Cancer.

What phase is Gimistotug in?

Gimistotug is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy for treating Non-Small Cell Lung Cancer.

What clinical trials is Gimistotug in?

Gimistotug has been studied in a Phase 2 clinical trial registered as NCT06029127, titled 'A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer.' This trial was completed and enrolled 35 participants in China and South Korea.

Is Gimistotug the same as BGB-A445?

Yes, Gimistotug is also known as BGB-A445. The clinical trial NCT06029127 refers to the drug as Gimistotug (BGB-A445), indicating that these names are used interchangeably for the same investigational drug being developed for Non-Small Cell Lung Cancer.