Trial Outcomes & Findings for A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (NCT NCT06029127)

Last Updated: 2026-01-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

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

Results posted on

2026-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Gimistotug + Docetaxel Participants 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 Participants 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.
Overall Study STARTED	21	14
Overall Study Received Study Drug	21	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	21	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Gimistotug + Docetaxel Participants 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 Participants 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.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	0
Overall Study Study Closed by Sponsor	6	6
Overall Study Death	12	7
Overall Study Declined Follow-Up Contact	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=9667 Participants	10 Participants n=6597 Participants	20 Participants n=16264 Participants
Age, Categorical >=65 years	11 Participants n=9667 Participants	4 Participants n=6597 Participants	15 Participants n=16264 Participants
Age, Continuous	62.48 years STANDARD_DEVIATION 8.892 • n=9667 Participants	61.36 years STANDARD_DEVIATION 9.532 • n=6597 Participants	62.03 years STANDARD_DEVIATION 9.031 • n=16264 Participants
Sex: Female, Male Female	5 Participants n=9667 Participants	2 Participants n=6597 Participants	7 Participants n=16264 Participants
Sex: Female, Male Male	16 Participants n=9667 Participants	12 Participants n=6597 Participants	28 Participants n=16264 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=9667 Participants	14 Participants n=6597 Participants	35 Participants n=16264 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) Asian	21 Participants n=9667 Participants	14 Participants n=6597 Participants	35 Participants n=16264 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) White	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) More than one race	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9667 Participants	0 Participants n=6597 Participants	0 Participants n=16264 Participants
Region of Enrollment China	21 participants n=9667 Participants	14 participants n=6597 Participants	35 participants n=16264 Participants

PRIMARY outcome

Timeframe: 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

Population: The Intent-to-Treat population included all participants who were enrolled or randomized to a treatment cohort.

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.
Overall Response Rate	0.0 percentage of participants Interval 0.0 to 16.1	0.0 percentage of participants Interval 0.0 to 23.2

SECONDARY outcome

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

Population: The Safety Analysis Set included all participants who were enrolled or randomized and received any dose of any study drug.

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

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of Participants Experiencing TEAEs	20 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of Participants Experiencing SAEs	8 Participants	1 Participants

SECONDARY outcome

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

Population: The Intent-to-Treat Analysis Set included all participants who were enrolled or randomized to a treatment cohort. Only responders were included in the analysis. No participants had a confirmed CR or PR.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: The Intent-to-Treat Analysis Set included all participants who were enrolled or randomized to a treatment cohort.

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.

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.
Disease Control Rate (DCR)	71.4 percentage of participants Interval 47.8 to 88.7	21.4 percentage of participants Interval 4.7 to 50.8

SECONDARY outcome

Timeframe: 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

Population: The Intent-to-Treat Analysis Set included all participants who were enrolled or randomized to a treatment cohort.

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

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.
Clinical Benefit Rate (CBR)	19.0 percentage of participants Interval 5.4 to 41.9	0.0 percentage of participants Interval 0.0 to 23.2

SECONDARY outcome

Timeframe: 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)

Population: The Pharmacokinetic Analysis Set included all participants who received any dose of study drug and for whom the valid study drug pharmacokinetic parameters could be estimated. Results included participants with data available at each time point.

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=21 Participants Participants 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 n=14 Participants Participants 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.
Serum Concentrations of Gimistotug Cycle 1 Day 1 Postdose 0.5 Hours	737.95 µg/mL Geometric Coefficient of Variation 54	846.58 µg/mL Geometric Coefficient of Variation 18
Serum Concentrations of Gimistotug Cycle 5 Day 1 Predose	163.77 µg/mL Geometric Coefficient of Variation 113	222.92 µg/mL Geometric Coefficient of Variation 4
Serum Concentrations of Gimistotug Cycle 5 Day 1 Postdose 0.5 Hours	1027.57 µg/mL Geometric Coefficient of Variation 45	935.41 µg/mL Geometric Coefficient of Variation 9
Serum Concentrations of Gimistotug Cycle 9 Day 1 Predose	244.00 µg/mL	—
Serum Concentrations of Gimistotug End of Treatment Visit	109.90 µg/mL Geometric Coefficient of Variation 106	176.79 µg/mL Geometric Coefficient of Variation 23
Serum Concentrations of Gimistotug Cycle 2 Day 1 Predose	99.84 µg/mL Geometric Coefficient of Variation 57	105.90 µg/mL Geometric Coefficient of Variation 100

SECONDARY outcome

Timeframe: 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

Population: The Pharmacokinetic Analysis Set included all participants who received any dose of study drug and for whom the valid pharmacokinetic parameters can be estimated.

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=14 Participants Participants 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 Participants 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.
Plasma Concentrations of BGB-15025 Cycle 1 Day 1 Postdose 2 Hours	0.36 µg/mL Geometric Coefficient of Variation 214	—
Plasma Concentrations of BGB-15025 Cycle 1 Day 1 Postdose 4-6 Hours	0.49 µg/mL Geometric Coefficient of Variation 47	—
Plasma Concentrations of BGB-15025 Cycle 1 Day 8 Predose	0.29 µg/mL Geometric Coefficient of Variation 50	—
Plasma Concentrations of BGB-15025 Cycle 1 Day 15 Predose	0.25 µg/mL Geometric Coefficient of Variation 61	—
Plasma Concentrations of BGB-15025 Cycle 2 Day 1 Predose	0.18 µg/mL Geometric Coefficient of Variation 132	—
Plasma Concentrations of BGB-15025 Cycle 2 Day 1 Postdose 2 Hours	0.47 µg/mL Geometric Coefficient of Variation 38	—
Plasma Concentrations of BGB-15025 Cycle 2 Day 1 Postdose 4-6 Hours	0.59 µg/mL Geometric Coefficient of Variation 30	—
Plasma Concentrations of BGB-15025 Cycle 3 Day 1 Predose	0.30 µg/mL Geometric Coefficient of Variation 27	—

SECONDARY outcome

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

Population: The Anti-Drug Antibody Analysis Set included all participants who received the study drug and in whom both baseline anti-drug antibody and at least one postbaseline anti-drug antibody results are available.

Outcome measures

Outcome measures
Measure	Gimistotug + Docetaxel n=18 Participants Participants 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 n=13 Participants Participants 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.
Number of Participants With Anti-Drug Antibodies to Gimistotug	2 Participants	2 Participants

Adverse Events

Gimistotug + Docetaxel

Serious events: 8 serious events

Other events: 20 other events

Deaths: 12 deaths

Gimistotug + BGB-15025

Serious events: 1 serious events

Other events: 12 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Gimistotug + Docetaxel n=21 participants at risk Participants 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 n=14 participants at risk Participants 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.
Blood and lymphatic system disorders Anaemia	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Blood and lymphatic system disorders Febrile neutropenia	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Blood and lymphatic system disorders Leukopenia	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Blood and lymphatic system disorders Myelosuppression	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Infections and infestations Diverticulitis	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Infections and infestations Pneumonia	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	7.1% 1/14 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Infections and infestations Pneumonia bacterial	0.00% 0/21 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	7.1% 1/14 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Injury, poisoning and procedural complications Thermal burn	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Investigations Neutrophil count decreased	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months
Investigations Platelet count decreased	4.8% 1/21 • Number of events 1 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months	0.00% 0/14 • All-Cause Mortality: Up to 13.5 months AEs: From first dose of study drug to 30 days after last dose. Maximum time on treatment was 11.2 months

Other adverse events

Additional Information

Study Director

BeiGene

Phone: 1 877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER