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Completed

NCT Number: NCT06029127

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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

  • 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

Treatment and study plan

Gimistotug

Drug

Administered intravenously

Other names: BGB-A445

docetaxel

Drug

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

BGB-15025

Drug

Administered orally

Primary outcomes

  1. 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

    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 outcomes

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

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

    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

  2. Duration of Response (DOR)

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

    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.

  3. Disease Control Rate (DCR)

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

    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.

  4. Clinical Benefit Rate (CBR)

    Time frame: 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

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

  5. Serum Concentrations of Gimistotug

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2023
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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