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

BeiGene

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Gimistotug; Drug: Docetaxel; Drug: BGB-15025

Study type: Interventional

Funder types: Industry

Identifiers

NCT06029127

BGB-LC-203

CTR20233070 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Gimistotug + Docetaxel

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel

Drug: Gimistotug

Gimistotug + BGB-15025

Experimental group

Description:

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.

Treatment:

Drug: BGB-15025

Drug: Gimistotug