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

Sponsor

BeiGene (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06029127

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The main objective of this study is to evaluate the anti-tumor activity of BGB-A445 plus investigational agents in participants with non-small cell lung cancer (NSCLC)

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: BGB-A445 Drug: Docetaxel Drug: Tislelizumab Drug: Sitravatinib Drug: Ramucirumab Drug: Selected Interventions Drug: BGB-15025	Phase 2

Detailed Description

This study will test whether BGB-A445 in combination with other agents can 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. The main goal of this study is to see if BGB-A445 can 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 targeted vascular therapies with immunotherapies might improve outcomes for these patients.

This study is designed as a proof of concept to show that BGB-A445-based combination treatment may be able to improve responses and clinical benefit in patients with NSCLC. Stage 1 of the study will take place in China and the Asia Pacific region and Stage 2 will be expanded to take place worldwide. The overall time to participate in this study is approximately 3 years. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stage 1: BGB-A445 + Docetaxel BGB-A445 + Docetaxel	Drug: BGB-A445 Administered intravenously at protocol defined dose Drug: Docetaxel 75 milligrams per square meter (mg/m^2) administered intravenously
Experimental: Stage 1: BGB-A445 + Tislelizumab + Sitravatinib BGB-A445 + tislelizumab + Sitravatinib	Drug: BGB-A445 Administered intravenously at protocol defined dose Drug: Tislelizumab Administered intravenously at protocol defined dose Other Names: BGB-A317 Drug: Sitravatinib Administered orally at protocol defined dose
Experimental: Stage 1: BGB-A445 + BGB-15025 BGB-A445 + BGB-15025	Drug: BGB-A445 Administered intravenously at protocol defined dose Drug: BGB-15025 Administered orally at protocol defined dose
Experimental: Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1 BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel, Tislelizumab + Sitravatinib or BGB-15025)	Drug: BGB-A445 Administered intravenously at protocol defined dose Drug: Docetaxel 75 milligrams per square meter (mg/m^2) administered intravenously Drug: Tislelizumab Administered intravenously at protocol defined dose Other Names: BGB-A317 Drug: Sitravatinib Administered orally at protocol defined dose Drug: Selected Interventions Administered at protocol defined dose Drug: BGB-15025 Administered orally at protocol defined dose
Other: Docetaxel + Ramucirumab Reference to Stage 2: Ramucirumab + Docetaxel	Drug: Docetaxel 75 milligrams per square meter (mg/m^2) administered intravenously Drug: Ramucirumab 10 mg/kg administered intravenously

Outcome Measures

Primary Outcome Measures

Overall Response Rate [Up to Approximately 3 years]
Overall response rate (ORR) is defined as the percentage of participants with best overall response (BOR) of a complete response (CR) or partial response (PRas assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1. ).

Secondary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to Approximately 3 years]
Duration of Response (DOR) [Up to Approximately 3 years]
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
Disease Control Rate (DCR) [Up to Approximately 3 years]
DCR is defined as the percentage of participants with BOR of a CR, PR, or stable disease.
Clinical Benefit Rate (CBR) [Up to Approximately 3 years]
CBR is defined as the percentage of participants with BOR of a CR, PR, or stable disease lasting ≥ 24 weeks
Progression Free Survival (PFS) [Up to Approximately 3 years]
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first
Overall Survival (OS) [Up to Approximately 3 years]
OS is defined as the time from the date of randomization to the date of death due to any cause
Plasma and Serum Concentrations of BGB-A445 and Investigational Agents [Days 1, 8, and 15 of Cycle 1 and days 1 and 8 of Cycle 2, and Day 1 of all subsequent Cycles and End of Study Visit - Up to approximately 3 years (each cycle 21 days)]
Number of participants with Ant-Drug Antibodies to BGB-A445 and Investigational Agents [Up to Approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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-L1) anti-PD-(L)1 treatment
At least 1 measurable lesion as defined per 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