A Study of 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: Docetaxel; Drug: BGB-A445; Drug: Ramucirumab; 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 is to evaluate the anti-tumor activity of BGB-A445 plus investigational agents in participants with non-small cell lung cancer (NSCLC)

Full 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 and platinum-based chemotherapy. 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 immunotherapies with agents having different mechanism of action 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 in all cohorts will be administered up to 36 cycles (approximately 2 years) until participants experience no benefits, too many side effects, or withdraw 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 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 4 patient groups

Stage 1: BGB-A445 + Docetaxel

Experimental group

Description:

BGB-A445 + Docetaxel

Treatment:

Drug: BGB-A445

Drug: Docetaxel

Stage 1: BGB-A445 + BGB-15025

Experimental group

Description:

BGB-A445 + BGB-15025

Treatment:

Drug: BGB-15025

Drug: BGB-A445

Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1

Experimental group

Description:

BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel or BGB-15025)

Treatment:

Drug: BGB-15025

Drug: BGB-A445

Drug: Docetaxel

Docetaxel + Ramucirumab

Other group

Description:

Reference to Stage 2: Ramucirumab + Docetaxel

Treatment:

Drug: Ramucirumab

Drug: Docetaxel