A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06029127
- Lead Sponsor
- BeiGene
- 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)
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1 BGB-A445 BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel or BGB-15025) Stage 1: BGB-A445 + BGB-15025 BGB-A445 BGB-A445 + BGB-15025 Stage 1: BGB-A445 + BGB-15025 BGB-15025 BGB-A445 + BGB-15025 Stage 1: BGB-A445 + Docetaxel BGB-A445 BGB-A445 + Docetaxel Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1 BGB-15025 BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel or BGB-15025) Docetaxel + Ramucirumab Docetaxel Reference to Stage 2: Ramucirumab + Docetaxel Stage 2: BGB-A445 + selected investigational agent(s) from Stage 1 Docetaxel BGB-A445 + selected investigational agent(s) from Stage 1 (either Docetaxel or BGB-15025) Stage 1: BGB-A445 + Docetaxel Docetaxel BGB-A445 + Docetaxel Docetaxel + Ramucirumab Ramucirumab Reference to Stage 2: Ramucirumab + Docetaxel
- Primary Outcome Measures
Name Time Method 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 (PR) as assessed by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1.
- Secondary Outcome Measures
Name Time Method 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
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) 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.
Number of participants with Anti-Drug Antibodies to BGB-A445 and Investigational Agents Up to Approximately 3 years 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
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
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
Trial Locations
- Locations (18)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Jiangnan University South Campus
🇨🇳Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Shandong First Medical University
🇨🇳Taian, Shandong, China
Weihai Municipal Hospital
🇨🇳Weihai, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
National Cancer Center
🇰🇷Goyangsi, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St Vincents Hospital
🇰🇷Suwonsi, Gyeonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of