Clinical trial NCT06029127: A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: PD-L1
NSCLC
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to Approximately 3 years
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Approximately 3 years
measure: Duration of Response (DOR)
timeFrame: Up to Approximately 3 years
measure: Disease Control Rate (DCR)
timeFrame: Up to Approximately 3 years
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to Approximately 3 years
measure: Progression Free Survival (PFS)
timeFrame: Up to Approximately 3 years
measure: Overall Survival (OS)
timeFrame: Up to Approximately 3 years
measure: Plasma and Serum Concentrations of BGB-A445 and Investigational Agents
timeFrame: 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)
measure: Number of participants with Anti-Drug Antibodies to BGB-A445 and Investigational Agents
timeFrame: Up to Approximately 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University South Campus
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Taian
country: China
facility: The Second Affiliated Hospital of Shandong First Medical University
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Suwonsi
country: Korea, Republic of
facility: The Catholic University of Korea, St Vincents Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: