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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029127
• Other study ID #: BGB-LC-203
• Secondary ID: CTR20233070
• Status: Recruiting
• Phase: Phase 2
• Start date: October 23, 2023
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• BGB-A445
Administered intravenously at protocol defined dose
• Docetaxel
75 milligrams per square meter (mg/m^2) administered intravenously
• Ramucirumab
10 mg/kg administered intravenously
• BGB-15025
Administered orally at protocol defined dose

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Daping Hospital, Third Military Medical University	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Second Affiliated Hospital of Shandong First Medical University	Taian	Shandong
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Weihai Municipal Hospital	Weihai	Shandong
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University South Campus	Wuxi	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
Korea, Republic of	Chungbuk National University Hospital	Cheongjusi	Chungcheongbukdo
Korea, Republic of	National Cancer Center	Goyangsi	Gyeonggido
Korea, Republic of	Cha Bundang Medical Center, Cha University	Gyeonggido
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	Gyeongsang National University Hospital	Jinjusi	Gyeongsangnamdo
Korea, Republic of	Asan Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, St Vincents Hospital	Suwonsi	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	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.	Up to Approximately 3 years
Secondary	Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to Approximately 3 years
Secondary	Duration of Response (DOR)	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	Up to Approximately 3 years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants with BOR of a CR, PR, or stable disease.	Up to Approximately 3 years
Secondary	Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with BOR of a CR, PR, or stable disease lasting = 24 weeks	Up to Approximately 3 years
Secondary	Progression Free Survival (PFS)	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	Up to Approximately 3 years
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause	Up to Approximately 3 years
Secondary	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)
Secondary	Number of participants with Anti-Drug Antibodies to BGB-A445 and Investigational Agents		Up to Approximately 3 years