Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Nonsmall Cell Lung Cancer, Stage IV Clinical Trial

Official title:

AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05014815
• Other study ID #: AdvanTIG-205
• Secondary ID: 2021-001075-17
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized investigator and patient blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 272
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.

2. No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Patients who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of = 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.

3. Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only patients who have evaluable PD-L1 results are eligible.

4. At least one measurable lesion by the investigator per RECIST v1.1. .

5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.

Key Exclusion Criteria:

1. Known mutations in:

• EGFR gene Note: For non-squamous NSCLC, patients with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Patients found to have EGFR-sensitizing mutations will be excluded.
• ALK fusion oncogene.
• BRAF V600E
• ROS1

2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.

3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.

4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before randomization.

5. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsmall Cell Lung Cancer, Stage IV

Intervention

Drug:
• Ociperlimab
Ociperlimab intravenous injection
• Tislelizumab
Tislelizumab intravenous injection
• histology-based chemotherapy
Administered intravenously
• Placebo
Administered as an intravenous injection

Locations

Country	Name	City	State
Australia	Townsville University Hospital	Douglas	Queensland
Australia	Peninsula & South Eastern Hematology and Oncology Group	Frankston	Victoria
Australia	Northern Beaches Hospital	Frenchs Forest	New South Wales
Australia	Olivia Newton-John Cancer Wellness & Research Centre	Heidelberg	Victoria
Australia	Port Macquarie Base Hospital	Port Macquarie,	New South Wales
Australia	Toowoomba Hospital	Toowoomba	Queensland
Austria	Universitätsklinikum Krems	Krems	Krems An Der Donau
China	Ansteel Group General Hospital	Anshan	Liaoning
China	Beijing Cancer Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Changzhou Cancer Hospital	Changzhou	Jiangsu
China	West China Hospital ,Sichuan University	Chengdu	Sichuan
China	Chenzhou First People's Hospital	Chenzhou	Hunan
China	Army Medical Center of PLA	Chongqing	Chongqing
China	Xin Qiao Hospital Affiliated to The Army Medical University	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fujian	Fujian
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Affiliated Tumor Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	The First People's Hospital of Kashgar	Kashgar	Xinjiang
China	First Hospital of Lanzhou University	Lanzhou	Gansu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Fudan university Shanghai Cancer Center	Shanghai	Shanghai
China	Huashan hospital affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	First Affiliated Hospital, School of Medicine, Shihezi University	Shihezi	Xinjiang
China	Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
France	Hôpital Européen Georges Pompidou	Paris	Cedex
France	Institut Curie	Paris
France	Hopital Charles Nicolle - Centre Hospitalier Universitaire de Rouen	Rouen	Cedex
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center, CHA University	Gyeonggi-do
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul	Gangnam-Gu
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Spain	Centro Oncológico de Galicia	A Coruña
Spain	Consorcio Hospitalario Provincial de Castellón	Castillón	Comunidad De Valencia
Spain	Hospital Universitario de León	León	Leon
Spain	MD Anderson Cancer Center - Madrid	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Austrias
Spain	Instituto Valenciano de Oncologia-IVO	Valencia	Comunidad De Valencia
United States	Xcancer_Dayton Physician Network	Dayton	Ohio
United States	Comprehensive Cancer Center of Nevada	Henderson	Nevada
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Tennessee Cancer Specialist	Knoxville	Tennessee
United States	Northwell Health-Monter Cancer Center	Lake Success	New York
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Texas Oncology (Tyler) - USOR	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  China,  France,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) as Assessed by Investigators	PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first	Up to approximately 30 months
Secondary	Overall Response Rate (ORR) as Assessed by Investigators	ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.	Up to approximately 30 months
Secondary	Duration of Response (DoR) As Assessed by Investigators	DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first	Up to approximately 30 months
Secondary	Overall Survival (OS)	OS will be defined as the time from the date of randomization to the date of death due to any cause.	Up to approximately 30 months
Secondary	Number of Participants Experiencing Adverse Events (AEs)	The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).	90 days (±14) after last dose
Secondary	Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints		Up to approximately 12 months or end of treatment visit
Secondary	Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs).		Up to approximately 12 months or end of treatment visit