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A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
BGB-A445
LBL-007
Carboplatin
Cisplatin
pemetrexed
Paclitaxel
Nab paclitaxel
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, NSCLC, programmed cell death protein-1, PD-L1 Low Tumors, PD-L1 Negative Tumors, Metastatic Non-Small Cell Lung Cancer, PD-L1 High Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study. At least 1 measurable lesion as defined per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: Has mixed small cell lung cancer. Participants with known actionable mutations for which a targeted therapy has been approved by the local health authority will be excluded. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases. NOTE: Other protocol and sub-study protocol defined criteria may apply

Sites / Locations

  • California Cancer Associates For Research and Excellence, Ccare EncinitasRecruiting
  • Valkyrie Clinical TrialsRecruiting
  • Memorial Sloan Kettering Cancer Center MskccRecruiting
  • Blacktown Cancer and Haematology CentreRecruiting
  • Chris Obrien LifehouseRecruiting
  • Northern Beaches HospitalRecruiting
  • Port Macquarie Base HospitalRecruiting
  • One Clinical ResearchRecruiting
  • St John of God Health CareRecruiting
  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Fujian Cancer HospitalRecruiting
  • Affiliated Hospital of Hebei UniversityRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Hubei Cancer HospitalRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • The First Affiliated Hospital of Nanchang University Branch XianghuRecruiting
  • Jining No Peoples HospitalRecruiting
  • Linyi Peoples HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • Tianjin Medical University Cancer Institute and HospitalRecruiting
  • Taizhou Hospital of ZhejiangRecruiting
  • Chungbuk National University HospitalRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • The Institute of Oncology, Arensia Exploratory MedicineRecruiting
  • National Cancer Centre SingaporeRecruiting
  • Srinagarind Hospital (Khon Kaen University)Recruiting
  • Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Sub-study 1: Experimental Arm 1A

Sub-study 1: Experimental Arm 2A

Sub-study 1: Reference Arm

Sub-study 2 : Experimental Arm 1A

Sub-study 2: Experimental Arm 1B

Sub-study 2: Reference Arm

Arm Description

Tislelizumab + BGB-A445

Tislelizumab + LBL-007

Tislelizumab alone

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007

Tislelizumab + investigator's choice of histology-appropriate chemotherapy

Outcomes

Primary Outcome Measures

Confirmed overall response rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

Secondary Outcome Measures

Progression-free survival (PFS)
PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Plasma or serum concentrations of tislelizumab
Plasma or serum concentrations of BGB-A445
Plasma or serum concentrations of LBL-007
Number of participants with anti-drug antibodies (ADAs) to tislelizumab
Number of participants with anti-drug antibodies (ADAs) to LBL-007
Number of participants with anti-drug antibodies (ADAs) to BGB-A445

Full Information

First Posted
November 23, 2022
Last Updated
September 20, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT05635708
Brief Title
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Official Title
Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer, NSCLC, programmed cell death protein-1, PD-L1 Low Tumors, PD-L1 Negative Tumors, Metastatic Non-Small Cell Lung Cancer, PD-L1 High Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub-study 1: Experimental Arm 1A
Arm Type
Experimental
Arm Description
Tislelizumab + BGB-A445
Arm Title
Sub-study 1: Experimental Arm 2A
Arm Type
Experimental
Arm Description
Tislelizumab + LBL-007
Arm Title
Sub-study 1: Reference Arm
Arm Type
Experimental
Arm Description
Tislelizumab alone
Arm Title
Sub-study 2 : Experimental Arm 1A
Arm Type
Experimental
Arm Description
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445
Arm Title
Sub-study 2: Experimental Arm 1B
Arm Type
Experimental
Arm Description
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007
Arm Title
Sub-study 2: Reference Arm
Arm Type
Active Comparator
Arm Description
Tislelizumab + investigator's choice of histology-appropriate chemotherapy
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
BGB-A445
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
Administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Investigator's choice; administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Investigator's choice; administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
Investigator's choice; administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Investigator's choice; administered by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
Investigator's choice; administered by intravenous infusion
Primary Outcome Measure Information:
Title
Confirmed overall response rate (ORR)
Description
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Time Frame
Up to 3 Years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.
Time Frame
Up to 3 Years
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator
Time Frame
Up to 3 Years
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1
Time Frame
Up to 3 Years
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Time Frame
Up to 3 Years
Title
Number of participants with adverse events (AEs)
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Time Frame
Up to 3 Years
Title
Plasma or serum concentrations of tislelizumab
Time Frame
Up to 30 days after last dose
Title
Plasma or serum concentrations of BGB-A445
Time Frame
Up to 30 days after last dose
Title
Plasma or serum concentrations of LBL-007
Time Frame
Up to 30 days after last dose
Title
Number of participants with anti-drug antibodies (ADAs) to tislelizumab
Time Frame
Up to 30 days after last dose
Title
Number of participants with anti-drug antibodies (ADAs) to LBL-007
Time Frame
Up to 30 days after last dose
Title
Number of participants with anti-drug antibodies (ADAs) to BGB-A445
Time Frame
Up to 30 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study. At least 1 measurable lesion as defined per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: Has mixed small cell lung cancer. Participants with known actionable mutations for which a targeted therapy has been approved by the local health authority will be excluded. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases. NOTE: Other protocol and sub-study protocol defined criteria may apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BeiGene
Phone
+1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Associates For Research and Excellence, Ccare Encinitas
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Name
Valkyrie Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center Mskcc
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Blacktown Cancer and Haematology Centre
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Name
Chris Obrien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Name
Northern Beaches Hospital
City
Frenchs Forest
State/Province
New South Wales
ZIP/Postal Code
2086
Country
Australia
Individual Site Status
Recruiting
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Individual Site Status
Recruiting
Facility Name
One Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
St John of God Health Care
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University Branch Xianghu
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Name
Jining No Peoples Hospital
City
Jining
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Name
Linyi Peoples Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Taizhou Hospital of Zhejiang
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongjusi
State/Province
Chungcheongbukdo
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyangsi
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnamsi
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Institute of Oncology, Arensia Exploratory Medicine
City
Chisinau
ZIP/Postal Code
2025
Country
Moldova, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Srinagarind Hospital (Khon Kaen University)
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
City
Ongkharak
ZIP/Postal Code
26120
Country
Thailand
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

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