Back to resultsEfficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Ociperlimab
LBL-007
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
Participant must have tumor PD-L1 expression ≥ 1% determined by a local laboratory with an approved assay
- Tumor PD-L1 expression ≥ 50% for participants enrolled for Arm A, Arm B, and Arm C in Stage 1
- Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
- Provide formalin-fixed paraffin-embedded block containing approximately one core needle of biopsy sample of the primary tumor for biomarker evaluation during screening to the central laboratory
Exclusion Criteria:
- Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
- Participants with large cell neuroendocrine carcinoma (LCNEC)
- The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease (Stage IV). Mediastinal lymph node samples are required for clinical staging to assess nodal involvement in participants with contralateral mediastinal adenopathy on CT scan
- History of interstitial lung disease, pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection
- Known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROS1 mutations)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- The First Affiliated Hospital of Wannan Medical CollegeRecruiting
- Beijing Cancer HospitalRecruiting
- Fujian Medical University Union HospitalRecruiting
- The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- The Tumor Hospital Affiliated to Guangxi Medical UniversityRecruiting
- Anyang Cancer HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- Hunan Cancer HospitalRecruiting
- The First Affiliated Hospital of Nanchang University Branch XianghuRecruiting
- Liaoning Cancer Hospital and InstituteRecruiting
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Shanghai Pulmonary HospitalRecruiting
- Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm A: Tislelizumab Monotherapy
Arm B: Tislelizumab and Ociperlimab
Arm C: Tislelizumab and LBL-007
Arm Description
Tislelizumab on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Tislelizumab + ociperlimab on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Tislelizumab + LBL-007 on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Outcomes
Primary Outcome Measures
Major Pathological Response (MPR)
MPR is defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR)
Secondary Outcome Measures
Pathological complete response (pCR)
pCR is defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR
Event-free survival (EFS)
EFS is defined as the time from randomization until any of the following events, whichever occurs first: radiographic disease progression that precludes definitive surgery, local or distant recurrence, as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause
Disease-free survival (DFS)
DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first
Number of participants with adverse events
Number of participants with treatment-emergent adverse events, including serious adverse events and immune-mediated adverse events (imAEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Proportion of participants who undergo surgical resection
Proportion of participants who undergo surgical resection within a scheduled period after receiving any dose of investigational agents, delayed or canceled surgery, duration of surgery and surgical approach
Serum or plasma concentrations of investigational agents
Number of participants with anti-drug antibodies (ADAs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05577702
Brief Title
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
Official Title
A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2026 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Tislelizumab Monotherapy
Arm Type
Experimental
Arm Description
Tislelizumab on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Arm Title
Arm B: Tislelizumab and Ociperlimab
Arm Type
Experimental
Arm Description
Tislelizumab + ociperlimab on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Arm Title
Arm C: Tislelizumab and LBL-007
Arm Type
Experimental
Arm Description
Tislelizumab + LBL-007 on a 3-week cycle for 2 cycles, followed by surgical resection (each cycle is 21 days)
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
Administered as an intravenous infusion
Intervention Type
Drug
Intervention Name(s)
LBL-007
Intervention Description
Administered as an intravenous infusion
Primary Outcome Measure Information:
Title
Major Pathological Response (MPR)
Description
MPR is defined as the proportion of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR)
Time Frame
Up to approximately 12 weeks after first dose
Secondary Outcome Measure Information:
Title
Pathological complete response (pCR)
Description
pCR is defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes as assessed by the BIPR
Time Frame
Up to approximately 12 weeks after first dose
Title
Event-free survival (EFS)
Description
EFS is defined as the time from randomization until any of the following events, whichever occurs first: radiographic disease progression that precludes definitive surgery, local or distant recurrence, as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause
Time Frame
Up to approximately 4 years
Title
Overall survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death due to any cause
Time Frame
Up to approximately 4 years
Title
Disease-free survival (DFS)
Description
DFS is defined as the time from the first date of no disease (ie, participants who underwent margin-negative [R0] resection) to local or distant recurrence, as assessed by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first
Time Frame
Up to approximately 4 years
Title
Number of participants with adverse events
Description
Number of participants with treatment-emergent adverse events, including serious adverse events and immune-mediated adverse events (imAEs), with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Time Frame
Up to approximately 4 years
Title
Proportion of participants who undergo surgical resection
Description
Proportion of participants who undergo surgical resection within a scheduled period after receiving any dose of investigational agents, delayed or canceled surgery, duration of surgery and surgical approach
Time Frame
Up to approximately 12 weeks after first dose
Title
Serum or plasma concentrations of investigational agents
Time Frame
Up to 30 days after last dose
Title
Number of participants with anti-drug antibodies (ADAs)
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:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer [NSCLC] staging system)
Participant must have tumor PD-L1 expression ≥ 1% determined by a local laboratory with an approved assay
Tumor PD-L1 expression ≥ 50% for participants enrolled for Arm A, Arm B, and Arm C in Stage 1
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
Provide formalin-fixed paraffin-embedded block (preferred) or at least 18 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening
Exclusion Criteria:
Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)
Participants with large cell neuroendocrine carcinoma (LCNEC)
The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease (Stage IV). Mediastinal lymph node samples are required for clinical staging to assess nodal involvement in participants with contralateral mediastinal adenopathy on CT scan
History of interstitial lung disease, pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases
Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection
Known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROS1 mutations)
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
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
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
The Tumor Hospital Affiliated to Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Anyang Cancer Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455001
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
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
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
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
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
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
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