Trial Title:
Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer
NCT ID:
NCT05577702
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Pemetrexed
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered as an intravenous infusion
Arm group label:
Arm 1A: Tislelizumab Monotherapy
Arm group label:
Arm 1B: Tislelizumab and Ociperlimab
Arm group label:
Arm 1C: Tislelizumab and LBL-007
Arm group label:
Arm 2A: Tislelizumab and Chemotherapy
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
Other name:
BGB-A317
Other name:
Tevimbra
Intervention type:
Drug
Intervention name:
Ociperlimab
Description:
Administered as an intravenous infusion
Arm group label:
Arm 1B: Tislelizumab and Ociperlimab
Other name:
BGB-A1217
Intervention type:
Drug
Intervention name:
LBL-007
Description:
Administered as an intravenous infusion
Arm group label:
Arm 1C: Tislelizumab and LBL-007
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Administered as an intravenous infusion
Arm group label:
Arm 2A: Tislelizumab and Chemotherapy
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered as an intravenous infusion
Arm group label:
Arm 2A: Tislelizumab and Chemotherapy
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered as an intravenous infusion
Arm group label:
Arm 2A: Tislelizumab and Chemotherapy
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered as an intravenous infusion
Arm group label:
Arm 2A: Tislelizumab and Chemotherapy
Arm group label:
Arm 2C: LBL-007 and Tislelizumab and Chemotherapy
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.
Criteria for 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)
- 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 15 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)
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell
immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3),
or any other antibody or drug specifically targeting T-cell costimulation or
checkpoint pathways
- Has mixed small cell lung cancer
- Participants with large cell neuroendocrine carcinoma (LCNEC)
- The presence of locally advanced unresectable NSCLC regardless of stage or
metastatic disease
- Known EGFR sensitizing mutations and/or ALK rearrangement
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Wannan Medical College
Address:
City:
Wuhu
Zip:
241001
Country:
China
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
Address:
City:
Guangzhou
Zip:
510140
Country:
China
Facility:
Name:
The Tumor Hospital Affiliated to Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Zip:
455001
Country:
China
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University Branch Xianghu
Address:
City:
Nanchang
Zip:
332000
Country:
China
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Start date:
February 16, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577702
