Trial Title:
Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT06091943
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Conditions: Keywords:
lung cancer
non-small cell lung cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab IV
Description:
Planned doses will be administered intravenously.
Arm group label:
Part 1: Dose/Injection Site Exploration
Other name:
BGB-A317 IV
Intervention type:
Drug
Intervention name:
Tislelizumab SC
Description:
Planned doses will be administered via subcutaneous injection.
Arm group label:
Part 1: Dose/Injection Site Exploration
Arm group label:
Part 2: Dose Expansion
Other name:
BGB-A317 SC
Intervention type:
Drug
Intervention name:
Histology-Based Chemotherapy Doublet
Description:
Chemotherapy Doublet 1: Cisplatin/carboplatin + pemetrexed.
Chemotherapy Doublet 2: Carboplatin + paclitaxel/nab-paclitaxel.
Choice of histology-based induction chemotherapy doublet will be determined by the
investigator and will be administered at standard doses intravenously.
Arm group label:
Part 1: Dose/Injection Site Exploration
Arm group label:
Part 2: Dose Expansion
Summary:
This is an open-label, multicenter, Phase 1 clinical study to evaluate the
bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment
of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This
clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and
dose expansion (Part 2).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Able to sign a written consent form, understand, and agree to comply with
requirements of the study.
- 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.
- No prior systemic treatment for advanced or metastatic NSCLC, including but not
limited to chemotherapy or targeted therapy.
- At least one measurable lesion as assessed by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) PS ≤ 1.
- Adequate organ function as indicated by laboratory tests.
Exclusion Criteria:
- Participants diagnosed with NSCLC that harbor a driver mutation (eg,
EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1
mutation).
- Participant has received any Chinese herbal medicine or Chinese patent medicines
used to control cancer within 14 days before first dose of study drug.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Any cancer ≤ 5 years before first dose of study drug except for the specific cancer
under investigation in this study and any locally recurring cancer that has been
treated curatively (eg, resected basal or squamous cell skin cancer, superficial
bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or
breast).
- Any condition that required systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days
before first dose of study drug.
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:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Facility:
Name:
Mengchao Hepatobiliary Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350025
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University Branch Donghu
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Facility:
Name:
Jining No Peoples Hospital East Branch
Address:
City:
Jining
Zip:
272002
Country:
China
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030032
Country:
China
Facility:
Name:
Deyangs People Hospital
Address:
City:
Deyang
Zip:
618000
Country:
China
Facility:
Name:
Huzhou Central Hospital
Address:
City:
Huzhou
Zip:
313003
Country:
China
Facility:
Name:
Arensia Exploratory Medicine Llc
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Facility:
Name:
The Institute of Oncology, Arensia Exploratory Medicine
Address:
City:
Chisinau
Zip:
2025
Country:
Moldova, Republic of
Start date:
November 16, 2023
Completion date:
March 31, 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/NCT06091943
