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
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
62 participants
INTERVENTIONAL
2023-11-16
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose/Injection Site Exploration
Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.
Tislelizumab IV
Planned doses will be administered intravenously.
Tislelizumab SC
Planned doses will be administered via subcutaneous injection.
Histology-Based Chemotherapy Doublet
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.
Part 2: Dose Expansion
The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.
Tislelizumab SC
Planned doses will be administered via subcutaneous injection.
Histology-Based Chemotherapy Doublet
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.
Interventions
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Tislelizumab IV
Planned doses will be administered intravenously.
Tislelizumab SC
Planned doses will be administered via subcutaneous injection.
Histology-Based Chemotherapy Doublet
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No Peoples Hospital East Branch
Jining, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Deyangs People Hospital
Deyang, Sichuan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Arensia Exploratory Medicine Llc
Tbilisi, , Georgia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, , Moldova
Countries
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Other Identifiers
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CTR20233814
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-103
Identifier Type: -
Identifier Source: org_study_id
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