NCT06091943CompletedPhase 1
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
Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 16 Oct 2023
- Start date
- 16 Nov 2023
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- BeiGene
- Diseases
- Lung cancer
- NCT number
- NCT06091943
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 62
- From 16 Nov 2023 to the primary completion date, 31 Jul 2025
- 15 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug.
- 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.
Other illness
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Lab values
- Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation).
Age
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Deyangs People Hospital Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Huzhou Central Hospital Coordinator of this site? Confirm its status | Huzhou | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Jining No Peoples Hospital East Branch Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| The First Affiliated Hospital of Nanchang University Branch Donghu Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Shanxi Provincial Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| ARENSIA Exploratory Medicine LLC Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| The Institute of Oncology, Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
Related publications
- Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer.Clin Transl Sci · 2026 · PMID 42337921
This page is information, not medical advice. Discuss any trial with your doctor.