Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
BeiGene
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 meta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06091943
Start Date
November 16 2023
End Date
July 31 2026
Last Update
August 12 2025
Active Locations (15)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014