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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

NCT06091943

CompletedPhase 1

Sponsor: BeiGene

Conditions: Non-small Cell Lung Cancer

Interventions: Tislelizumab IV, Tislelizumab SC, Histology-Based Chemotherapy Doublet

Countries: China, Georgia, Moldova

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (15)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Zhengzhou, Henan, China
Nanchang, Jiangxi, China
Jinan, Shandong, China
Jining, Shandong, China
Taiyuan, Shanxi, China
Taiyuan, Shanxi, China
Deyang, Sichuan, China
Huzhou, Zhejiang, China
Tbilisi, Georgia
Chisinau, Moldova