Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Deyangs People Hospital
Coordinator of this site? Confirm its status
DeyangChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Huzhou Central Hospital
Coordinator of this site? Confirm its status
HuzhouChinaUnknown status
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Jining No Peoples Hospital East Branch
Coordinator of this site? Confirm its status
JiningChinaUnknown status
The First Affiliated Hospital of Nanchang University Branch Donghu
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Shanxi Bethune Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Shanxi Provincial Cancer Hospital
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
ARENSIA Exploratory Medicine LLC
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
The Institute of Oncology, Arensia Exploratory Medicine
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.