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Non-small Cell Lung CancerPhase 1NCT06091943

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

A Phase 1 study testing Tislelizumab IV, Tislelizumab SC and Histology-Based Chemotherapy Doublet in people with Non-small Cell Lung Cancer, run by BeiGene at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Tislelizumab IV, Tislelizumab SC and Histology-Based Chemotherapy Doublet
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
15 sitesin 3 countries
Study dates
16 Nov 2023to 4 Aug 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

China13 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Deyangs People Hospital

    Deyang, Sichuan, 618000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313003

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jining No Peoples Hospital East Branch

    Jining, Shandong, 272002

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Georgia1 site

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112

Other trials in Georgia

Moldova1 site

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025

Other trials in Moldova

About this study

Official title: 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

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).

Being tested
Tislelizumab IV, Tislelizumab SC, Histology-Based Chemotherapy Doublet
Keywords
lung cancer, non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab IVDrug

    Also called BGB-A317 IV

    Planned doses will be administered intravenously.

  • Tislelizumab SCDrug

    Also called BGB-A317 SC

    Planned doses will be administered via subcutaneous injection.

  • Histology-Based Chemotherapy DoubletDrug

    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.

Study groups in NCT06091943
Study groupRoleWhat they receive
Part 1: Dose/Injection Site ExplorationExperimentalDifferent 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.
Receives: Drug: Tislelizumab IV; Drug: Tislelizumab SC; Drug: Histology-Based Chemotherapy Doublet
Part 2: Dose ExpansionExperimentalThe 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.
Receives: Drug: Tislelizumab SC; Drug: Histology-Based Chemotherapy Doublet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC

    Measured: Up to approximately 3.5 months

  2. Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC

    Measured: Up to approximately 3.5 months

  3. Part 1: Bioavailability of Tislelizumab SC

    Measured: Up to approximately 2 months

  4. Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC

    Measured: Up to approximately 3.5 months

  5. Part 2: Accumulation ratio (Rac) of Tislelizumab SC

    Measured: Up to approximately 3.5 months

  6. Part 2: Elimination half-life (t1/2) of Tislelizumab SC

    Measured: Up to approximately 3.5 months

  7. Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v5.0]), timing, seriousness, and relationship to study therapy.

    Measured: Up to approximately 27 months

Secondary outcomes (6)

  1. Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC

    Measured: Up to approximately 2 months

  2. Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by NCI-CTCAE v5.0), timing, seriousness, and relationship to study therapy.

    Measured: Up to approximately 27 months

  3. Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies

    Measured: Up to 25 months

  4. Part 2: Overall Response Rate (ORR) of Tislelizumab SC

    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

    Measured: Up to approximately 27 months

  5. Part 2: Duration of Response (DOR) of Tislelizumab SC

    DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death due to any cause, whichever occurs first as assessed by the investigator.

    Measured: Up to approximately 27 months

  6. Part 2: Progression-Free Survival (PFS)

    PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: Up to approximately 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start16 Nov 2023
  3. Primary completion31 Jul 2025
  4. Study completion4 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06091943
Sponsor's protocol ID
BGB-A317-103
Other IDs
CTR20233814
Status last verified
Aug 2026
First submitted
16 Oct 2023
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Publications

  • Liu X, Guan Y, Liu Y, Yu T, Abdrashitov R, Niu Z, Lin X, Ye X, Wang Y, Sahasranaman S, Hanley WD, Budha N. Model-Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer. Clin Transl Sci. 2026 Jul;19(7):e70649. doi: 10.1111/cts.70649.

    PubMed 42337921

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab IV, Tislelizumab SC and Histology-Based Chemotherapy Doublet in people with Non-small Cell Lung Cancer, run by BeiGene at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China, Georgia, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC (time frame: Up to approximately 3.5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06091943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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