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NCT Number: NCT06091943

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab IV

Drug

Planned doses will be administered intravenously.

Other names: BGB-A317 IV

Tislelizumab SC

Drug

Planned doses will be administered via subcutaneous injection.

Other names: BGB-A317 SC

Histology-Based Chemotherapy Doublet

Drug

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.

Primary outcomes

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

    Time frame: Up to approximately 3.5 months

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

    Time frame: Up to approximately 3.5 months

  3. Part 1: Bioavailability of Tislelizumab SC

    Time frame: Up to approximately 2 months

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

    Time frame: Up to approximately 3.5 months

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

    Time frame: Up to approximately 3.5 months

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

    Time frame: Up to approximately 3.5 months

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

    Time frame: Up to approximately 27 months

    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.

Secondary outcomes

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

    Time frame: Up to approximately 2 months

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

    Time frame: Up to approximately 27 months

    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.

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

    Time frame: Up to 25 months

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

    Time frame: Up to approximately 27 months

    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).

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

    Time frame: Up to approximately 27 months

    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.

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

    Time frame: Up to approximately 27 months

    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.

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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