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

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).

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab IV; Drug: Tislelizumab SC; Drug: Histology-Based Chemotherapy Doublet

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Jining, Shandong, China, 272002
      • Jining No Peoples Hospital East Branch
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China, 030013
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Deyang, Sichuan, China, 618000
      • Deyangs People Hospital
  • Zhejiang
    • Huzhou, Zhejiang, China, 313003
      • Huzhou Central Hospital
• Georgia
  • Tbilisi, Georgia, 0112
    • ARENSIA Exploratory Medicine LLC
• Moldova
  • Chisinau, Moldova, 2025
    • The Institute of Oncology, Arensia Exploratory Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose/Injection Site Exploration; Different 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.	Drug: Tislelizumab IV; Planned doses will be administered intravenously.; Other Names: BGB-A317 IV; Drug: Tislelizumab SC; Planned doses will be administered via subcutaneous injection.; Other Names: BGB-A317 SC; Drug: Histology-Based Chemotherapy Doublet; 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.
Experimental: Part 2: Dose Expansion; The 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.	Drug: Tislelizumab SC; Planned doses will be administered via subcutaneous injection.; Other Names: BGB-A317 SC; Drug: Histology-Based Chemotherapy Doublet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC		Up to approximately 3.5 months
Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC		Up to approximately 3.5 months
Part 1: Bioavailability of Tislelizumab SC		Up to approximately 2 months
Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC		Up to approximately 3.5 months
Part 2: Accumulation ratio (Rac) of Tislelizumab SC		Up to approximately 3.5 months
Part 2: Elimination half-life (t1/2) of Tislelizumab SC		Up to approximately 3.5 months
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.	Up to approximately 27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC		Up to approximately 2 months
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.	Up to approximately 27 months
Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies		Up to 25 months
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).	Up to approximately 27 months
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.	Up to approximately 27 months
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.	Up to approximately 27 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): August 4, 2026

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer; non-small cell lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: BGB-A317-103; CTR20233814 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No