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 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: BGB-A317-103CTR20233814
• Study Type: interventional
• Target: 62
• Locations: 3 countries
• Sites: 15

Brief 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). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; non-small cell lung cancer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• 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)

  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

  Up to approximately 27 months

• Part 2: Duration of Response (DOR) of Tislelizumab SC

  Up to approximately 27 months

Study Arms (2)

Part 1: Dose/Injection Site Exploration

EXPERIMENTAL

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; Drug: Tislelizumab SC; Drug: Histology-Based Chemotherapy Doublet

Part 2: Dose Expansion

EXPERIMENTAL

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; Drug: Histology-Based Chemotherapy Doublet

Interventions

Tislelizumab IV DRUG

Planned doses will be administered intravenously.

Also known as: BGB-A317 IV

Part 1: Dose/Injection Site Exploration

Tislelizumab SC DRUG

Planned doses will be administered via subcutaneous injection.

Also known as: BGB-A317 SC

Part 1: Dose/Injection Site Exploration; Part 2: Dose Expansion

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.

Part 1: Dose/Injection Site Exploration; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (15)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Jining No Peoples Hospital East Branch

Jining, Shandong, 272002, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

Deyangs People Hospital

Deyang, Sichuan, 618000, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, 313003, China

Location

Arensia Exploratory Medicine Llc

Tbilisi, 0112, Georgia

Location

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, 2025, Moldova

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 16, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

CN (13); GE (1); MO (1)