CompletedPhase 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

China, Georgia, Moldova62 participantsStarted 2023-11-16

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 treatme…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 3.5 months

Part 1: Bioavailability of Tislelizumab SC

Timeframe: Up to approximately 2 months

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

Timeframe: Up to approximately 3.5 months

Part 2: Accumulation ratio (Rac) of Tislelizumab SC

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 27 months

Trial details

NCT IDNCT06091943

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Non-small Cell Lung Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 3.5 months

Part 1: Bioavailability of Tislelizumab SC

Timeframe: Up to approximately 2 months

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

Timeframe: Up to approximately 3.5 months

Part 2: Accumulation ratio (Rac) of Tislelizumab SC

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 3.5 months

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

Timeframe: Up to approximately 27 months