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Could a simple shot replace IV drips for lung cancer immunotherapy?

NCT ID NCT06091943

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether an immunotherapy drug called tislelizumab can be given as a simple injection under the skin instead of through an IV drip for people with advanced non-small cell lung cancer. The study will compare how well the body absorbs the drug in both forms, when used alongside standard chemotherapy as the first treatment. The goal is to see if the easier injection method works just as well, which could make treatment more convenient for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (an immunotherapy drug) given as a subcutaneous injection or intravenously, combined with chemotherapy
What this could lead to
If successful, this could offer a more convenient way to deliver immunotherapy for lung cancer, potentially improving patient comfort and access.
What could go wrong
This is an early-phase study, so the subcutaneous form may not match the IV version in effectiveness or safety. Results are preliminary and need confirmation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

62 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112, Georgia

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Deyangs People Hospital

    Deyang, Sichuan, 618000, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313003, China

  • Jining No Peoples Hospital East Branch

    Jining, Shandong, 272002, China

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350025, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025, Moldova

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