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New hope for lung cancer: immunotherapy cocktail under study

NCT ID NCT05635708

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing whether combining the immunotherapy drug tislelizumab with other experimental drugs, with or without chemotherapy, can shrink tumors and control advanced non-small cell lung cancer. About 400 people who have not had prior treatment for metastatic disease will participate. The study is divided into two groups based on a protein marker (PD-L1) level to see which combinations work best.

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) combined with other investigational drugs and/or chemotherapy
What this could lead to
If successful, this could lead to better treatment options for people with advanced lung cancer, potentially improving tumor shrinkage and delaying disease progression.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. The combination therapies may cause side effects or not work better than existing treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Key Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. 2. No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment. 3. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible. 4. At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Key Exclusion Criteria: 1. Diagnosis of mixed small cell lung cancer. 2. Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to: * Epidermal growth factor receptor (EGFR) mutations * Anaplastic lymphoma kinase (ALK) rearrangements * B-Raf proto-oncogene (BRAF) mutations * Rearranged during transfection (RET) fusions * c-ros oncogene 1 (ROS1) rearrangements 3. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded. 4. Prior treatment with immune-based therapies that target immune checkpoint pathways, including: * PD-1 (programmed cell death protein 1) inhibitors * PD-L1 (programmed death-ligand 1) inhibitors * PD-L2 (programmed death-ligand 2) inhibitors * TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors * LAG-3 (lymphocyte activation gene 3) inhibitors 5. Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present. 6. Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment. 7. Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease. Note: Additional protocol-defined and sub-study-specific criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000, China

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112, Georgia

  • Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu

    ClujNapoca, 400015, Romania

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148, Australia

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270, Brazil

  • Centro Ricerche Cliniche Di Verona

    Verona, 37126, Italy

  • Chris Obrien Lifehouse

    Camperdown, New South Wales, NSW 2050, Australia

  • Chu Nantes Hopital Nord Laennec

    SaintHerblain, 44805, France

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbukdo, 28644, South Korea

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000, Brazil

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hospital Do Cancer de Londrina

    Londrina, 86015-520, Brazil

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital de Amor Barretos

    Barretos, 14784-400, Brazil

  • Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

    Ongkharak, 26120, Thailand

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000, Brazil

  • Institut Curie

    Paris, 75005, France

  • Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

    Bucureti, 022328, Romania

  • Jining No1 Peoples Hospital East Branch

    Jining, Shandong, 272002, China

  • Linyi Peoples Hospital

    Linyi, Shandong, 276000, China

  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

    Muang, 50200, Thailand

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York, 10065-6800, United States

  • Nantong Tumor Hospital Branch North

    Nantong, Jiangsu, 226000, China

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, NSW 2086, Australia

  • One Clinical Research

    Nedlands, Western Australia, WA 6009, Australia

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, NSW 2444, Australia

  • Providence Portland Medical Center

    Portland, Oregon, 97213-2933, United States

  • Pulau Pinang Hospital

    George Town, 10450, Malaysia

  • Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs

    Roma, 00144, Italy

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai Municipality, 200123, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110, Thailand

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002, Thailand

  • St John of God Health Care

    Subiaco, Western Australia, WA 6008, Australia

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang, 317000, China

  • Tengku Ampuan Afzan Hospital

    Kuantan, 25100, Malaysia

  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

  • The Fifth Medical Center of Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025, Moldova

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067-2011, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.