New hope for lung cancer: immunotherapy cocktail under study
NCT ID NCT05635708
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
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Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
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Arensia Exploratory Medicine Llc
Tbilisi, 0112, Georgia
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Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
ClujNapoca, 400015, Romania
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Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
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Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
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Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
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Centro Ricerche Cliniche Di Verona
Verona, 37126, Italy
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Chris Obrien Lifehouse
Camperdown, New South Wales, NSW 2050, Australia
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Chu Nantes Hopital Nord Laennec
SaintHerblain, 44805, France
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Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644, South Korea
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Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
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Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
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Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000, Brazil
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
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Hospital Do Cancer de Londrina
Londrina, 86015-520, Brazil
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital Universitario Vall Dhebron
Barcelona, 08035, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
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Hospital de Amor Barretos
Barretos, 14784-400, Brazil
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Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, 26120, Thailand
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Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000, Brazil
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Institut Curie
Paris, 75005, France
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Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
Bucureti, 022328, Romania
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Jining No1 Peoples Hospital East Branch
Jining, Shandong, 272002, China
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Linyi Peoples Hospital
Linyi, Shandong, 276000, China
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Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, 50200, Thailand
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800, United States
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Nantong Tumor Hospital Branch North
Nantong, Jiangsu, 226000, China
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National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea
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National Cancer Centre Singapore
Singapore, 168583, Singapore
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Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086, Australia
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One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
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Port Macquarie Base Hospital
Port Macquarie, New South Wales, NSW 2444, Australia
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Providence Portland Medical Center
Portland, Oregon, 97213-2933, United States
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Pulau Pinang Hospital
George Town, 10450, Malaysia
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Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Roma, 00144, Italy
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Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
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Sarawak General Hospital
Kuching, 93586, Malaysia
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
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Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
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Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123, China
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
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Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110, Thailand
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Srinagarind Hospital (Khon Kaen University)
Muang, 40002, Thailand
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St John of God Health Care
Subiaco, Western Australia, WA 6008, Australia
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Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, 317000, China
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Tengku Ampuan Afzan Hospital
Kuantan, 25100, Malaysia
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The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea
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The Fifth Medical Center of Chinese Pla General Hospital
Beijing, Beijing Municipality, 100071, China
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The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
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The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025, Moldova
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The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
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The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009, United States
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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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.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?