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NCT05577702CompletedPhase 2

Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations in Participants With Resectable Non-Small Cell Lung Cancer

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 9 Feb 2026

Brief summary (registry, in English)

This study was conducted to evaluate the preliminary effectiveness and safety of treatment with tislelizumab alone and in combination with other investigational agents prior to surgery (neoadjuvant treatment) in adults with non-small cell lung cancer (NSCLC) that is able to be removed by surgery.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
121 (actual)
First submitted
10 Oct 2022
Start date
8 Mar 2023
Primary completion date
13 Dec 2024
Lead sponsor
BeiGene
Diseases
Lung cancer
NCT number
NCT05577702

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 121
  • From 8 Mar 2023 to the primary completion date, 13 Dec 2024
  • 14 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior antineoplastic therapy(ies) for current lung cancer (eg, radiotherapy, targeted therapies, ablation, or other systemic or local antineoplastic treatment)

Other illness

  • Has mixed small cell lung cancer
  • The presence of locally advanced unresectable NSCLC regardless of stage or metastatic disease

Lab values

  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-cell immunoglobulin and ITIM domain (TIGIT), anti-lymphocyte activation gene-3 (LAG-3), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Known epidermal growth factor receptor (EGFR) sensitizing mutations and/or anaplastic lymphoma kinase (ALK) rearrangement
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Participants with large cell neuroendocrine carcinoma (LCNEC)

Who the study is looking for

  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • Histologically confirmed Stage II-IIIA NSCLC (per the Eighth American Joint Committee on Cancer/Union Internationale Contre le Cancer \[NSCLC\] staging system)
  • Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
  • Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained ≤ 7 days before randomization
  • Provide formalin-fixed paraffin-embedded block (preferred) or at least 15 freshly cut unstained FFPE slides of the primary tumor for biomarker evaluation during screening

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Anyang Cancer Hospital
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AnyangChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical Universitydatansha Hospital)
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GuangzhouChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
The First Affiliated Hospital of Nanchang University Branch Xianghu
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NanchangChinaUnknown status
The Tumor Hospital Affiliated to Guangxi Medical University
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NanningChinaUnknown status
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
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NingboChinaUnknown status
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Liaoning Cancer Hospital and Institute
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ShenyangChinaUnknown status
Hubei Cancer Hospital
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WuhanChinaUnknown status
The First Affiliated Hospital of Wannan Medical College
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WuhuChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.