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Immunotherapy combo shows promise against Early-Stage lung cancer

NCT ID NCT04379635

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 study tests whether adding the immunotherapy drug tislelizumab to standard chemotherapy before and after surgery helps people with stage II or IIIA non-small cell lung cancer. About 453 participants will receive either tislelizumab plus chemo or a placebo plus chemo, followed by tislelizumab or placebo alone after surgery. The main goals are to see if the tumor shrinks more and if the cancer takes longer to return.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

453 people

The number who actually took part.

Started

May 2020

Expected to finish

Mar 2027

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. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 2. Histologically confirmed Stage II or IIIA NSCLC 3. Measurable disease as assessed per RECIST v1.1 4. Confirm eligibility for an R0 resection with curative intent Key Exclusion Criteria: 1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy 2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation 3. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization 4. Active autoimmune diseases or history of autoimmune diseases that may relapse 5. History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

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

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032, China

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510030, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004, China

  • Hainan Cancer Hospital

    Haikou, Hainan, 570312, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No2 Hospital)

    Ningbo, Zhejiang, 315000, China

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529030, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Luoyang Central Hospital

    Luoyang, Henan, 471009, China

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008, China

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan, 610041, China

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

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