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New drug duo aims to slow advanced lung cancer in first-line trial

NCT ID NCT06448312

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding the experimental drug SKB264 to the standard immunotherapy pembrolizumab works better than pembrolizumab alone for people with advanced non-small cell lung cancer that has a specific marker (PD-L1 positive). About 406 participants who have not had prior treatment for advanced disease will receive either the combination or the standard drug. The main goal is to see if the combination delays cancer growth or improves survival.

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

About 406 people

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

Started

Jun 2024

Expected to finish

Nov 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 to 75 years

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:Key Inclusion Criteria: 1. Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy. 2. No prior systemic anti-cancer therapy for locally advanced or metastatic disease. 3. Participants whose tumours are PD-L1 TPS ≥ 1%. 4. At least one measurable lesion per RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization. 6. A life expectancy of at least 12 weeks. 7. Adequate organ and bone marrow function. Exclusion Criteria:Key Exclusion Criteria: 1. Active second malignancy. 2. Uncontrolled or clinical significant cardiovascular disease. 3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. 4. Active infection requiring systemic therapy within 2 weeks of randomization. 5. Active hepatitis B or hepatitis C virus infection. 6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 7. Known allergy to SKB264 or pembrolizumab or any of its components. 8. Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy): 1. Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4 antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy; 2. Therapy targeting TROP2. 3. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs). 9. Major surgery within 4 weeks prior to randomization or expected major surgery during the study. 10. Pregnant or lactating women.

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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 Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, China

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Xinjiang, China

  • Anhui Provincial Chest Hospital

    Hefei, China

  • Army Medical Center of PLA (Daping Hospital)

    Chongqing, China

  • Beijing Chest Hospital. Capital Medical University

    Beijing, China

  • Beijing Institute for Cancer Research

    Beijing, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, China

  • Chengdu Fifth People's Hospital

    Chengdu, China

  • China Medical University First Affiliated Hospital

    Shenyang, China

  • Chongqing University Cancer Hospital

    Chongqing, China

  • Dongguan People's Hospital

    Dongguan, China

  • Fujian Cancer Hospital

    Fuzhou, China

  • Fujian Medical University Union Hospital

    Fuzhou, China

  • Gansu Provincial Cancer Hospital

    Lanzhou, China

  • Guangxi Medical University Cancer Hospital

    Nanning, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Hebei University Affiliated Hospital

    Baoding, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Hunan Cancer Hospital

    Changsha, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jiangxi Cancer Hospital

    Nanchang, China

  • Jilin Cancer Hospital

    Changchun, China

  • Liaoning Cancer Hospital

    Shenyang, China

  • Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China

    Mianyang, China

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, China

  • Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, China

  • Shandong Provincial Hospital

    Jinan, China

  • Shanghai Chest Hospital

    Shanghai, China

  • Shanghai East Hospital, Tongji University

    Shanghai, China

  • Shanghai Pulmonary Hospital

    Shanghai, China

  • Shanxi Province Cancer Hospital

    Taiyuan, China

  • Shengjing Hospital, China Medical University

    Shenyang, China

  • Sichuan Provincial People's Hospital

    Chengdu, China

  • Sir Run Run Shaw Hospital (SRRSH)

    Hangzhou, China

  • Subei People's Hospital of Jiangsu province

    Yangzhou, China

  • Sun Yat-sen Memorial Hospital Sun Yat-sen University

    Guangzhou, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, China

  • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital，Henan Academy of Innovations in Medical Science

    Zhengzhou, China

  • The First Affiliated Hospital Of Xiamen University

    Xiamen, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, China

  • The First Affiliated Hospital of XiAn Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The First Hospital of Jilin University

    Changchun, China

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, China

  • The Second Affiliated Hospital Of Zunyi Medical University

    Zunyi, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, China

  • The Second Affiliated Hospital of XiAn Jiaotong University

    Xi'an, China

  • The Second People's Hospital of Hunan Province（Brain Hospital of Hunan Province）

    Changsha, China

  • The Southwest Hospital Of AMU

    Chongqing, China

  • The Third Affiliated Hospital of Kunming Medical University Yunnan Cancer Hospital

    Kunming, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, China

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

    Wuhan, China

  • University of Electronic Science and Technology of China, Sichuan Cancer Hospital and Institute & Cancer, The Second People's Hospital of Sichuan Province

    Chengdu, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Xiangya Second Hospital of Central South University

    Changsha, China

  • Xiangyang Central Hospital

    Xiangyang, China

  • Yibin Second People's Hospital

    Yibin, China

  • Yuebei People's Hospital

    Shaoguan, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

  • Zhongshan Hospital of Fudan University

    Shanghai, China

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