New hope for lung cancer patients who can't use standard immunotherapy alone

NCT ID NCT06711900

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests whether adding the experimental drug SKB264 to the immunotherapy pembrolizumab works better than standard chemotherapy plus pembrolizumab for people with advanced non-squamous lung cancer that lacks the PD-L1 protein. About 432 adults with stage IIIB/IV disease who haven't had prior treatment will be enrolled. The goal is to see if the new combination delays cancer growth and improves survival.

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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 432 people

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

Started

Oct 2024

Expected to finish

Dec 2028

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: 1. Histologically or cytologically confirmed non-squamous NSCLC, and unsuitable for radical surgery and/or radical concurrent/sequential radiochemotherapy, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC; 2. EGFR-sensitive mutation negative \[no exon 19 deletion (19-Del) or exon 21 point mutation (L858R mutation)\] and ALK fusion gene negative, without known ROS1 gene fusion, NTRK gene fusion, BRAF V600E mutation, etc. that have been approved for targeted therapy driving gene alterations; 3. No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC; 4. Participants whose tumours are PD-L1 TPS \< 1%; 5. At least one measurable lesion per RECIST v1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization; 7. A life expectancy of at least 12 weeks; 8. Adequate organ and bone marrow function; Exclusion Criteria: 1. Histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%; 2. Previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy; 3. Active second malignancy; 4. Symptomatic or uncontrolled cardiovascular disease，serious thromboembolic； 5. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD; 6. Active infection requiring systemic therapy within 2 weeks of randomization; 7. Active hepatitis B or hepatitis C virus infection; 8. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 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 Hospital of Guilin Medical University

Guilin, China
Affiliated Hospital of North Sichuan Medical College

Nanchong, China
Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, China
Anhui Provincial Chest Hospital

Hefei, China
Army Medical Center of PLA (Daping Hospital)

Chongqing, China
Beijing Cancer Hospital

Beijing, China
Beijing Chest Hospital. Capital Medical University

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
First Affiliated Hospital of Gannan Medical University

Ganzhou, China
Fujian Cancer Hospital

Fuzhou, China
Gansu Provincial Cancer Hospital

Lanzhou, China
General Hospital of Ningxia Medical University

Yinchuan, China
Guangxi Medical University Cancer Hospital

Nanning, China
Harbin Medical University Cancer Hospital

Ha’erbin, China
Henan Cancer Hospital

Zhengzhou, China
Huashan Hospital Affiliated to Fudan University

Shanghai, China
Hubei Cancer Hospital

Wuhan, China
Hunan Cancer Hospital

Changsha, China
Jiangsu Cancer Hospital

Nanjing, China
Jiangsu Province Hospital

Nanjing, China
Jiangxi Cancer Hospital

Nanchang, China
Jilin Cancer Hospital

Changcun, China
Liaoning Cancer Hospital

Shenyang, China
Linyi Cancer Hospital

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

Mianyang, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, China
Peking University Third Hospital

Beijing, 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 Oriental Hospital

Shanghai, China
Shanghai Pulmonary Hospital

Shanghai, China
Shanxi Province Cancer Hospital

Taiyuan, China
Shengjing Hospital, China Medical University

Shengyang, China
Sichuan Provincial People's Hospital

Chengdu, China
Sir Run Run Shaw Hospital (SRRSH)

Hangzhou, China
Sun Yat-sen University Cancer Center

Guangzhou, China
Taizhou Hospital of Zhejiang Province

Taizhou, China
The 2nd Affiliated Hospital of Harbin Medical University

Ha’erbin, China
The 900 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China

Fuzhou, China
The Affiliated Hospital of Qingdao University

Qingdao, China
The First Affiliated Hospital Of Xiamen University

Xiamen, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, China
The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 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 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 Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China
The First Hospital of Jilin University

Changchun, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, China
The General Hospital of Western Theater Command

Chengdu, 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 Army Medical University

Chongqing, China
The Second Affiliated Hospital of Dalian Medical University

Dalian, China
The Second Affiliated Hospital of XiAn Jiaotong University

Xi'an, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China
The Second People's Hospital of Neijiang

Neijiang, China
The Southwest Hospial Of AMU

Chongqing, China
The Third Affiliated Hospital of Kunming Medical University

Kunming, China
Tianjin Medical University Cancer Institute and Hospital

Tianjin, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 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
Weifang People's Hospital

Weifang, China
West China Hospital of Sichuan University

Chengdu, China
Xiangya Hospital, Central South University

Changsha, 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
Zhongnan Hospital of Wuhan University

Wuhan, China
Zhongshan Hospital of Fudan University

Shanghai, China

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