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Non-Small Cell Lung CancerPhase 3NCT06711900

A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

A Phase 3 study testing SKB264, Pembrolizumab and pemetrexed in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 81 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
SKB264, Pembrolizumab and pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
432 participants
Where
81 sitesChina
Study dates
30 Oct 2024to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • 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;
  • No prior systemic anti-cancer therapy for locally advanced or metastatic NSCLC;
  • Participants whose tumours are PD-L1 TPS < 1%;
  • At least one measurable lesion per RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization;
  • A life expectancy of at least 12 weeks;
  • Adequate organ and bone marrow function;

Who cannot join

  • Histologically or cytologically confirmed tumors with a component of small cell lung cancer, neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell carcinoma exceeding 10%;
  • Previously received immune checkpoint inhibitors,checkpoint agonists or any treatment targeting the immune mechanism of tumors such as immune cell therapy;
  • Active second malignancy;
  • Symptomatic or uncontrolled cardiovascular disease，serious thromboembolic；
  • History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
  • Active infection requiring systemic therapy within 2 weeks of randomization;
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  • Active hepatitis B or hepatitis C virus infection;
  • Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
  • Major surgery within 4 weeks prior to randomization or expected major surgery during the study;
  • Pregnant or lactating women;

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

China81 sites

  • Beijing Cancer Hospital

    Beijing

  • Beijing Chest Hospital. Capital Medical University

    Beijing

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

  • Peking University Third Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun

  • Jilin Cancer Hospital

    Changcun

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital, Central South University

    Changsha

  • Xiangya Second Hospital of Central South University

    Changsha

  • Chengdu Fifth People's Hospital

    Chengdu

  • Sichuan Provincial People's Hospital

    Chengdu

  • The General Hospital of Western Theater Command

    Chengdu

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

    Chengdu

  • West China Hospital of Sichuan University

    Chengdu

  • Army Medical Center of PLA (Daping Hospital)

    Chongqing

  • Chongqing University Cancer Hospital

    Chongqing

  • The Second Affiliated Hospital of Army Medical University

    Chongqing

  • The Southwest Hospial Of AMU

    Chongqing

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian

  • Fujian Cancer Hospital

    Fuzhou

  • The 900 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China

    Fuzhou

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • Affiliated Hospital of Guilin Medical University

    Guilin

  • Harbin Medical University Cancer Hospital

    Ha’erbin

  • The 2nd Affiliated Hospital of Harbin Medical University

    Ha’erbin

  • Sir Run Run Shaw Hospital (SRRSH)

    Hangzhou

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Provincial Chest Hospital

    Hefei

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei

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

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • The Third Affiliated Hospital of Kunming Medical University

    Kunming

  • Gansu Provincial Cancer Hospital

    Lanzhou

  • Linyi Cancer Hospital

    Linyi

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

    Luoyang

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

    Mianyang

  • Jiangxi Cancer Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong

  • Jiangsu Cancer Hospital

    Nanjing

  • Jiangsu Province Hospital

    Nanjing

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

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

  • The Second People's Hospital of Neijiang

    Neijiang

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Huashan Hospital Affiliated to Fudan University

    Shanghai

  • Shanghai Chest Hospital

    Shanghai

  • Shanghai Oriental Hospital

    Shanghai

  • Shanghai Pulmonary Hospital

    Shanghai

  • Zhongshan Hospital of Fudan University

    Shanghai

  • Yuebei People's Hospital

    Shaoguan

  • Shengjing Hospital, China Medical University

    Shengyang

  • China Medical University First Affiliated Hospital

    Shenyang

  • Liaoning Cancer Hospital

    Shenyang

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Shanxi Province Cancer Hospital

    Taiyuan

  • Taizhou Hospital of Zhejiang Province

    Taizhou

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi

  • Weifang People's Hospital

    Weifang

  • Hubei Cancer Hospital

    Wuhan

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

    Wuhan

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

    Wuhan

  • Zhongnan Hospital of Wuhan University

    Wuhan

  • The First Affiliated Hospital of XiAn Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of XiAn Jiaotong University

    Xi'an

  • The First Affiliated Hospital Of Xiamen University

    Xiamen

  • Xiangyang Central Hospital

    Xiangyang

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • Yibin Second People's Hospital

    Yibin

  • General Hospital of Ningxia Medical University

    Yinchuan

  • Henan Cancer Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • The Second Affiliated Hospital Of Zunyi Medical University

    Zunyi

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 3 Clinical Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

The study aims to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

Read the detailed description

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab in the first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC with PD-L1 negative.

Being tested
SKB264, Pembrolizumab, pemetrexed, carboplatin or cisplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06711900
Study groupRoleWhat they receive
SKB264+PembrolizumabExperimentalParticipants will receive SKB264 on Day 1、Day 15 and Day 29 of each 6-week cycle,Pembrolizumab on Day1 of each 6-week cycle.
Receives: Drug: SKB264; Drug: Pembrolizumab
Pembrolizumab+ChemotherapyActive comparatorParticipants will receive Pembrolizumab on Day1 of each 6-week cycle,Chemotherapy on Day1 and Day 22 of each 6-week
Receives: Drug: Pembrolizumab; Drug: pemetrexed; Drug: carboplatin or cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

Secondary outcomes (12)

  1. Overall Survival (OS)

    OS is defined as the time from randomization until the date of death due to any cause.

    Measured: Randomization up to approximately 43 months

  2. Progression-Free Survival (PFS) assessed by Investigator

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

  3. Objective Response Rate (ORR)

    ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1

    Measured: Randomization up to approximately 28 months

  4. Disease control rate (DCR)

    DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/ investigator per RECIST 1.1

    Measured: Randomization up to approximately 28 months

  5. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.

    Measured: Randomization up to approximately 28 months

  6. Time to Response (TTR)

    TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.

    Measured: Randomization up to approximately 28 months

  7. AEs and SAEs

    Incidence and severity of AEs and SAEs (per CTCAE v5.0), and clinically significant abnormal laboratory results

    Measured: All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later.

  8. Health-Related Quality of Life Assessed by EORTC QLQ-C30

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is used to assess participants's health-related quality of life. The scale covers functional domains, symptom domains, and overall health status/total quality of life domain.

    All domain scores are standardized to a range of 0 to 100. For functional domains and overall health status/total quality of life, higher scores indicate better functional status and quality of life; for symptom domains, higher scores indicate more symptoms or problems (worse quality of life).

    This study will compare changes from baseline in quality-of-life scores across all dimensions, analyze time to deterioration in general health status, symptoms and function, and summarize the number and percentage of participants with clinically meaningful changes post-baseline.

    Measured: Randomization up to approximately 28months

  9. Lung Cancer-Related Symptoms Assessed by EORTC QLQ-LC13 Symptom Domain

    The symptom domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) is used to assess lung cancer-related symptoms and treatment-related symptoms. The scale includes both multiple-item and single-item measurement parameters.

    Scores are standardized to a range of 0 to 100. Higher scores indicate more severe symptoms (worse outcome).

    This study will compare changes from baseline in symptom scores, analyze time to deterioration of cancer-related symptoms, and summarize the number and percentage of participants with clinically meaningful changes post-baseline.

    Measured: From randomization up to approximately 28 months

  10. PK

    PK parameters of SKB264-ADC, SKB264-TAB and free KL610023, such as maximum concentration (Cmax), minimum concentration (Cmin ), etc.

    Measured: Randomization up to approximately 28months

  11. Immunogenicity

    Anti-drug antibody (ADA) of SKB264 in the serum of subjects will be determined using MSD-based Bridging-ECLA.

    Measured: Randomization up to approximately 28months

  12. Biomarkers

    Correlation between the expression level of TROP2 in tumor tissues and the efficacy.

    Measured: Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start30 Oct 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomised in a 1:1 ratio to one of two intervention groups.
Masking
None (open label)
Enrolment
432 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711900
Sponsor's protocol ID
SKB264-Ⅲ-14
Status last verified
May 2026
First submitted
22 Nov 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhou F, Meng X, Ding Q, Zhang P, Liang W, Guo S, Yu Y, Yao W, Fan Y, Pu X, Liu C, Cui J, Chen P, Zhong H, Wang Y, Huang Z, Xu Z, Dong X, Yi T, Hu Y, Wang Q, Chen B, Wang H, Sun L, He L, Zheng W, Wang Y, Zhang X, Yao Y, Li Y, Yang Z, Ye F, Song X, Zhou M, Yin L, Qing Y, Jin X, Ge J, Zhou C. Sacituzumab Tirumotecan plus Pembrolizumab in PD-L1-Negative Advanced NSCLC. N Engl J Med. 2026 Oct 25. doi: 10.1056/NEJMoa2611280. Online ahead of print.

    PubMed 42929694

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SKB264, Pembrolizumab and pemetrexed in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 81 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) (time frame: Randomization up to approximately 28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06711900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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