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Non-Small Cell Lung CancerPhase 3NCT06448312

A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 3 study testing SKB264 and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 64 sites in China.

Active, not recruiting

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

Official record
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Trial summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 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 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
64 sitesChina
Study dates
7 Jun 2024to Nov 2026
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 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.
  • No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
  • 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

  • Active second malignancy.
  • Uncontrolled or clinical significant cardiovascular disease.
  • 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.
  • Active hepatitis B or hepatitis C virus infection.
  • Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
Show all 13Show fewer
  • Known allergy to SKB264 or pembrolizumab or any of its components.
  • Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):
  • 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;
  • Therapy targeting TROP2.
  • Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
  • Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
  • Pregnant or lactating women.

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

China64 sites

  • Hebei University Affiliated Hospital

    Baoding

  • Beijing Chest Hospital. Capital Medical University

    Beijing

  • Beijing Institute for Cancer Research

    Beijing

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

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

    Changsha

  • Xiangya Second Hospital of Central South University

    Changsha

  • Chengdu Fifth People's Hospital

    Chengdu

  • Sichuan Provincial People's Hospital

    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 Southwest Hospital Of AMU

    Chongqing

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian

  • Dongguan People's Hospital

    Dongguan

  • Fujian Cancer Hospital

    Fuzhou

  • Fujian Medical University Union Hospital

    Fuzhou

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou

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

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • Sir Run Run Shaw Hospital (SRRSH)

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin

  • 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 Yunnan Cancer Hospital

    Kunming

  • Gansu Provincial Cancer Hospital

    Lanzhou

  • 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

  • Jiangsu Province Hospital

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

  • Shanghai Chest Hospital

    Shanghai

  • Shanghai East Hospital, Tongji University

    Shanghai

  • Shanghai Pulmonary Hospital

    Shanghai

  • Zhongshan Hospital of Fudan University

    Shanghai

  • Yuebei People's Hospital

    Shaoguan

  • China Medical University First Affiliated Hospital

    Shenyang

  • Liaoning Cancer Hospital

    Shenyang

  • Shengjing Hospital, China Medical University

    Shenyang

  • Shanxi Province Cancer Hospital

    Taiyuan

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin

  • Hubei Cancer Hospital

    Wuhan

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

    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

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Xinjiang

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • Subei People's Hospital of Jiangsu province

    Yangzhou

  • Yibin Second People's Hospital

    Yibin

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

    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 III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

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 pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.

Being tested
SKB264, Pembrolizumab
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 NCT06448312
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
PembrolizumabActive comparatorParticipants will receive Pembrolizumab on Day 1 of each 6-week cycle.
Receives: Drug: Pembrolizumab

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 22months

Secondary outcomes (11)

  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 40 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 22months

  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 22months

  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 22months

  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 22months

  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 22months

  7. Health-Related Quality of Life Assessment

    Compare the health-related quality of life (HRQoL) of SKB264 in combination with pembrolizumab and pembrolizumab monotherapy by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire - Lung Cancer Module 13 (EORTC QLQ-LC13)

    Measured: Randomization up to approximately 22months

  8. 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.

  9. 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 22months

  10. Immunogenicity

    Immunogenicity test results of SKB264

    Measured: Randomization up to approximately 22months

  11. 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 posted7 Jun 2024
  2. Study start7 Jun 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (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
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06448312
Sponsor's protocol ID
SKB264-Ⅲ-12
Status last verified
May 2026
First submitted
3 Jun 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xiong A, Yao W, Zheng W, Yu Y, Chen P, Zhong H, Ge J, Wang H, Chen B, Wang H, Fan Y, Yang Y, Pu X, Song X, Wang Q, Du X, Huang Z, Li X, Luo H, Yao Y, Yu Q, Su C, He L, Jiang G, Cui J, Liu C, Yi T, Che G, Liu Z, Zhang L, Zhou M, Fang Y, Wei Y, Qing Y, Jin X, Zhou C. Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. Lancet. 2026 Jun 27;407(10548):2607-2619. doi: 10.1016/S0140-6736(26)00968-2. Epub 2026 May 29.

    PubMed 42214392

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SKB264 and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 64 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 7 inclusion and 13 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 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 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 22months). 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 NCT06448312, 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 May 2026.

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