Non-small Cell Lung CancerPhase 2NCT05816252
A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
A Phase 2 study testing SKB264, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by Klus Pharma Inc. at 50 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- SKB264, Pembrolizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 50 sitesin 6 countries
- Study dates
- 19 Apr 2023to 30 Dec 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
- Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation;
- Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment;
- Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
- Subject must have at least one radiographically measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria;
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- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1;
- Life expectancy at least 3 months for the subject;
- Adequate organ function;
- Subjects must have recovered from all toxicities led by prior treatment;
- Contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects;
- Subjects should voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Who cannot join
- Subjects with mixed SCLC histopathological features;
- Subjects with a known history of prior malignancy;
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
- Subjects with ≥ Grade 2 peripheral neuropathy;
- Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome;
- Subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease;
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- Subjects who suffer from cardiovascular diseases of clinical significance;
- Subjects with a history of interstitial lung disease (ILD)/non-infectious pneumonitis that required steroids;
- Subjects with uncontrolled systemic disease as judged by the Investigator;
- Subjects with active autoimmune disease that required systemic treatment in the past 2 years;
- Subjects with active hepatitis B or hepatitis C;
- Subjects with known history of Human Immunodeficiency Virus (HIV)
- Subjects with known active tuberculosis;
- Subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;
- Subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention;
- Subjects with other circumstances that, in the opinion of the Investigator, are not appropriate for participation in this study.
Trial locations and contacts
50 sites in 6 countries.
50 sites in 6 countries
China27 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130021
The First Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Cancer Hospital
Changsha, Hunan, 410013
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Chongqing, Chongqing Municipality, 400000
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Sun Yatsen University Cancer Center Huangpu Hos
Guangzhou, Guangdong, 510700
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
The First Hospital of Chinese Medical University(Heping Compus)
Shenyang, Liaoning, 110002
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30009
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Zhengzhou, Henan, 450052
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 45008
Spain8 sites
Micancer Center S.L.P.
Barcelona, 08017
Hospital Universitari Dexeus Grupo Quironsalud
Barcelona, 08028
Hospital Universitari Vall D Hebron
Barcelona, 08035
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Madrid, 28222
Hospital Quironsalud Malaga
Málaga, 29004
Hospital Universitario QuirónSalud Madrid
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario Virgen de Valme
Seville, 41014
Hospital Clinico Universitario De Valencia
Valencia, 46010
South Korea5 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 6351
Severance Hospital, Yonsei University Health System
Seoul, 03722
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, 16247
Turkey (Türkiye)5 sites
Medical Park Seyhan Hospital
Adana, 01140
Adana City Training and Research Hospital
Adana, 01370
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
Ankara, 06010
Hacettepe University Medical Faculty
Ankara, 06230
Gazi University Medical Faculty
Ankara, 06500
Georgia3 sites
ISR-GEO Med Res Clin Healthycore
Tbilisi, 0112
LLC "Todua Clinic"
Tbilisi, 0112
Ltd New Hospitals
Tbilisi, 0114
Romania2 sites
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Cluj, 400015
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, 200542
About this study
Official title: A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Read the detailed description
This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- SKB264, Pembrolizumab, Carboplatin, Osimertinib
- 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.
SKB264Drug
Also called MK-2870, Sacituzumab Tirumotecan (Sac-TMT)
intravenous (IV) infusion (Q2W or Q3W)
PembrolizumabDrug
Also called MK-3475
intravenous (IV) infusion (400mg, Q6W)
CarboplatinDrug
Also called Carboplatin for injection
intravenous (IV) infusion (AUC5, Q3W)
OsimertinibDrug
Also called Osimertinib Mesylate
80mg, QD
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1% | Experimental | SKB264 (Dose Level 1) + Pembrolizumab Receives: Drug: SKB264; Drug: Pembrolizumab |
| Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level | Experimental | SKB264 (Dose Level 1') + Pembrolizumab + Carboplatin Receives: Drug: SKB264; Drug: Pembrolizumab; Drug: Carboplatin |
| Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level | Experimental | SKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin Receives: Drug: SKB264; Drug: Pembrolizumab; Drug: Carboplatin |
| Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy | Experimental | SKB264 (Dose Level 1') + Carboplatin Receives: Drug: SKB264; Drug: Carboplatin |
| Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy | Experimental | SKB264 (Dose Level 1'') + Carboplatin Receives: Drug: SKB264; Drug: Carboplatin |
| Cohort 7 1L NSCLC with EGFR mutation | Experimental | SKB264 (Dose Level 1) + Osimertinib Receives: Drug: SKB264; Drug: Osimertinib |
| Cohort 7-1 1L NSCLC with EGFR mutation | Experimental | SKB264 (Dose Level 2) + Osimertinib Receives: Drug: SKB264; Drug: Osimertinib |
| Cohort 9 2/3L NSCLC EGFR/ALK negative | Experimental | SKB264 (Dose Level 1) Receives: Drug: SKB264 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
Measured: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
ORR
Objective response rate (ORR) per RECIST v1.1
Measured: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Secondary outcomes (3)
Duration of response (DOR)
For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first
Measured: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Progression-free survival (PFS)
The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first
Measured: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Overall survival (OS)
the time period from the start of study intervention to death due to any cause.
Measured: From baseline until death due to any cause, up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start19 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klus Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816252
- Sponsor's protocol ID
- SKB264-II-04
- Other IDs
- MK-2870-003, 2023-507270-41-00, 2023
- Status last verified
- Jan 2026
- First submitted
- 3 Apr 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SKB264 as Monotherapy or as Combination Therapy in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05816252
- Acronym / sponsor ID
- SKB264-II-04
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Klus Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
Detailed description
This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1% | Experimental | Drug: SKB264, Drug: PembrolizumabSKB264 (Dose Level 1) + Pembrolizumab |
| Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level | Experimental | Drug: SKB264, Drug: Pembrolizumab, Drug: CarboplatinSKB264 (Dose Level 1') + Pembrolizumab + Carboplatin |
| Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level | Experimental | Drug: SKB264, Drug: Pembrolizumab, Drug: CarboplatinSKB264 (Dose Level 1'') + Pembrolizumab + Carboplatin |
| Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy | Experimental | Drug: SKB264, Drug: CarboplatinSKB264 (Dose Level 1') + Carboplatin |
| Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy | Experimental | Drug: SKB264, Drug: CarboplatinSKB264 (Dose Level 1'') + Carboplatin |
| Cohort 7 1L NSCLC with EGFR mutation | Experimental | Drug: SKB264, Drug: OsimertinibSKB264 (Dose Level 1) + Osimertinib |
| Cohort 7-1 1L NSCLC with EGFR mutation | Experimental | Drug: SKB264, Drug: OsimertinibSKB264 (Dose Level 2) + Osimertinib |
| Cohort 9 2/3L NSCLC EGFR/ALK negative | Experimental | Drug: SKB264SKB264 (Dose Level 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects must be at least 18 years of age on day of signing informed consent, regardless of gender;
- Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC ;
- Subjects for NSCLC should be confirmed to be EGFR (Epidermal growth factor receptor) wild-type and ALK (Anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor EGFR mutation;
- Locally advanced or metastatic NSCLC subjects without actionable EGFR mutations and ALK fusion genes, no prior systemic treatment; subjects with EGFR mutation, no prior systemic treatment or failed prior EGFR-TKI (Tyrosine kinase inhibitor) treatment;
- Subjects are able to provide tumor blocks or slides before the first dose of study intervention;
Key exclusion criteria (17 listed)
- Subjects with mixed SCLC histopathological features;
- Subjects with a known history of prior malignancy;
- Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases;
- Subjects with ≥ Grade 2 peripheral neuropathy;
- Subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKB264Also: MK-2870, Sacituzumab Tirumotecan (Sac-TMT)intravenous (IV) infusion (Q2W or Q3W) | Drug | Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%, Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level, Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level, Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy, Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy, Cohort 7 1L NSCLC with EGFR mutation, Cohort 7-1 1L NSCLC with EGFR mutation, Cohort 9 2/3L NSCLC EGFR/ALK negative |
| PembrolizumabAlso: MK-3475intravenous (IV) infusion (400mg, Q6W) | Drug | Cohort 1 1L NSCLC, EGFR/ALK negative and PD-L1 TPS ≥ 1%, Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level, Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level |
| CarboplatinAlso: Carboplatin for injectionintravenous (IV) infusion (AUC5, Q3W) | Drug | Cohort 3 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level, Cohort 4 1L NSCLC, EGFR/ALK negative, regardless of PD-L1 expression level, Cohort 5 NSCLC with EGFR mutation and after failure of EGFR TKI therapy, Cohort 6 NSCLC with EGFR mutation and after failure of EGFR TKI therapy |
| OsimertinibAlso: Osimertinib Mesylate80mg, QD | Drug | Cohort 7 1L NSCLC with EGFR mutation, Cohort 7-1 1L NSCLC with EGFR mutation |
Primary outcome
Safety and tolerability
Time frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
ORR
Time frame: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Objective response rate (ORR) per RECIST v1.1
3 secondary outcomes
Duration of response (DOR)
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Progression-free survival (PFS)
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Overall survival (OS)
Time frame: From baseline until death due to any cause, up to approximately 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB264, Pembrolizumab and Carboplatin in people with Non-small Cell Lung Cancer, run by Klus Pharma Inc. at 50 sites in 6 countries.
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 12 inclusion and 17 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China, Spain, South Korea, Turkey (Türkiye), Georgia and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability (time frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.