Non-small Cell Lung Cancer Stage IIPhase 1NCT06268613
A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy
A Phase 1 study testing SB27, EU sourced Keytruda and US sourced Keytruda in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage IIIA, run by Samsung Bioepis Co., Ltd. at 24 sites in 4 countries.
Trial summary
The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage IIIA
- What is being tested?
- SB27, EU sourced Keytruda and US sourced Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 16 Jan 2024to Nov 2026
- Phase
- Phase 1
- 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
- Male or female aged 18 years or older
- Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
- Have completely removed all of the cancer from the body surgically
- Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery
Who cannot join
- Have received anti-cancer therapy before surgery
- Have or had autoimmune disease in past 5 years
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
South Korea14 sites
SB Investigative Site
Ansan
SB Investigative Site
Busan
SB Investigative Site
Daegu
SB Investigative Site
Hwasun
SB Investigative Site
Incheon
SB Investigative Site
Jinju
SB Investigative Site
Seongnam
SB Investigative Site 3
Seoul
SB Investigative Site 4
Seoul
SB Investigative Site 5
Seoul
SB Investigative Site 6
Seoul
SB Investigative Site 1
Suwon
SB Investigative Site 2
Suwon
SB Investigative Site
Ulsan
Turkey (Türkiye)5 sites
SB Investigative Site
Adana
SB Investigative Site 1
Ankara
SB Investigative Site 2
Ankara
SB Investigative Site
Istanbul
SB Investigative Site
Izmir
Spain3 sites
SB Investigative Site
A Coruña, Santiago de Compostela
SB Investigative Site
Jaén, Jaén
SB Investigative Site
Málaga
About this study
Official title: A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy
The goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:
- What the body does to the study drug, which is called "pharmacokinetic"
Read more
Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.
Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.
- Being tested
- SB27, EU sourced Keytruda, US sourced Keytruda
- 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.
SB27Drug
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
EU sourced KeytrudaDrug
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
US sourced KeytrudaDrug
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
| Study group | Role | What they receive |
|---|---|---|
| SB27 | Experimental | SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks Receives: Drug: SB27 |
| EU sourced Keytruda | Active comparator | EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks Receives: Drug: EU sourced Keytruda |
| US sourced Keytruda | Active comparator | EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks Receives: Drug: US sourced Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1
Defined as AUC calculated in Cycle 1 based on intensive PK assessment
Measured: At the end of Cycle 1 (each cycle is 21 days)
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
Defined as AUC calculated in Cycle 6 based on intensive PK assessment
Measured: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (2)
Disease-free Survival
Defined as the time from the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first.
Measured: From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55
Overall Survival
Defined as the time from the date of randomization until the date of death of any cause.
Measured: From the date of randomization until the date of death of any cause, assessed up to Week 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start16 Jan 2024
- Primary completion19 Feb 2026
- Study completionNov 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 Cancer Stage IIStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268613
- Sponsor's protocol ID
- SB27-1005
- Status last verified
- May 2026
- First submitted
- 2 Feb 2024
- Last updated
- 5 May 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Double-blind, Three-arm, Parallel Group, Multicentre Study to Compare the Pharmacokinetics (PK), Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, European Union [EU] Sourced Keytruda, and the United States of America [US] Sourced Keytruda) in Subjects With Stage II-IIIA Non-small Cell Lung Cancer Following Complete Resection and Adjuvant Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT06268613
- Acronym / sponsor ID
- SB27-1005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Feb 2024 (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 goal of this clinical trial is to compare the amount of study drug in patients' blood to confirm that SB27 works in the same way as EU and US sourced Keytruda in early or locally advanced non-small cell lung cancer (NSCLC) patients who underwent surgery and adjuvant chemotherapy. The main question it aims to answer is:
- What the body does to the study drug, which is called "pharmacokinetic"
Participants will receive investigational product (IP) administration every 3 weeks, maximum 18 cycles over about 51 weeks and blood sample will be collected.
Researchers will compare 3 medicines (SB27, EU sourced Keytruda, and US sourced Keytruda) to see if SB27 works in the same way as EU and US sourced Keytruda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SB27 | Experimental | Drug: SB27SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
| EU sourced Keytruda | Active comparator | Drug: EU sourced KeytrudaEU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
| US sourced Keytruda | Active comparator | Drug: US sourced KeytrudaEU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years or older
- Diagnosed as NSCLC stage II-IIIA (staging should be confirmed after surgery)
- Have completely removed all of the cancer from the body surgically
- Have been received 3 or 4 cycles of platinum-based chemotherapy after surgery
Key exclusion criteria (2 listed)
- Have received anti-cancer therapy before surgery
- Have or had autoimmune disease in past 5 years
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 |
|---|---|---|
| SB27Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks | Drug | SB27 |
| EU sourced KeytrudaWill be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks | Drug | EU sourced Keytruda |
| US sourced KeytrudaWill be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks | Drug | US sourced Keytruda |
Primary outcome
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Defined as AUC calculated in Cycle 1 based on intensive PK assessment
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 6
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Defined as AUC calculated in Cycle 6 based on intensive PK assessment
2 secondary outcomes
Disease-free Survival
Time frame: From the date of randomization until the date of disease recurrence, occurrence of new primary NSCLC, or death of any cause, whichever occurs first, assessed up to Week 55
Overall Survival
Time frame: From the date of randomization until the date of death of any cause, assessed up to Week 55
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 5 May 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.
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB27, EU sourced Keytruda and US sourced Keytruda in people with Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage IIIA, run by Samsung Bioepis Co., Ltd. at 24 sites in 4 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 4 inclusion and 2 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 5 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 24 sites in South Korea, Turkey (Türkiye), Spain, Poland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area Under the Concentration-time Curve (AUC) over the Dosing Interval at Cycle 1 (time frame: At the end of Cycle 1 (each cycle is 21 days)). 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 5 May 2026.