Non-small Cell Lung Cancer Stage IVPhase 3NCT06348199
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
A Phase 3 study testing SB27 and Keytruda in people with Non-small Cell Lung Cancer Stage IV, run by Samsung Bioepis Co., Ltd. at 93 sites in 14 countries.
Trial summary
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is: How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and… 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 IV
- What is being tested?
- SB27 and Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- 93 sitesin 14 countries
- Study dates
- 12 Mar 2024to Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Have been diagnosed with stage IV non-squamous NSCLC
- Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
- Agree to use adequate methods of contraception
Who cannot join
- Unable or unwilling to take folic acid and vitamin B12 supplementation
- Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
Trial locations and contacts
93 sites in 14 countries.
93 sites in 14 countries
Turkey (Türkiye)13 sites
SB Investigative Site
Adapazarı
SB Investigative Site 1
Ankara
SB Investigative Site 2
Ankara
SB Investigative Site
Bağcılar
SB Investigative Site
Balgat
SB Investigative Site
Çubuk
SB Investigative Site
Istanbul
SB Investigative Site
İzmit
SB Investigative Site
Kavaklıdere
SB Investigative Site
Konak
SB Investigative Site
Maltepe
SB Investigative Site
Seyhan
SB Investigative Site
Sivas
Japan10 sites
SB Investigative Site
Himeji
SB Investigative Site
Iwakuni
SB Investigative Site
Izumi
SB Investigative Site
Kawachi-Nagano
SB Investigative Site
Kobe
SB Investigative Site
Kochi
SB Investigative Site
Sagamihara
SB Investigative Site
Tachikawa
SB Investigative Site
Takarazuka
SB Investigative Site
Toyonaka
Brazil9 sites
SB Investigative Site
Curitiba
SB Investigative Site
Florianópolis
SB Investigative Site
Ijuí
SB Investigative Site
Natal
SB Investigative Site
Pelotas
SB Investigative Site 1
Porto Alegre
SB Investigative Site 2
Porto Alegre
SB Investigative Site
Rio de Janeiro
SB Investigative Site
Santo André
India9 sites
SB Investigative Site
Bangalore
SB Investigative Site
Bhubaneswar
SB Investigative Site
Erandwane
SB Investigative Site
Hyderabad
SB Investigative Site 1
Jaipur
SB Investigative Site 2
Jaipur
SB Investigative Site
Mumbai
SB Investigative Site
Sūrat
SB Investigative Site
Udaipur
Romania8 sites
SB Investigative Site
Cluj-Napoca
SB Investigative Site 1
Craiova
SB Investigative Site 2
Craiova
SB Investigative Site
Craiova
SB Investigative Site
Iași
SB Investigative Site
Oradea
SB Investigative Site
Sibiu
SB Investigative Site
Suceava
Georgia7 sites
SB Investigative Site
Batumi
SB Investigative Site 1
Tbilisi
SB Investigative Site 2
Tbilisi
SB Investigative Site 3
Tbilisi
SB Investigative Site 4
Tbilisi
SB Investigative Site 5
Tbilisi
SB Investigative Site 6
Tbilisi
Spain7 sites
SB Investigative Site
Leganés
SB Investigative Site
Málaga
SB Investigative Site
Ourense
SB Investigative Site
Oviedo
SB Investigative Site
Santiago de Compostela
SB Investigative Site
Seville
SB Investigative Site
Valencia
Malaysia6 sites
SB Investigative Site
George Town
SB Investigative Site
Johor Bahru
SB Investigative Site
Kota Bharu
SB Investigative Site
Kuantan
SB Investigative Site
Lembah Pantai
SB Investigative Site
Putrajaya
Philippines5 sites
SB Investigative Site
Davao City
SB Investigative Site
Makati City
SB Investigative Site
Manila
SB Investigative Site
Quezon City
SB Investigative Site
San Juan City
Serbia5 sites
SB Investigative Site 1
Belgrade
SB Investigative Site 2
Belgrade
SB Investigative Site
Kamenitz
SB Investigative Site
Kragujevac
SB Investigative Site
Niš
Germany4 sites
SB Investigative Site
Düsseldorf
SB Investigative Site
Halle
SB Investigative Site
Moers
SB Investigative Site
Neuss
Thailand4 sites
SB Investigative Site 1
Bangkok
SB Investigative Site 2
Bangkok
SB Investigative Site
Bangkok Noi
SB Investigative Site
Khon Kaen
Bosnia and Herzegovina3 sites
SB Investigative Site
Banja Luka
SB Investigative Site
Mostar
SB Investigative Site
Sarajevo
Mexico3 sites
SB Investigative Site
Aguascalientes
SB Investigative Site
Guadalajara
SB Investigative Site
Mexico City
About this study
Official title: A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:
- How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Being tested
- SB27, 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
KeytrudaDrug
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| SB27 | Experimental | SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). Receives: Drug: SB27 |
| Keytruda | Active comparator | Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). Receives: Drug: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) at Week 24
Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1
Measured: At Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start12 Mar 2024
- Primary completion10 Mar 2026
- Study completionAug 2027 (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 IVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 555 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
- NCT06348199
- Sponsor's protocol ID
- SB27-3004
- Status last verified
- Oct 2026
- First submitted
- 28 Mar 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 (Proposed Pembrolizumab Biosimilar) and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06348199
- Acronym / sponsor ID
- SB27-3004
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Apr 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 confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients. The main question it aims to answer is:
- How effective the study drug is Participants will receive either investigational product (SB27 or Keytruda) and chemotherapy every 3 weeks.
Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB27 | Experimental | Drug: SB27SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). |
| Keytruda | Active comparator | Drug: KeytrudaKeytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles). |
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 ≥ 18 years of age
- Have been diagnosed with stage IV non-squamous NSCLC
- Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
- Agree to use adequate methods of contraception
Key exclusion criteria (2 listed)
- Unable or unwilling to take folic acid and vitamin B12 supplementation
- Severe hypersensitivity to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
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 | Drug | SB27 |
| KeytrudaWill be administered intravenously at a fixed dose of 200 mg every 3 weeks | Drug | Keytruda |
Primary outcome
Objective response rate (ORR) at Week 24
Time frame: At Week 24
Defined as the proportion of subjects achieving a complete response (CR) or partial response (PR) at Week 24 according to RECIST v1.1
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 26 Oct 2026.
Related trials for Non-small Cell Lung Cancer Stage IV
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Non-small Cell Lung Cancer
RecruitingPhase 3
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, c-MET
RecruitingPhase 3
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
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.
93 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SB27 and Keytruda in people with Non-small Cell Lung Cancer Stage IV, run by Samsung Bioepis Co., Ltd. at 93 sites in 14 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in Turkey (Türkiye), Japan, Brazil, India, Romania and 9 more countries. 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?
Objective response rate (ORR) at Week 24 (time frame: At Week 24). 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 26 Oct 2026.