ClinicalTrials.gg
Active, not recruitingNCT06348199Updated Oct 26, 2026

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 interventional study of SB27 and Keytruda in Non-small Cell Lung Cancer Stage IV, sponsored by Samsung Bioepis Co., Ltd.. Active, not recruiting at 93 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Samsung Bioepis Co., Ltd. · Phase 3, Interventional, and Treatment

Updated Oct 26, 2026Study completion movedGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
555
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 255 studies in Carcinoma, Non-Small-Cell Lung with a site in Turkey — 62 open to participants now, 145 under way, 94 of them phase 3. Carcinoma, Non-Small-Cell Lung · Turkey.

Enrollment
106th of 242
555 · median 413
Started
2024
with 31 others
Phase 3
157 of 255
33 open now
Primary completion
2026-03
later than 34 of 144 live
Registered
189th of 255
by date

Among the 255 studies in Carcinoma, Non-Small-Cell Lung with a site in Turkey, this one is the 106th largest by enrollment of the 242 interventional ones that give a count, is one of 32 that started in 2024, is one of 157 in phase 3, reaches primary completion later than 34 of the 144 other live ones, and was the 189th registered.

Carcinoma, Non-Small-Cell Lung

7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,836 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

62 of the 255 studies in Carcinoma, Non-Small-Cell Lung with a site in Turkey are open now. Recruiting first, the newest first:

57 more — sign in →

All 62 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 1,327 Carcinoma, Non-Small-Cell Lung studies recruiting now, 989 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 255 studies in Carcinoma, Non-Small-Cell Lung with a site in Turkey, or all of them as a file.
02

Study 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 chemotherapy every 3 weeks.

Researchers will compare SB27 and Keytruda to see if SB27 works in the same way as Keytruda.

03

Conditions studied

  • Non-small Cell Lung Cancer Stage IV
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 NSCLC
  • Agree to use adequate methods of

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to take folic acid and vitamin B12 supplementation
  • Severe to treatment with another monoclonal antibody, any ingredient contained in SB27 or Keytruda, or any component of platinum-containing compounds or pemetrexed.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
555 participants (actual)

Study arms

  • Experimental
    SB27

    SB27 will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

    Drug: SB27

  • Active comparator
    Keytruda

    Keytruda will be administered followed by Pemetrexed and Carboplatin (Carboplatin will be administered for the first 4 cycles).

    Drug: Keytruda

Interventions

  • DrugSB27

    Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

  • Will be administered intravenously at a fixed dose of 200 mg every 3 weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At Week 24

07

Study locations

93 sites
  • SB Investigative Site
    Banja Luka, Bosnia and Herzegovina
  • SB Investigative Site
    Mostar, Bosnia and Herzegovina
  • SB Investigative Site
    Sarajevo, Bosnia and Herzegovina
  • SB Investigative Site
    Curitiba, Brazil
  • SB Investigative Site
    Florianópolis, Brazil
  • SB Investigative Site
    Ijuí, Brazil
  • SB Investigative Site
    Natal, Brazil
  • SB Investigative Site
    Pelotas, Brazil
  • SB Investigative Site 1
    Porto Alegre, Brazil
  • SB Investigative Site 2
    Porto Alegre, Brazil
  • SB Investigative Site
    Rio de Janeiro, Brazil
  • SB Investigative Site
    Santo André, Brazil
  • SB Investigative Site
    Batumi, Georgia
  • SB Investigative Site 1
    Tbilisi, Georgia
  • SB Investigative Site 2
    Tbilisi, Georgia
  • SB Investigative Site 3
    Tbilisi, Georgia
  • SB Investigative Site 4
    Tbilisi, Georgia
  • SB Investigative Site 5
    Tbilisi, Georgia
  • SB Investigative Site 6
    Tbilisi, Georgia
  • SB Investigative Site
    Düsseldorf, Germany
  • SB Investigative Site
    Halle, Germany
  • SB Investigative Site
    Moers, Germany
  • SB Investigative Site
    Neuss, Germany
  • SB Investigative Site
    Bangalore, India
  • SB Investigative Site
    Bhubaneswar, India
  • SB Investigative Site
    Erandwane, India
  • SB Investigative Site
    Hyderabad, India
  • SB Investigative Site 1
    Jaipur, India
  • SB Investigative Site 2
    Jaipur, India
  • SB Investigative Site
    Mumbai, India
  • SB Investigative Site
    Sūrat, India
  • SB Investigative Site
    Udaipur, India
  • SB Investigative Site
    Himeji, Japan
  • SB Investigative Site
    Iwakuni, Japan
  • SB Investigative Site
    Izumi, Japan
  • SB Investigative Site
    Kawachi-Nagano, Japan
  • SB Investigative Site
    Kobe, Japan
  • SB Investigative Site
    Kochi, Japan
  • SB Investigative Site
    Sagamihara, Japan
  • SB Investigative Site
    Tachikawa, Japan
  • SB Investigative Site
    Takarazuka, Japan
  • SB Investigative Site
    Toyonaka, Japan
  • SB Investigative Site
    George Town, Malaysia
  • SB Investigative Site
    Johor Bahru, Malaysia
  • SB Investigative Site
    Kota Bharu, Malaysia
  • SB Investigative Site
    Kuantan, Malaysia
  • SB Investigative Site
    Lembah Pantai, Malaysia
  • SB Investigative Site
    Putrajaya, Malaysia
  • SB Investigative Site
    Aguascalientes, Mexico
  • SB Investigative Site
    Guadalajara, Mexico
  • SB Investigative Site
    Mexico City, Mexico
  • SB Investigative Site
    Davao City, Philippines
  • SB Investigative Site
    Makati City, Philippines
  • SB Investigative Site
    Manila, Philippines
  • SB Investigative Site
    Quezon City, Philippines
  • SB Investigative Site
    San Juan City, Philippines
  • SB Investigative Site
    Cluj-Napoca, Romania
  • SB Investigative Site 1
    Craiova, Romania
  • SB Investigative Site 2
    Craiova, Romania
  • SB Investigative Site
    Craiova, Romania
  • SB Investigative Site
    Iași, Romania
  • SB Investigative Site
    Oradea, Romania
  • SB Investigative Site
    Sibiu, Romania
  • SB Investigative Site
    Suceava, Romania
  • SB Investigative Site 1
    Belgrade, Serbia
  • SB Investigative Site 2
    Belgrade, Serbia
  • SB Investigative Site
    Kamenitz, Serbia
  • SB Investigative Site
    Kragujevac, Serbia
  • SB Investigative Site
    Niš, Serbia
  • SB Investigative Site
    Leganés, Spain
  • SB Investigative Site
    Málaga, Spain
  • SB Investigative Site
    Ourense, Spain
  • SB Investigative Site
    Oviedo, Spain
  • SB Investigative Site
    Santiago de Compostela, Spain
  • SB Investigative Site
    Seville, Spain
  • SB Investigative Site
    Valencia, Spain
  • SB Investigative Site 1
    Bangkok, Thailand
  • SB Investigative Site 2
    Bangkok, Thailand
  • SB Investigative Site
    Bangkok Noi, Thailand
  • SB Investigative Site
    Khon Kaen, Thailand
  • SB Investigative Site
    Adapazarı, Turkey (Türkiye)
  • SB Investigative Site 1
    Ankara, Turkey (Türkiye)
  • SB Investigative Site 2
    Ankara, Turkey (Türkiye)
  • SB Investigative Site
    Bağcılar, Turkey (Türkiye)
  • SB Investigative Site
    Balgat, Turkey (Türkiye)
  • SB Investigative Site
    Çubuk, Turkey (Türkiye)
  • SB Investigative Site
    Istanbul, Turkey (Türkiye)
  • SB Investigative Site
    İzmit, Turkey (Türkiye)
  • SB Investigative Site
    Kavaklıdere, Turkey (Türkiye)
  • SB Investigative Site
    Konak, Turkey (Türkiye)
  • SB Investigative Site
    Maltepe, Turkey (Türkiye)
  • SB Investigative Site
    Seyhan, Turkey (Türkiye)
  • SB Investigative Site
    Sivas, Turkey (Türkiye)
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Mar 2026, 23 months.

Of 315 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's 23 months is below that.

Counting every sponsor, half of 424 studies reached it within 45 months; a quarter within 30 and three quarters within 69.

Completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Aug 2027, on Oct 26, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2024
First posted
Apr 4, 2024
StartActual
Mar 12, 2024
Primary completionActual
Mar 10, 2026
CompletionEst.
Aug 2027was Sep 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Sep 2026→Aug 2027
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Study completion Sep 2026→Aug 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06348199
Responsible party
Sponsor
First posted
Apr 4, 2024
Start date
Mar 12, 2024
Primary completion
Mar 10, 2026
Completion
Aug 2027 (estimated)
Last update
Oct 26, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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