A Phase 1 interventional study of SB27 and EU sourced Keytruda in Non-small Cell Lung Cancer Stage II and Non-small Cell Lung Cancer Stage IIIA, sponsored by Samsung Bioepis Co., Ltd.. Active, not recruiting at 24 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 1, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of — 123 open to participants now, 264 under way, 101 of them phase 3. Carcinoma, Non-Small-Cell Lung · Korea, Republic of.
Among the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of, this one is the 374th largest by enrollment of the 657 interventional ones that give a count, is one of 55 that started in 2024, is one of 110 in phase 1, reaches primary completion later than 64 of the 263 other live ones, and was the 600th registered.
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 →123 of the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Txinno Bioscience Inc. · Sites in Korea, Republic of
Ages 19+
Hoffmann-La Roche · Sites in Korea, Republic of, United States, Argentina and 16 more countries
Ages 18+
Eun Hye Lee · Sites in Korea, Republic of
Ages 19+
Bristol-Myers Squibb · Sites in Korea, Republic of, United States, Argentina and 13 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Korea, Republic of, United States, Canada and 3 more countries
Ages 18+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
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 →This tab as a report to print or save as PDF → With an account.
700 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 194 · Phase 2 313 · Phase 3 232 · Phase 4 6
First in 1994; this study’s year is marked. 55 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 163 is above the median of 62 across 6,020 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 200 across the 657 interventional studies, 339 across the 39 observational. Of the 373 that completed or were terminated, 230 (62%) have results posted.
This tab as a report to print or save as PDF → With an account.
571 of 700 have an industry lead sponsor. The 10 most frequent:
Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Samsung Bioepis Co., Ltd. has 3 studies filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
64 of the studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of that are under way reach primary completion within a year, 18 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT06430866Phase 3AmgenPharmacokinetic Similarity Between ABP 234 and Keytruda® (Pembrolizumab) | 2026-12-14 |
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
| NCT05609968Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46) | 2027-01-12 |
Add all 64 to your calendar (.ics) → With an account.
Among the 700 studies in Carcinoma, Non-Small-Cell Lung with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
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.
Exclusion Criteria:
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SB27 will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Drug: SB27
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Drug: EU sourced Keytruda
EU sourced Keytruda will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Drug: US sourced Keytruda
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
Will be administered intravenously at a fixed dose of 200 mg every 3 weeks, maximum 18 cycles over about 51 weeks
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
Time frame: 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
Time frame: At the end of Cycle 6 (each cycle is 21 days)
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.
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
Defined as the time from the date of randomization until the date of death of any cause.
Time frame: From the date of randomization until the date of death of any cause, assessed up to Week 55
Ran from Jan 2024 to primary completion in Feb 2026, 25 months.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's 25 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carcinoma, Non-Small-Cell Lung →