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Could a cheaper keytruda copy work for lung cancer?

NCT ID NCT06268613

Disease control Sponsor: Samsung Bioepis Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial compares a biosimilar drug (SB27) to the standard cancer immunotherapy Keytruda in 163 people with stage II-IIIA non-small cell lung cancer who have already had surgery and chemotherapy. The main goal is to see if the body processes SB27 the same way as Keytruda. If successful, SB27 could become a more affordable alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (a biosimilar version of Keytruda)
What this could lead to
If SB27 works like Keytruda, it could offer a more affordable treatment option for early-stage lung cancer after surgery.
What could go wrong
This is an early phase 1 trial focused on drug levels in the blood, not yet on long-term outcomes. The biosimilar may not prove equally effective or safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

163 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Have received anti-cancer therapy before surgery * Have or had autoimmune disease in past 5 years

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer stage II Non-small cell lung cancer stage IIIA

Contacts and locations

Locations

  • SB Investigative Site

    Gdansk, Poland

  • SB Investigative Site

    Otwock, Poland

  • SB Investigative Site

    Ansan, South Korea

  • SB Investigative Site

    Busan, South Korea

  • SB Investigative Site

    Daegu, South Korea

  • SB Investigative Site

    Hwasun, South Korea

  • SB Investigative Site

    Incheon, South Korea

  • SB Investigative Site

    Jinju, South Korea

  • SB Investigative Site

    Seongnam, South Korea

  • SB Investigative Site

    Ulsan, South Korea

  • SB Investigative Site

    Jaén, Jaén, Spain

  • SB Investigative Site

    A Coruña, Santiago de Compostela, Spain

  • SB Investigative Site

    Málaga, Spain

  • SB Investigative Site

    Adana, Turkey (Türkiye)

  • SB Investigative Site

    Istanbul, Turkey (Türkiye)

  • SB Investigative Site

    Izmir, Turkey (Türkiye)

  • SB Investigative Site 1

    Suwon, South Korea

  • SB Investigative Site 1

    Ankara, Turkey (Türkiye)

  • SB Investigative Site 2

    Suwon, South Korea

  • SB Investigative Site 2

    Ankara, Turkey (Türkiye)

  • SB Investigative Site 3

    Seoul, South Korea

  • SB Investigative Site 4

    Seoul, South Korea

  • SB Investigative Site 5

    Seoul, South Korea

  • SB Investigative Site 6

    Seoul, South Korea

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