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Cheaper keytruda? new biosimilar SB27 tested in lung cancer

NCT ID NCT06348199

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether SB27, a proposed biosimilar to the cancer drug Keytruda, works as well as the original in people with advanced non-squamous non-small cell lung cancer. About 555 participants will receive either SB27 or Keytruda plus chemotherapy every 3 weeks. The main goal is to compare tumor shrinkage rates at 24 weeks.

What this could mean

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

Active substance
SB27 (a proposed biosimilar to pembrolizumab, the drug in Keytruda)
What this could lead to
If SB27 works as well as Keytruda, it could offer a more affordable treatment option for advanced lung cancer patients.
What could go wrong
This is a biosimilar study, not a new drug. Even if SB27 matches Keytruda, it may not improve outcomes. The trial is still ongoing, and results are not yet available.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

555 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Sep 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 ≥ 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • 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

    Rio de Janeiro, Brazil

  • SB Investigative Site

    Santo André, Brazil

  • SB Investigative Site

    Batumi, 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

    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

    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

    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

    Bangkok Noi, Thailand

  • SB Investigative Site

    Khon Kaen, Thailand

  • SB Investigative Site

    Adapazarı, 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)

  • SB Investigative Site 1

    Porto Alegre, Brazil

  • SB Investigative Site 1

    Tbilisi, Georgia

  • SB Investigative Site 1

    Jaipur, India

  • SB Investigative Site 1

    Craiova, Romania

  • SB Investigative Site 1

    Belgrade, Serbia

  • SB Investigative Site 1

    Bangkok, Thailand

  • SB Investigative Site 1

    Ankara, Turkey (Türkiye)

  • SB Investigative Site 2

    Porto Alegre, Brazil

  • SB Investigative Site 2

    Tbilisi, Georgia

  • SB Investigative Site 2

    Jaipur, India

  • SB Investigative Site 2

    Craiova, Romania

  • SB Investigative Site 2

    Belgrade, Serbia

  • SB Investigative Site 2

    Bangkok, Thailand

  • SB Investigative Site 2

    Ankara, Turkey (Türkiye)

  • SB Investigative Site 3

    Tbilisi, Georgia

  • SB Investigative Site 4

    Tbilisi, Georgia

  • SB Investigative Site 5

    Tbilisi, Georgia

  • SB Investigative Site 6

    Tbilisi, Georgia

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Other studies related to the condition(s) this trial covers.