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Cheaper keytruda alternative tested in lung cancer trial

NCT ID NCT06159790

Disease control Sponsor: Sandoz 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tested GME751, a biosimilar (copy) of the immunotherapy drug Keytruda, against the original Keytruda in 218 adults with untreated advanced non-squamous lung cancer. The goal was to see if GME751 works as well and is as safe as Keytruda when combined with chemotherapy. The study is complete, and results will show if this biosimilar could be a more affordable treatment option.

What this could mean

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

Active substance
GME751 (a biosimilar of pembrolizumab, also known as Keytruda)
What this could lead to
If successful, this could provide a more affordable alternative to Keytruda for treating advanced lung cancer, potentially expanding access to effective immunotherapy.
What could go wrong
This is a biosimilar, not a new drug, so it may not offer better outcomes than the original. The trial is completed but results are not yet widely available, and individual responses may vary.

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

218 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

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: * At least 18 years of age * Untreated metastatic NSCLC * Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements * Measurable disease according to RECIST 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: * Squamous cell or mixed histology in NSCLC * Known history of hypersensitivity (grade ≥3) to pembrolizumab, chemotherapy or their excipients * Active autoimmune disease that has required chronic systemic treatment in the past 2 years. * Received live vaccine ≤30 days before the first study treatment * Prior treatment with pembrolizumab or any other anti-PD-1, or anti-PD-L1 or anti-PD-L2, or anti-CTLA-4 agent or any antibody targeting other immune-regulatory receptors or mechanisms for lung cancer. Other protocol-defined inclusion/exclusion criteria apply.

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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.

Metastatic NSCLC

Contacts and locations

Locations

  • Sandoz Investigational Site

    Fountain Valley, California, 92708, United States

  • Sandoz Investigational Site

    Banja Luka, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Sarajevo, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Zenica, Bosnia and Herzegovina

  • Sandoz Investigational Site

    Belo Horizonte, Brazil

  • Sandoz Investigational Site

    Fortaleza, Brazil

  • Sandoz Investigational Site

    Ipatinga, Brazil

  • Sandoz Investigational Site

    Porto Alegre, Brazil

  • Sandoz Investigational Site

    São José do Rio Preto, Brazil

  • Sandoz Investigational Site

    Batumi, Georgia

  • Sandoz Investigational Site

    Tbilisi, Georgia

  • Sandoz Investigational Site

    Rosenheim, Germany

  • Sandoz Investigational Site

    Ahmedabad, India

  • Sandoz Investigational Site

    Bhubaneswar, India

  • Sandoz Investigational Site

    Hyderabad, India

  • Sandoz Investigational Site

    Mumbai, India

  • Sandoz Investigational Site

    Nagpur, India

  • Sandoz Investigational Site

    Nashik, India

  • Sandoz Investigational Site

    New Delhi, India

  • Sandoz Investigational Site

    Varanasi, India

  • Sandoz Investigational Site

    Asahikawa, Japan

  • Sandoz Investigational Site

    Funabashi, Japan

  • Sandoz Investigational Site

    Hiroshima, Japan

  • Sandoz Investigational Site

    Kanazawa, Japan

  • Sandoz Investigational Site

    Niigata, Japan

  • Sandoz Investigational Site

    Okayama, Japan

  • Sandoz Investigational Site

    Sapporo, Japan

  • Sandoz Investigational Site

    Johor Bahru, Malaysia

  • Sandoz Investigational Site

    Kuala Lumpur, Malaysia

  • Sandoz Investigational Site

    Kuantan, Malaysia

  • Sandoz Investigational Site

    Kuching, Malaysia

  • Sandoz Investigational Site

    Malacca, Malaysia

  • Sandoz Investigational Site

    Petaling Jaya, Malaysia

  • Sandoz Investigational Site

    Putrajaya, Malaysia

  • Sandoz Investigational Site

    Bacolod, Philippines

  • Sandoz Investigational Site

    Cebu City, Philippines

  • Sandoz Investigational Site

    Makati, Philippines

  • Sandoz Investigational Site

    Cluj-Napoca, Romania

  • Sandoz Investigational Site

    Floreşti, Romania

  • Sandoz Investigational Site

    Kragujevac, Serbia

  • Sandoz Investigational Site

    A Coruña, Spain

  • Sandoz Investigational Site

    Córdoba, Spain

  • Sandoz Investigational Site

    Madrid, Spain

  • Sandoz Investigational Site

    Oviedo, Spain

  • Sandoz Investigational Site

    Douliu, Taiwan

  • Sandoz Investigational Site

    Kaohsiung City, Taiwan

  • Sandoz Investigational Site

    Taichung, Taiwan

  • Sandoz Investigational Site

    Taipei, Taiwan

  • Sandoz Investigational Site

    Bangkok, Thailand

  • Sandoz Investigational Site

    Khon Kaen, Thailand

  • Sandoz Investigational Site

    Adana, Turkey (Türkiye)

  • Sandoz Investigational Site

    Bursa, Turkey (Türkiye)

  • Sandoz Investigational Site

    Gaziantep, Turkey (Türkiye)

  • Sandoz Investigational Site

    Istanbul, Turkey (Türkiye)

  • Sandoz Investigational Site

    Malatya, Turkey (Türkiye)

  • Sandoz Investigational Site

    Sakarya, Turkey (Türkiye)

  • Sandoz Investigational Site

    Yüreğir, Turkey (Türkiye)

  • Sandoz Investigational Site

    Hanoi, Vietnam

  • Sandoz Investigational Site

    Hà Nội, Vietnam

  • Sandoz Investigational Site

    Ho Chi Minh City, Vietnam

  • Sandoz Investigational Site 2

    Ahmedabad, India

  • Sandoz Investigational Site 2

    Mumbai, India

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