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Could a cheaper keytruda copy work just as well for lung cancer?

NCT ID NCT06687369

Disease control Sponsor: mAbxience Research S.L. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study compares a new, potentially more affordable drug called MB12 (a biosimilar to Keytruda) to the original Keytruda, both given with chemotherapy, as a first treatment for people with advanced stage IV non-squamous non-small cell lung cancer. About 726 adults who have not had prior treatment for metastatic lung cancer will participate. The goal is to see if MB12 is as safe and effective as Keytruda.

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

About 726 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Sep 2027

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: 1. Adult male/female patients ≥18 years old at the time of signing the informed consent form (ICF). 2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \[TNM\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required. 3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1. 4. Known status of PD-L1 expression. 5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function. Exclusion Criteria: 1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible. 2. Known history of central nervous system metastases and/or carcinomatous meningitis. 3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints). 4. Major surgery within 3 weeks of the first dose of study treatment. 5. Active autoimmune disease that has required systemic treatment in the last 2 years. 6. Contraindication and/or intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab. 7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.

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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-squamous non-small cell lung cancer

Contacts and locations

Locations

  • Research site 116001

    Chisinau, Moldova

  • Site 101001

    Yerevan, Armenia

  • Site 101002

    Yerevan, Armenia

  • Site 101003

    Yerevan, Armenia

  • Site 101004

    Yerevan, Armenia

  • Site 103001

    Sarajevo, Bosnia and Herzegovina

  • Site 103002

    Tuzla, Bosnia and Herzegovina

  • Site 103003

    Zenica, Bosnia and Herzegovina

  • Site 108001

    Tbilisi, Georgia

  • Site 108002

    Tbilisi, Georgia

  • Site 108003

    Tbilisi, Georgia

  • Site 108004

    Batumi, Georgia

  • Site 108005

    Kutaisi, Georgia

  • Site 108006

    Tbilisi, Georgia

  • Site 108007

    Tbilisi, Georgia

  • Site 108008

    Tbilisi, Georgia

  • Site 108009

    Tbilisi, Georgia

  • Site 108010

    Tbilisi, Georgia

  • Site 108011

    Marneuli, Georgia

  • Site 108012

    Tbilisi, Georgia

  • Site 110001

    Thessaloniki, Greece

  • Site 110002

    Thessaloniki, Greece

  • Site 110003

    Kifissia, Greece

  • Site 110004

    Larissa, Greece

  • Site 110005

    Thessaloniki, Greece

  • Site 110006

    Athens, Greece

  • Site 110008

    Thessaloniki, Greece

  • Site 110009

    Pátrai, Greece

  • Site 110010

    Volos, Greece

  • Site 112001

    Sfax, Tunisia

  • Site 112002

    Aryanah, Tunisia

  • Site 112003

    Aryanah, Tunisia

  • Site 112004

    Aryanah, Tunisia

  • Site 112005

    Tunis, Tunisia

  • Site 113001

    Pavia, Italy

  • Site 113003

    Roma, Italy

  • Site 113005

    Siena, Italy

  • Site 113006

    Roma, Italy

  • Site 113007

    Genova, Italy

  • Site 113008

    Torino, Italy

  • Site 113009

    Meldola, Italy

  • Site 113010

    Cremona, Italy

  • Site 113011

    Lecce, Italy

  • Site 113012

    Brescia, Italy

  • Site 114001

    Amman, Jordan

  • Site 114002

    Amman, Jordan

  • Site 114003

    Amman, Jordan

  • Site 114004

    Amman, Jordan

  • Site 114005

    Amman, Jordan

  • Site 114006

    Irbid, Jordan

  • Site 114007

    Amman, Jordan

  • Site 118001

    Lodz, Poland

  • Site 118002

    Prabuty, Poland

  • Site 118003

    Słupsk, Poland

  • Site 118004

    Katowice, Poland

  • Site 118005

    Lublin, Poland

  • Site 119001

    Lisbon, Portugal

  • Site 119002

    Matosinhos Municipality, Portugal

  • Site 119003

    Porto, Portugal

  • Site 120001

    Cluj-Napoca, Romania

  • Site 120003

    Craiova, Romania

  • Site 120004

    Craiova, Romania

  • Site 120005

    Timișoara, Romania

  • Site 120006

    Floreşti, Romania

  • Site 121001

    Belgrade, Serbia

  • Site 121002

    Belgrade, Serbia

  • Site 121003

    Kragujevac, Serbia

  • Site 121004

    Kamenitz, Serbia

  • Site 121005

    Užice, Serbia

  • Site 122001

    Bratislava, Slovakia

  • Site 122002

    Partizánske, Slovakia

  • Site 122003

    Bardejov, Slovakia

  • Site 123001

    Pretoria, South Africa

  • Site 123002

    Port Elizabeth, South Africa

  • Site 123003

    Pretoria, South Africa

  • Site 123004

    KwaZulu, South Africa

  • Site 123005

    Johannesburg, South Africa

  • Site 123006

    Johannesburg, South Africa

  • Site 123007

    Kraaifontein, South Africa

  • Site 124001

    Palma de Mallorca, Spain

  • Site 124002

    Barcelona, Spain

  • Site 124003

    Oviedo, Spain

  • Site 124004

    Seville, Spain

  • Site 124005

    Sant Joan Despí, Spain

  • Site 124006

    A Coruña, Spain

  • Site 124007

    Madrid, Spain

  • Site 124008

    Málaga, Spain

  • Site 124009

    Madrid, Spain

  • Site 124010

    Santiago de Compostela, Spain

  • Site 124011

    Madrid, Spain

  • Site 124012

    Madrid, Spain

  • Site 124013

    Barcelona, Spain

  • Site 124014

    Pontevedra, Spain

  • Site 124015

    Valencia, Spain

  • Site 124016

    Murcia, Spain

  • Site 125001

    Ankara, Turkey (Türkiye)

  • Site 125002

    Ankara, Turkey (Türkiye)

  • Site 125003

    Istanbul, Turkey (Türkiye)

  • Site 125004

    Ankara, Turkey (Türkiye)

  • Site 125006

    Alanya, Turkey (Türkiye)

  • Site 125007

    Tekirdağ, Turkey (Türkiye)

  • Site 125008

    Ankara, Turkey (Türkiye)

  • Site 125009

    Ankara, Turkey (Türkiye)

  • Site 125010

    Istanbul, Turkey (Türkiye)

  • Site 125011

    Istanbul, Turkey (Türkiye)

  • Site 125012

    Istanbul, Turkey (Türkiye)

  • Site 125013

    Samsun, Turkey (Türkiye)

  • Site 125014

    Yüreğir, Turkey (Türkiye)

  • Site 125015

    Izmir, Turkey (Türkiye)

  • Site 125017

    Adana, Turkey (Türkiye)

  • Site 125018

    Istanbul, Turkey (Türkiye)

  • Site 125019

    Ankara, Turkey (Türkiye)

  • Site 125023

    Sakarya, Turkey (Türkiye)

  • Site 202001

    Cheras, Malaysia

  • Site 202002

    Kota Bharu, Malaysia

  • Site 202003

    Kuala Selangor, Malaysia

  • Site 203002

    Quezon City, Philippines

  • Site 203003

    Baguio City, Philippines

  • Site 203004

    Iloilo City, Philippines

  • Site 203005

    Makati City, Philippines

  • Site 203006

    Bacolod City, Philippines

  • Site 203007

    Manila, Philippines

  • Site 203009

    Iloilo City, Philippines

  • Site 204001

    Incheon, South Korea

  • Site 204002

    Seoul, South Korea

  • Site 204004

    Gyeonggi-do, South Korea

  • Site 204005

    Busan, South Korea

  • Site 204006

    Gyeonggi-do, South Korea

  • Site 204007

    Seoul, South Korea

  • Site 205002

    Taichung, Taiwan

  • Site 205003

    Kaohsiung City, Taiwan

  • Site 205004

    Liuying, Taiwan

  • Site 205005

    Tainan, Taiwan

  • Site 205006

    Taipei, Taiwan

  • Site 205007

    Taipei, Taiwan

  • Site 205008

    Taichung, Taiwan

  • Site 205009

    Kaohsiung City, Taiwan

  • Site 206001

    Chiang Mai, Thailand

  • Site 206002

    Nakhon Nayok, Thailand

  • Site 206003

    Khon Kaen, Thailand

  • Site 206004

    Bangkok, Thailand

  • Site 206005

    Bangkok, Thailand

  • Site 206006

    Songkhla, Thailand

  • Site 206007

    Chiang Rai, Thailand

  • Site 207001

    Shizuoka, Japan

  • Site 207002

    Hakodate-shi, Japan

  • Site 207010

    Shinagawa-Ku, Japan

  • Site 207012

    Okayama, Japan

  • Site 301001

    São José do Rio Preto, Brazil

  • Site 301002

    Belo Horizonte, Brazil

  • Site 301003

    Porto Alegre, Brazil

  • Site 301005

    Porto Alegre, Brazil

  • Site 301006

    Blumenau, Brazil

  • Site 301007

    Porto Alegre, Brazil

  • Site 301008

    Itajaí, Brazil

  • Site 301009

    Rio de Janeiro, Brazil

  • Site 301010

    Fortaleza, Brazil

  • Site 301011

    Ijuí, Brazil

  • Site 301012

    Jaú, Brazil

  • Site 301014

    Barretos, Brazil

  • Site 301015

    Curitiba, Brazil

  • Site 301016

    Porto Alegre, Brazil

  • Site 301018

    Natal, Brazil

  • Site 301019

    Caxias do Sul, Brazil

  • Site 301020

    Santo André, Brazil

  • Site 301022

    Recife, Brazil

  • Site 301023

    Bento Gonçalves, Brazil

  • Site 301024

    Florianópolis, Brazil

  • Site 301026

    Belém, Brazil

  • Site 301028

    Curitiba, Brazil

  • Site 304001

    Panama City, Panama

  • Site 304002

    Panama City, Panama

  • Site 304003

    Panama City, Panama

More trials for these conditions

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