#1 Clinical Trials Search in Europe

Study of Pembrolizumab for Patients with Early Stage Non-Small Cell Lung Cancer After Surgery and Standard Therapy

3 1 1

What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC), specifically in its early stages, which are referred to as Stage IB, II, and IIIA. The study is investigating the effects of a treatment called pembrolizumab, also known by its code name MK-3475, compared to a placebo. Pembrolizumab is a type of medication known as an anti-PD-1 monoclonal antibody, which is designed to help the immune system fight cancer cells.

The purpose of the study is to determine if pembrolizumab can improve the time patients remain free from cancer after they have undergone surgery and completed standard therapy. Participants in the study will receive either pembrolizumab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 52 weeks, during which participants will be monitored regularly to assess their health and the effectiveness of the treatment.

This trial is particularly interested in patients who have had their lung cancer surgically removed and have completed any additional recommended treatments. The study aims to see if pembrolizumab can help prevent the cancer from returning, especially in patients whose tumors show a strong presence of a protein called PD-L1. Participants will be closely observed by healthcare professionals throughout the study to ensure their safety and to gather important information about the treatment’s impact on their health.

1 registration

Provide written consent for tumor testing. This is necessary before joining the study.

Ensure no chronic use of immunosuppressive agents or systemic corticosteroids in the last 3 days before the first infusion.

Confirm stage IB (T ≥ 4 cm), II, or IIIA non-small cell lung cancer (NSCLC) after complete surgical removal of the tumor.

Submit a tumor sample for PD-L1 testing. This is required for participation, although the level of PD-L1 does not affect eligibility.

2 central confirmation of PD-L1 status

PD-L1 status must be confirmed through a central process. This is necessary to proceed to the next step.

3 randomization

Provide written consent for participation in the main study.

Ensure no evidence of disease through clinical examination and imaging tests within 12 weeks before randomization.

Adjuvant chemotherapy is optional but recommended for certain stages. If received, it must be completed within specific timeframes relative to surgery and randomization.

Ensure no history of certain lung diseases or active autoimmune diseases requiring treatment in the past 2 years.

Confirm adequate organ function and absence of severe comorbidities that could affect participation.

4 treatment administration

Receive pembrolizumab or placebo intravenously. The specific dosage and frequency will be determined by the study protocol.

Continue treatment as per the study schedule, monitoring for any side effects or changes in health status.

5 follow-up

Undergo regular health assessments to monitor disease status and any potential side effects of the treatment.

Participate in follow-up visits as scheduled by the study protocol to ensure ongoing evaluation of health and treatment efficacy.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must have a confirmed diagnosis of NSCLC (Non-Small Cell Lung Cancer) at specific stages (IB, II, or IIIA) after complete surgical removal of the tumor.
  • Must provide a tumor sample for testing a protein called PD-L1.
  • Must have no signs of disease based on recent medical exams and scans.
  • Must not have a history of certain lung diseases or active autoimmune diseases that required treatment in the past 2 years.
  • Must not have had another type of cancer unless it has been in remission for at least 5 years, with some exceptions like certain skin cancers.
  • Must not have had a tissue or organ transplant.
  • Must not have any active infections that need treatment.
  • Must not have any unresolved side effects from previous surgery or chemotherapy, except for hair loss, tiredness, nerve pain, or loss of appetite.
  • Female patients who can have children must have a negative pregnancy test and agree to use two forms of birth control during the study and for a period after.
  • Male patients with partners who can have children must agree to use two forms of birth control during the study and for a period after.
  • Female patients who are breastfeeding must stop nursing before starting the study treatment and for a period after.
  • Must have adequate organ function based on recent tests.
  • Must not have had certain treatments like radiotherapy or specific immune therapies for the current cancer.
  • Must not be participating in another clinical trial or using experimental treatments recently.
  • Must not have a known history of HIV or active Hepatitis B or C.

Who Cannot Join the Study?

  • Patients who have not completed radical surgery, which means a major operation to remove lung cancer, cannot participate.
  • Patients who have not had a lobectomy or pneumonectomy, which are types of lung surgeries, are excluded.
  • Patients who have not received or completed standard adjuvant chemotherapy, which is additional cancer treatment given after surgery, are not eligible.
  • Patients who do not have Stage IB (T ≥ 4 cm), II, or IIIA NSCLC, which are specific stages of non-small cell lung cancer, cannot join the study.
  • Patients who are not in the PDL1 strong positive subgroup or the overall population, which refers to specific groups based on a protein that can affect cancer treatment, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Koranyi National Institute For Pulmonology Budapest Hungary
Haemato-Onkologie Hamburg – Prof. Laack und Partner Hamburg Germany
Universitaetsmedizin Goettingen Goettingen Germany
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy

Other Sites

Site Name City Country Status
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Centre Francois Baclesse Caen France
Saarland University Hospital Homburg Germany
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
University Medical Center Ljubljana Ljubljana Slovenia
University Hospital Olomouc Olomouc Czechia
Cabinet Medical Van Houte Cornejo Montero Yvoir Belgium
University Hospital Limerick Limerick Ireland
Fakultni Nemocnice Bulovka Prague Czechia
Isovuedw Jdprd Bfroqo Anderlecht Belgium
Udoqqtfzkc Od Dydvnfbg Debrecen Hungary
Lniqv Gffjvvq Hxqtgari Ot Arfoxt Athens Greece
Hanponju Vmrb dvulzpfc Barcelona Spain
Nrplp Enwjlre Mybvhpb Ctelja Fmzfivlhhj Tallin Estonia
Vmoxxl dxi Rjzdq Uwryvzabgg Hnzdxpvb Sevilla Spain
Fnfeixor nxjymezro Mwewh a Hjvjium Prague Czechia
Omeryu Uxqxhbonli Hewhbqvn Odense Denmark
Hxzlcq Hbovenzs Herlev Denmark
Hldhoptf Crtpjd Dr Bfetpzvny Barcelona Spain
Cktlsgh Udfwncksjudqfsjcukyf Bismxs Kdu Berlin Germany
Iyroq Ouwdpdha Peskuheumme Slz Modqfoy Genoa Italy
Cuccjl Hdjgutjzgh E Upudcnoexklti Dw Culeusf Etmcff Coimbra Portugal
Gmwpxph Ujlvylxbfj Hydolhpy Ok Paxzng Patras Greece
Cwkkah Hpzmfisupav Uldndbfljvcws Dg Rniobo Rennes France
Anjfmke Ucqwn Sxrcucosr Lwqkdy De Bvlduda Bologna Italy
Czdgpr Hqralsxyxq Usvssteivshnj Ds Sqzvq Aczggam Euyfvc Porto Portugal
Utikdgltnh Om Acyptsg Edegem Belgium
Awcaipcyn Kblcjw Givvawr Gzfq Gauting Germany
Uftkigkjahgfejotcnptk Sqcvihcbydwxvhbueb Ayb Kiel Germany
Auoavxl Sxccaoixe Uahjnwvuhumsw Fqnauk Ccalxoii Udine Italy
Cjfrnn Hbbdcudhapt Lzzu Sfj Pierre Benite France
Hhbmezcc Uiucfhdyfydwc Piksbv Di Hhxdgq Dc Mzvctgijlii Majadahonda Spain
Hxthewqa Uuytkgkrawpko 1n Dk Ofaxzir Madrid Spain
Aisoaxei Zvbqexuvpc Dvyis Roeselare Belgium
Fswynrjuu Parm Ly Iujiqxvbtvfbg Bbhehjmux Dgo Hxazbncw Uhknhvwlqwjnh Lf Prs Madrid Spain
Gqkrln Nevkxaxjtx Trvdmkhhuwwci Glyrdx Pnwuxxbnkruz Thessaloniki Greece
Hppcebtl Caxjwyk Uqdaleksubnvt Lakvdv Btjyo Zaragoza Spain
Ucvbbfhhrt Ghjbebd Hjxrjndu Ot Hhewbxdcb Heraklion Greece
Frjopgipxi Ijaas Sdl Gpzvlqr Dok Tocgrrg Monza Italy
Fsqnyvqift Icscllxopv Igiebway Ntxtxkzglrv Bwgqr Milan Italy
Hfzvmlcu Ubzztdhsadglh Vdeset Dr Li Vffjkcxa Malaga Spain
Ufkqmnwpqwu Swmmrrtf Salzburg Austria
Iswcxxlp Oxzsswzhiq Vfowfx Padua Italy
Pmdds Sxxuykue Cpdfdxnb Ukemclgymq Hhfbtjdm Riga Latvia
Fogpdvvr Nohrcslgf Phfez Plzen Czechia
Ftkyaqbsufjh Tdwvduizcgwgjklx Farkasgyepu Hungary
Oekgkzov Ozbzqlmlte Irgauqn Budapest Hungary
Cutycw dmyvtdvdwljmivyjk dc Prtq Bxnuzn Bayonne France
Uupqxbvcfm Cbwfyq Gqiewk Golnik Slovenia
Fzigvjjm Tnfffoitykj ntuniebgx Prague Czechia
Tbfnw Uajspzgrdb Hrjdsxac Tartu Estonia
San Ebyomjudu Hfyxxqty Tlniwud Tilburg The Netherlands
Rzedi Amjghvtu kwmllquo uvcqooytecgko srmlddpg Sdb Riga Latvia
Kbqrsamuefpwrj Dpnfmjbg Duesseldorf Germany
Hdbdjlot Uaampzfduqrub Voqgyb De Vkoob Sevilla Spain
Npiztrnh Irhrfjza Odcbngcre Ild Mweem Smgkhmaqljwrdgskgjrgnpyjqlif Ieoicqqj Bcrggyaj Cracow Poland
Ghynsj Uhqclsoyry Fyqfczfea Frankfurt Germany
Wcqajkwsscqxk Cfjxdib Pjysoswqtjol I Tvfmkhkiqkkvvbc Iwc Ezwmdza I Jexjuty Zmcrjltzr Poznan Poland
Admnebn Uweny Spingonzl Lsmich Dbnsu Rutjrsq Faenza Italy
Arfldzx Ouuwhnbnxse Uhzmoztiijdov Palbn Parma Italy
Cvm Gdnuhancrlfzxpnq Clermont Ferrand France
Rtjamk Batxx Keshvotrscd Gzjn Stuttgart Germany
Rajyppqqy Zxuqzleont Sbkaskbtn Arnhem The Netherlands
Vmhqslgs Nhestldo fpuk Gynpvriqjs Gisf Berlin Germany
Nxnlxrn Htctoxen Næstved Denmark
Nwbomlmlh Aomt Olzbouhdalpixyjzj amxe Ostrava Czechia
Cqim Umremwavwu Hmcssgra Cork Ireland
Urgkgcm Liysq Dc Swwnp Dw Ganlwupkjqax Eerrqr Vila Nova De Gaia Portugal
Gecpn Hlqvvsj Dq Clumdyhhe Charleroi Belgium
Uvlbnleknn Huzipapr Whtlqvgue Waterford Ireland
Ksjxiwooqtuwrwezu Vpejkoapx Stvmu Bpxqlqx Katlry Tatabanya Hungary
Eedxpjhecpld Lyxamupstsww Bovibv Kdrntpgzdiabpnukicv gyxdr Berlin Germany
Zrovsojgsj Sr Jjrtaze Harderwijk The Netherlands
Mgyjrmewhgo Cyreixw Ljilieac Cptitu Pntl I Gjtgfnci Otwock Poland
Lrhdpqcidcnromihe Rvytfzzk Rankweil Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
10.11.2015
Belgium Belgium
Not recruiting
10.11.2015
Czechia Czechia
Not recruiting
10.11.2015
Denmark Denmark
Not recruiting
10.11.2015
Estonia Estonia
Not recruiting
10.11.2015
France France
Not recruiting
10.11.2015
Germany Germany
Not recruiting
10.11.2015
Greece Greece
Not recruiting
10.11.2015
Hungary Hungary
Not recruiting
10.11.2015
Ireland Ireland
Not recruiting
10.11.2015
Italy Italy
Not recruiting
10.11.2015
Latvia Latvia
Not recruiting
10.11.2015
Poland Poland
Not recruiting
10.11.2015
Portugal Portugal
Not recruiting
10.11.2015
Slovenia Slovenia
Not recruiting
10.11.2015
Spain Spain
Not recruiting
10.11.2015
The Netherlands The Netherlands
Not recruiting
10.11.2015

Trial locations

Investigated Drugs:

Pembrolizumab is a medication used in this clinical trial. It is an anti-PD-1 monoclonal antibody, which means it helps the immune system recognize and attack cancer cells. In this study, pembrolizumab is given to patients with early-stage non-small cell lung cancer (NSCLC) after they have had surgery to remove the cancer and possibly completed standard chemotherapy. The goal is to see if pembrolizumab can help prevent the cancer from coming back.

Investigated Diseases:

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease is often diagnosed at an advanced stage, as early symptoms can be mild or mistaken for other conditions. As it progresses, NSCLC can spread to other parts of the body, including the lymph nodes, bones, brain, and liver. The progression and symptoms can vary depending on the stage and specific subtype of the cancer.

Trial ID:
2023-509137-39-00
Protocol code:
MK-3475-091
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil

    Recruiting

    3 1 1 1
    Investigated Drugs:
    Belgium Bulgaria Czechia France Germany Greece +5

  • Phase 2 Neoadjuvant Study of Amivantamab with Lazertinib in Resectable EGFR‑Mutated Non‑Small Cell Lung Cancer Patients

    Recruiting

    2 1 1
    Investigated Drugs:
    Spain