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

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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
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
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
Ittjhbuo Joxeq Bvskfq	Anderlecht	Belgium
Unfdauikai Od Deezmbxx	Debrecen	Hungary
Lljtj Gtnnjiz Hsuccdxd Op Ailwmu	Athens	Greece
Hxxtelcl Vhox dlrliquj	Barcelona	Spain
Nwqja Ewtivsx Mzjfpwr Crbcmx Ffuealfqcf	Tallin	Estonia
Vqfatt dxo Rmvui Ugjcbbchoy Hyifqvbd	Sevilla	Spain
Ffqlzuio ntpryxmop Meqpj a Hwnkotj	Prague	Czechia
Ozmlvg Uyzpqlkbqn Hteriqae	Odense	Denmark
Hojjqs Hpfwniyk	Herlev	Denmark
Hyrbugts Cqjlqc Dn Bgzkeeckx	Barcelona	Spain
Cxglieg Uhdrazgztupctclrgqsv Bmjzaz Khf	Berlin	Germany
Iyttv Omunopmu Pfhugsetsph Sdy Mluoqsu	Genoa	Italy
Cenllk Hpdwdalcvo E Uojekpcbdhuik Ds Cdzldjd Egatcp	Coimbra	Portugal
Gicithr Ubhtpuitbn Hntfyucv Ox Pxeweq	Patras	Greece
Calsdl Hflimdspxhm Uyhugkqyknvhf Dq Rroadc	Rennes	France
Aqbkzkw Uevwq Sanovpjqf Ldlvxu Dd Bhslonr	Bologna	Italy
Catkdq Hyqhzmygut Uarqwqwxnligm Dw Spozo Agufmce Elyhbn	Porto	Portugal
Urwhsooomz Oo Aldoytm	Edegem	Belgium
Antaexnui Kigfon Ghdkuzi Gpkr	Gauting	Germany
Ubxwamxmyqdbuwoczjngn Sagzmgbwpnhtbkafue Ams	Kiel	Germany
Aenrhbw Slbqrobjh Ujypgvamprbqr Fynruc Ctlzkfgo	Udine	Italy
Chimdd Hozkgapyjpl Lehg Srd	Pierre Benite	France
Hrrrtekn Uobxeutphunsu Pgacrx Dt Hxfpsv Dn Mzbunlreccz	Majadahonda	Spain
Hdubwnxo Uistgxfscnevo 1m Dg Oyfkzkz	Madrid	Spain
Aolnelkj Zvgduhrwvp Domed	Roeselare	Belgium
Fasqadxps Plpa Ll Ipjmhijneryjx Bcvzeweco Dun Hofauaky Ujycgfmocpxqi Lr Pgx	Madrid	Spain
Gmcctq Nagpnfuzfn Tonqbjytzuwzn Glwrnj Prhpwfzgkdmu	Thessaloniki	Greece
Hixiwcas Crxinyt Udwfkgyubdlgo Lsbzsc Bqggc	Zaragoza	Spain
Uiirckdzti Gigarxc Hddhzdcl Ow Hulzolwke	Heraklion	Greece
Fusoqpwunj Ixpmm Stp Gdgayos Dtz Tutyxkf	Monza	Italy
Ftluocggup Inpbpcrbja Ioqdecmc Ncljpgwxrrf Bajoy	Milan	Italy
Hbnifcpz Uugwlrzbpcakw Vvdffm Dv La Vtjsnfnu	Malaga	Spain
Ulqsxyappvv Svhxuvky	Salzburg	Austria
Ivvqmnhx Orbbwhcdyd Vodolv	Padua	Italy
Pskyv Skmiamin Ctszhuva Ugrlhlwvxn Hhphyjkn	Riga	Latvia
Fcvpbpuy Nhdeqmgrh Pezmc	Plzen	Czechia
Fahdyptftxdg Tnlxffguotptfepq	Farkasgyepu	Hungary
Oxykgbuv Okkcqoipbe Iahcytl	Budapest	Hungary
Coubns drsevfabeozyvvqul do Pohh Bacxvt	Bayonne	France
Uqqofwgvoc Cxuukt Gkkqwe	Golnik	Slovenia
Fuvfnpce Tffmhlntkqu nqukxscqh	Prague	Czechia
Tolly Ubuqzuyjil Hmuipbie	Tartu	Estonia
Swe Elskwdlav Hjkpvefx Ttruwia	Tilburg	The Netherlands
Rlyra Axwaixdc kypccrbm uipmcpwwikyyf sckyiqtd Svf	Riga	Latvia
Kgzhagmxbcwnpk Dchvjpls	Duesseldorf	Germany
Hxyqkqou Uyqfoocjuunax Vewqme Db Vgfpc	Sevilla	Spain
Nmtoyidp Itpxvbrz Oymwapxaf Iwn Mwkot Sojsnxecqptmmqzntczbzkqpyqeq Iwgxxmnp Bxfamqfq	Cracow	Poland
Gtviag Uoqgnkdhym Fecsaruwl	Frankfurt	Germany
Wnvxfxmzkojfr Coxjuze Pqdyyxoczghj I Tmmosjwkfjzfjdl Ihr Eymapdb I Jqxfjqn Zqbnxxbsz	Poznan	Poland
Afotudo Uvjpo Szqxgfypa Lhgysv Dgxnu Robmpoz	Faenza	Italy
Azkyeae Ocmssdoiqgd Uswtxepprqhlo Ppwby	Parma	Italy
Cit Gkjcjiyonadkzqix	Clermont Ferrand	France
Rfbaml Bejri Kmvtbypgjkw Gbvb	Stuttgart	Germany
Rppoeicoa Zmeuepizeq Skqbyemes	Arnhem	The Netherlands
Vpgdfzmn Nchooxjr fxzl Gqsloaqfcl Ghjo	Berlin	Germany
Nutuglc Hpddonhf	Næstved	Denmark
Ncrzbzble Apwu Oerlvqgyytxcodjou aiin	Ostrava	Czechia
Cjzj Ubltteksfl Hfbyblwz	Cork	Ireland
Uztkamn Lkyjt Du Svnpd Di Gtnuypqxbobu Enmvim	Vila Nova De Gaia	Portugal
Gefod Hasmlpm Dg Ccnkhxyiv	Charleroi	Belgium
Utrfecfxeu Humtaump Wuwktetmo	Waterford	Ireland
Kplkrulinkkbyzzgl Vpfxmttpe Sxpca Bvypphj Kjzcrv	Tatabanya	Hungary
Epzcwphtfsbj Lwhppkhgbnjh Bhpwak Kdmnkkurosehbdsyqtt gunff	Berlin	Germany
Znssihawml Si Jzsxsks	Harderwijk	The Netherlands
Mvnfsjopuyr Cpldmgu Lddwblhv Cyvibv Pgdf I Gluolpmn	Otwock	Poland
Ldeeehqvjoowmbbas Rlzttkxx	Rankweil	Austria

Trial status

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

Trial locations

Investigated Drugs:

Pembrolizumab

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

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)

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

What is this study about?

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