Study of Pembrolizumab with Chemotherapy for Patients with Resectable Stage II, IIIA, and IIIB Non-Small Cell Lung Cancer

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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 stages II, IIIA, and certain cases of stage IIIB. The study is investigating the effects of a treatment called Pembrolizumab, also known by its code name MK-3475, which is used in combination with chemotherapy drugs. The chemotherapy drugs involved in this study include Cisplatin, Gemcitabine, and Pemetrexed. These treatments are given to patients who have a type of lung cancer that can be surgically removed.

The purpose of the study is to see how well these treatments work when given before and after surgery. Some participants will receive the combination of chemotherapy and Pembrolizumab, while others will receive chemotherapy with a placebo. The study will monitor participants over a period of time to assess their recovery and overall health outcomes.

Participants will receive the treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will track important outcomes such as how long participants live without the cancer returning and their overall survival. Additionally, the study will look at the response of the cancer to the treatment and any side effects experienced by the participants. The trial aims to provide valuable information on the effectiveness of adding Pembrolizumab to standard chemotherapy for treating this type of lung cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including having a resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC).

A performance status assessment is conducted to ensure the ability to participate in the trial.

2 initial treatment phase

The initial treatment involves receiving a combination of chemotherapy drugs and possibly pembrolizumab, depending on the group assignment.

Chemotherapy drugs include cisplatin, gemcitabine, and pemetrexed, administered through intravenous infusion.

Pembrolizumab, if administered, is given as a 25 mg/mL solution for infusion.

3 surgery

Following the initial treatment phase, surgery is performed to remove the tumor.

The timing of the surgery is determined based on the response to the initial treatment.

4 post-surgery treatment

After surgery, additional treatment may be administered, which could include further chemotherapy and pembrolizumab infusions.

The purpose of this phase is to eliminate any remaining cancer cells and reduce the risk of recurrence.

5 follow-up and monitoring

Regular follow-up visits are scheduled to monitor health status and assess the effectiveness of the treatment.

Imaging tests and other assessments are conducted to evaluate event-free survival and overall survival.

Who Can Join the Study?

  • Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC. This means the lung cancer is at a stage where it can be surgically removed and has not been treated before.
  • If male, must agree to use contraception or practice abstinence and refrain from donating sperm during the treatment period and for a certain time after the last dose of the study treatment.
  • If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply:
    • Not a woman of childbearing potential (WOCBP), meaning she cannot become pregnant.
    • A WOCBP who agrees to follow contraceptive guidance during the treatment period and for a certain time after the last dose of the study treatment. She also agrees not to donate eggs or freeze/store them for future use during this period.
  • Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing. This involves providing a sample of the tumor for testing.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization. This is a scale used to assess how well a patient can perform daily activities.
  • Have adequate organ function, meaning the organs are working well enough to participate in the study.

Who Cannot Join the Study?

  • Participants who have had any other type of cancer in the past, except for certain skin cancers that have been treated.
  • Participants who have serious heart problems, such as heart failure or a recent heart attack.
  • Participants who have uncontrolled high blood pressure.
  • Participants who have an active infection that requires treatment with antibiotics.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a known allergy to the study medication or its ingredients.
  • Participants who have a history of certain lung diseases, such as interstitial lung disease, which affects the tissue and space around the air sacs of the lungs.
  • Participants who have received another investigational drug within a certain period before the study.
  • Participants who have had major surgery within a certain period before the study.
  • Participants who have a history of drug or alcohol abuse that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Lungenfachklinik Immenhausen Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Katholisches Klinikum Koblenz Montabaur gGmbH Koblenz Germany
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH Hemer Germany
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
Polyclinique De Limoges Limoges France
Oncocenter Oncologie Clinica S.R.L. Timisoara Romania
Kaiserswerther Diakonie Duesseldorf Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Centre Hospitalier Universitaire Rouen Rouen France
Radiotherapy Center Cluj S.R.L. Bucharest Romania
Virgen del Rocío University Hospital Sevilla Spain
Les Hopitaux Universitaires De Strasbourg STRASBOURG, Alsace France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Zentralklinik Bad Berka GmbH Bad Berka Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Vitaz Sint-Niklaas Belgium
Medicover S.R.L. Bucharest Romania
Radiotherapy Center Cluj S.R.L. Floresti Romania
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Complejo Hospitalario Universitario Insular Materno Infantil Las Palmas De Gran Canaria Spain
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Pelican Impex S.R.L. Oradea Romania
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Vilnius University Hospital Vilnius Lithuania
North Estonia Medical Centre Foundation Tallin Estonia
Assistance Publique Hopitaux De Paris Creteil France
Direction Centrale Du Service De Sante Des Armees Toulon France
Ijlfqhxo Rrzjyacnu Pib Lg Srjmri Dvl Txqzgb Ddqg Aetrisg Ihar Slkhdx Meldola Italy
Rvjon Anktovcl kyikybvz uqvlwirqfeqzv sswsvnsa Sik Riga Latvia
Hsqblfrb Dg Lr Sgheu Cidw I Stnk Pdm Barcelona Spain
Cwwd Uvmakccfvs Hilezzni Cork Ireland
Ijmjaqjt Cibbte Dfgmsrchzpwywatag L'hospitalet De Llobregat Spain
Duhjmdtysuib Ceafszg Odsabxret Pxspnswyyozs I Hdiuhkjwvzt Wroclaw Poland
Efargow Mechelen Belgium
Hnortdih Usfwznxiinrfx Hazhhhbu Tgdbe y Pbmhmy Ibwqnsnu Cdfnzg dorfucpnizdepkeyp (rkra Badalona Spain
Hwysyljc Vfyh dunjnmjv Barcelona Spain
Ijfzpvtq Clluv Paris France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
09.05.2018
Estonia Estonia
Not recruiting
09.05.2018
France France
Not recruiting
09.05.2018
Germany Germany
Not recruiting
09.05.2018
Ireland Ireland
Not recruiting
09.05.2018
Italy Italy
Not recruiting
09.05.2018
Latvia Latvia
Not recruiting
09.05.2018
Lithuania Lithuania
Not recruiting
09.05.2018
Poland Poland
Not recruiting
09.05.2018
Romania Romania
Not recruiting
09.05.2018
Spain Spain
Not recruiting
09.05.2018

Trial locations

Pembrolizumab (MK-3475) is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in treating various types of cancer, including non-small cell lung cancer (NSCLC), by blocking a specific protein that prevents the immune system from effectively targeting cancer cells.

Platinum Doublet Chemotherapy is a combination of two chemotherapy drugs that contain platinum. This therapy is commonly used to treat non-small cell lung cancer (NSCLC). The platinum-based drugs work by damaging the DNA of cancer cells, which stops them from growing and dividing. This type of chemotherapy is often used to shrink tumors before surgery or to eliminate any remaining cancer cells after surgery.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is often diagnosed at an advanced stage, as early symptoms can be mild or mistaken for other conditions. The disease progresses as cancer cells grow and potentially spread to other parts of the body, including lymph nodes and distant organs. Treatment often involves a combination of surgery, chemotherapy, and radiation, depending on the stage and specific characteristics of the cancer.

Trial ID:
2023-504820-24-00
Protocol code:
MK-3475-671
NCT ID:
NCT03425643
Trial Phase:
Therapeutic confirmatory (Phase III)

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