A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Phase 3

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Biological: Intismeran autogene; Biological: Pembrolizumab; Other: Placebo

• Registration Number: NCT06077760
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Study Start: 2023-12-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2030-06-25
• Study Completion: 2035-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 868

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

• Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
• Has no evidence of disease before randomization.
• Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
• No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

• Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Received prior neoadjuvant therapy for their current NSCLC diagnosis.
• Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
• Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
• Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
• Known additional malignancy that is progressing or has required active treatment within the past 5 years.
• Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Active infection requiring systemic therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intismeran autogene + Pembrolizumab	Intismeran autogene	Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Placebo + Pembrolizumab	Pembrolizumab	Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Placebo + Pembrolizumab	Placebo	Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.
Intismeran autogene + Pembrolizumab	Pembrolizumab	Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Primary Outcome Measures

Name	Time	Method
Disease- Free Survival (DFS)	Up to ~78 months	DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Lung Cancer Specific Survival (LCSS)	Up to ~12 years	LCSS is defined as the time from randomization to death due to lung cancer.
Distant Metastasis-Free Survival (DMFS)	Up to ~12 years	DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first.
Overall Survival (OS)	Up to ~12 years	OS is defined as the time from randomization to death due to any cause.
Number of Participants Who Experience an Adverse Event (AE)	Up to ~15 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score	Baseline and up to ~12 years	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30	Baseline and up to ~12 years	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30	Baseline and up to ~12 years	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30	Baseline and up to ~12 years	The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.
Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24	Baseline and up to ~12 years	The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to the question "Have you had pain in your chest?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. The change from baseline in chest pain (EORTC QLQ-LC24 Item 40) score will be presented.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to ~12 months	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24	Baseline and up to ~12 years	The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to questions about coughing will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more coughing. The change from baseline in coughing (EORTC QLQ-LC24 Items 31 and 52) combined score will be presented.

Trial Locations

Locations (187)

Alaska Oncology and Hematology ( Site 0039); 🇺🇸 Anchorage, Alaska, United States

YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020); 🇺🇸 Yuma, Arizona, United States

UCLA Clinical & Translational Research Center (CTRC) ( Site 0059); 🇺🇸 Los Angeles, California, United States

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074); 🇺🇸 Orange, California, United States

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030); 🇺🇸 Orange, California, United States

UCHealth Memorial Hospital-Heme Onc ( Site 0052); 🇺🇸 Colorado Springs, Colorado, United States

Mid Florida Hematology and Oncology Center ( Site 0014); 🇺🇸 Orange City, Florida, United States

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013); 🇺🇸 Orlando, Florida, United States

Moffitt Cancer Center ( Site 0078); 🇺🇸 Tampa, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012); 🇺🇸 Marietta, Georgia, United States

Beacon Cancer Care ( Site 0044); 🇺🇸 Post Falls, Idaho, United States

University of Iowa-Holden Comprehensive Cancer Center ( Site 0062); 🇺🇸 Iowa City, Iowa, United States

Saint Elizabeth Healthcare ( Site 0092); 🇺🇸 Edgewood, Kentucky, United States

The University of Louisville, James Graham Brown Cancer Center ( Site 0037); 🇺🇸 Louisville, Kentucky, United States

University of Michigan Clinical Trials Office ( Site 0058); 🇺🇸 Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan ( Site 4003); 🇺🇸 Grand Rapids, Michigan, United States

St. Vincent Frontier Cancer Center ( Site 0043); 🇺🇸 Billings, Montana, United States

NHO Revive Research Institute, LLC ( Site 4009); 🇺🇸 Lincoln, Nebraska, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036); 🇺🇸 Hackensack, New Jersey, United States

New York Oncology Hematology, P.C. ( Site 4012); 🇺🇸 Albany, New York, United States

Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080); 🇺🇸 Bronx, New York, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0; 🇺🇸 Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center ( Site 0010); 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 0034); 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0029); 🇺🇸 New York, New York, United States

Stony Brook University-Cancer Center ( Site 0072); 🇺🇸 Stony Brook, New York, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0063); 🇺🇸 Fargo, North Dakota, United States

Altru Health System ( Site 0040); 🇺🇸 Grand Forks, North Dakota, United States

Summa Health ( Site 4011); 🇺🇸 Akron, Ohio, United States

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0028); 🇺🇸 Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center ( Site 0023); 🇺🇸 Cleveland, Ohio, United States

OSU Brain and Spine Hospital ( Site 0016); 🇺🇸 Columbus, Ohio, United States

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082); 🇺🇸 Corvallis, Oregon, United States

Thomas Jefferson University - Clinical Research Institute ( Site 0006); 🇺🇸 Philadelphia, Pennsylvania, United States

Medical University of South Carolina-Hollings Cancer Center ( Site 0050); 🇺🇸 Charleston, South Carolina, United States

Sanford Cancer Center ( Site 0075); 🇺🇸 Sioux Falls, South Dakota, United States

Thompson Cancer Survival Center ( Site 0097); 🇺🇸 Knoxville, Tennessee, United States

SCRI Oncology Partners ( Site 7001); 🇺🇸 Nashville, Tennessee, United States

UT Southwestern Medical Center ( Site 0061); 🇺🇸 Dallas, Texas, United States

Inova Schar Cancer Institute ( Site 0003); 🇺🇸 Fairfax, Virginia, United States

Swedish Medical Center-Swedish Cancer Institute ( Site 0088); 🇺🇸 Seattle, Washington, United States

Clinica Adventista Belgrano-Oncology ( Site 2901); 🇦🇷 Caba., Buenos Aires, Argentina

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2912); 🇦🇷 Caba, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 2911); 🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908); 🇦🇷 Mar del Plata, Buenos Aires, Argentina

Fundacion Estudios Clinicos-Oncology ( Site 2907); 🇦🇷 Rosario, Santa Fe, Argentina

Sanatorio Parque ( Site 2904); 🇦🇷 Rosario, Santa Fe, Argentina

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203); 🇦🇺 Melbourne, Victoria, Australia

St Vincent's Hospital-Oncology Clinical Trials ( Site 0202); 🇦🇺 Melbourne, Victoria, Australia

One Clinical Research ( Site 0200); 🇦🇺 Nedlands, Western Australia, Australia

Antwerp University Hospital-Thoracic Oncology ( Site 0603); 🇧🇪 Edegem, Antwerpen, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi; 🇧🇪 Yvoir, Namur, Belgium

AZORG Campus Aalst-Moorselbaan ( Site 0604); 🇧🇪 Aalst, Oost-Vlaanderen, Belgium

VITAZ ( Site 0600); 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 3007); 🇧🇷 Fortaleza, Ceara, Brazil

Liga Norte Riograndense Contra o Câncer ( Site 3001); 🇧🇷 Natal., Rio Grande Do Norte, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 3003); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 3002); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 3004); 🇧🇷 Barretos, Sao Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 3013); 🇧🇷 São José do Rio Preto, Sao Paulo, Brazil

Instituto Nacional de Câncer - INCA ( Site 3000); 🇧🇷 Rio de Janeiro, Brazil

Hospital Samaritano De Sao Paulo ( Site 3006); 🇧🇷 Sao Paulo, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3005); 🇧🇷 Sao Paulo, Brazil

Cross Cancer Institute ( Site 0105); 🇨🇦 Edmonton, Alberta, Canada

William Osler Health System ( Site 0101); 🇨🇦 Brampton, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0102); 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0104); 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre ( Site 0100); 🇨🇦 Montréal, Quebec, Canada

Orlandi Oncologia-Oncology ( Site 3102); 🇨🇱 Santiago, Region M. De Santiago, Chile

FALP-UIDO ( Site 3100); 🇨🇱 Santiago, Region M. De Santiago, Chile

Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 3104); 🇨🇱 Santiago, Region M. De Santiago, Chile

Bradfordhill-Clinical Area ( Site 3103); 🇨🇱 Santiago, Region M. De Santiago, Chile

ONCOCENTRO APYS ( Site 3105); 🇨🇱 Viña del Mar, Valparaiso, Chile

CIMCA ( Site 3300); 🇨🇷 San José, San Jose, Costa Rica

ICIMED ( Site 3301); 🇨🇷 San Jose, Costa Rica

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0700); 🇨🇿 Brno, Brno-mesto, Czechia

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 0702); 🇨🇿 Ostrava, Ostrava Mesto, Czechia

Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0701); 🇨🇿 Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze ( Site 0703); 🇨🇿 Praha 2, Czechia

Rigshospitalet ( Site 0801); 🇩🇰 Copenhagen, Hovedstaden, Denmark

Odense Universitetshospital ( Site 0800); 🇩🇰 Odense C, Syddanmark, Denmark

North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901); 🇪🇪 Tallinn, Harjumaa, Estonia

Tartu University Hospital-Radiotherapy and oncology ( Site 0900); 🇪🇪 Tartu, Tartumaa, Estonia

Tampereen yliopistollinen sairaala-Oncology ( Site 1001); 🇫🇮 Tampere, Pirkanmaa, Finland

Vaasan Keskussairaala-Department of Clinical Oncology ( Site 1004); 🇫🇮 Vaasa, Pohjanmaa, Finland

Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 1003); 🇫🇮 Oulu, Pohjois-Pohjanmaa, Finland

Turku University Hospital-The Department of Pulmonary Medicine ( Site 1000); 🇫🇮 Turku, Varsinais-Suomi, Finland

Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100); 🇫🇷 Strasbourg, Alsace, France

CHU Bordeaux Haut-Leveque ( Site 1106); 🇫🇷 Pessac, Aquitaine, France

Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 1108); 🇫🇷 Marseille, Bouches-du-Rhone, France

Seoul National University Hospital ( Site 0400); 🇰🇷 Seoul, Korea, Republic of

Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre ( Site 1107); 🇫🇷 Caen, Calvados, France

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102); 🇫🇷 Montpellier, Herault, France

Institut de Cancérologie de l'Ouest ( Site 1101); 🇫🇷 ANGERS cedex 02, Maine-et-Loire, France

Taipei Medical University Hospital ( Site 0502); 🇨🇳 Taipei, Taiwan

CHU GABRIEL MONTPIED ( Site 1105); 🇫🇷 Clermont-Ferrand, Puy-de-Dome, France

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1104); 🇫🇷 Paris, France

Klinikum Esslingen-Klinik für Kardiologie und Pneumologie ( Site 1201); 🇩🇪 Esslingen, Baden-Wurttemberg, Germany

Asklepios Klinik Gauting GmbH-Oncology ( Site 1209); 🇩🇪 Gauting, Bayern, Germany

Klinikverbund Allgäu gGmbH ( Site 1205); 🇩🇪 Kempten, Bayern, Germany

Universitaetsklinikum Regensburg ( Site 1204); 🇩🇪 Regensburg, Bayern, Germany

Augusta-Kranken-Anstalt ( Site 1213); 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1202); 🇩🇪 Münster, Nordrhein-Westfalen, Germany

Brüderkrankenhaus St. Josef Paderborn-Klinik für Hämatologie und Onkologie ( Site 1214); 🇩🇪 Paderborn, Nordrhein-Westfalen, Germany

SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 1200); 🇩🇪 Gera, Thuringen, Germany

Helios Klinikum Emil von Behring Berlin-Zehlendorf-Lungenklinik Heckeshorn ( Site 1208); 🇩🇪 Berlin, Germany

Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 1301); 🇬🇷 Athens, Attiki, Greece

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol; 🇬🇷 Athens, Attiki, Greece

European Interbalkan Medical Center-Oncology Department ( Site 1302); 🇬🇷 Thessaloniki, Greece

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401); 🇭🇺 Kecskemét, Bacs-Kiskun, Hungary

Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402); 🇭🇺 Pecs, Baranya, Hungary

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz - Pulmonologia Osztaly ( Site 1404); 🇭🇺 Gyor, Gyor-Moson-Sopron, Hungary

Reformatus Pulmonologiai Centrum ( Site 1405); 🇭🇺 Törökbálint, Pest, Hungary

Somogy Varmegyei Kaposi Mor Oktato Korhaz -Onkologiai Kozpont ( Site 1407); 🇭🇺 Kaposvár, Somogy, Hungary

Tallaght University Hospital ( Site 3903); 🇮🇪 Dublin, Ireland

CRO-IRCCS-Clinical Oncology ( Site 1510); 🇮🇹 Aviano, Friuli-Venezia Giulia, Italy

P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1506); 🇮🇹 Udine, Friuli-Venezia Giulia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1504); 🇮🇹 Milan, Lombardia, Italy

ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 1511); 🇮🇹 Milan, Milano, Italy

A.O.R.N. Ospedale dei Colli - Monaldi V.-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1508); 🇮🇹 Naples, Napoli, Italy

Instituto Tumori Giovanni Paolo II-SSD Oncologia Medica per la Patologia Toracica ( Site 1507); 🇮🇹 Bari, Puglia, Italy

POLICLINICO "G. RODOLICO"-UOC Oncologia Medica ( Site 1503); 🇮🇹 Catania, Sicilia, Italy

AO Santa Maria della Misericordia-Oncology Department ( Site 1501); 🇮🇹 Perugia, Umbria, Italy

Azienda Ospedaliera Santa Croce e Carle ( Site 1500); 🇮🇹 Cuneo, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502); 🇮🇹 Novara, Italy

St. Marianna University Hospital ( Site 3802); 🇯🇵 Kawasaki, Kanagawa, Japan

Kanagawa Cancer Center ( Site 3801); 🇯🇵 Yokohama, Kanagawa, Japan

Kindai University Hospital ( Site 3803); 🇯🇵 Osakasayama, Osaka, Japan

Hiroshima University Hospital ( Site 3804); 🇯🇵 Hiroshima, Japan

Chungbuk National University Hospital-Internal medicine ( Site 0402); 🇰🇷 Cheongju-si, Chungbuk, Korea, Republic of

National Cancer Center-Lung Cancer Center ( Site 0403); 🇰🇷 Goyang-si, Kyonggi-do, Korea, Republic of

Seoul National University Bundang Hospital-Medical Oncology ( Site 0404); 🇰🇷 Seongnam, Kyonggi-do, Korea, Republic of

The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 0406); 🇰🇷 Suwon-si, Kyonggi-do, Korea, Republic of

Keimyung University Dongsan Hospital CRC room 1 ( Site 0407); 🇰🇷 Daegu, Taegu-Kwangyokshi, Korea, Republic of

Asan Medical Center-Department of Oncology ( Site 0405); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center ( Site 0401); 🇰🇷 Seoul, Korea, Republic of

RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia ( Site 1600); 🇱🇻 Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701); 🇱🇹 Kaunas, Kauno Apskritis, Lithuania

National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1700); 🇱🇹 Vilnius, Vilniaus Miestas, Lithuania

University Malaya Medical Centre ( Site 3502); 🇲🇾 Lembah Pantai, Kuala Lumpur, Malaysia

National Cancer Institute-Radiotherapy and Oncology ( Site 3506); 🇲🇾 Putrajaya, Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan ( Site 3504); 🇲🇾 Kuantan, Pahang, Malaysia

Hospital Pulau Pinang ( Site 3505); 🇲🇾 George Town, Pulau Pinang, Malaysia

Sarawak General Hospital ( Site 3500); 🇲🇾 Kuching, Sarawak, Malaysia

CIO - Centro de Inmuno-Oncología de Occidente ( Site 3403); 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 3408); 🇲🇽 Monterrey, Nuevo Leon, Mexico

Mediadvance Clinical ( Site 3404); 🇲🇽 Chihuahua, Mexico

New Zealand Clinical Research (Christchurch) ( Site 0300); 🇳🇿 Christchurch, Canterbury, New Zealand

Harbour Cancer & Wellness ( Site 0301); 🇳🇿 Auckland, New Zealand

Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900); 🇳🇴 Lørenskog, Akershus, Norway

Drammen Sykehus, Vestre Viken HF ( Site 1903); 🇳🇴 Drammen, Buskerud, Norway

Stavanger Universitetssykehus ( Site 1901); 🇳🇴 Stavanger, Rogaland, Norway

Metro Davao Medical and Research Center ( Site 3602); 🇵🇭 Davao City, Davao Del Sur, Philippines

ST. LUKE'S MEDICAL CENTER ( Site 3606); 🇵🇭 Quezon City, National Capital Region, Philippines

CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 3601); 🇵🇭 San Juan City, Metro Manila, National Capital Region, Philippines

Taichung Veterans General Hospital-Chest ( Site 0503); 🇨🇳 Taichung, Taiwan

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II-Oddział Kliniczny Chirurgii Klatki Piersiowej i; 🇵🇱 Krakow, Malopolskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier; 🇵🇱 Warszawa, Mazowieckie, Poland

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001); 🇵🇱 Przemysl, Podkarpackie, Poland

Bialostockie Centrum Onkologii ( Site 2005); 🇵🇱 Bialystok, Podlaskie, Poland

Uniwersyteckie Centrum Kliniczne ( Site 2013); 🇵🇱 Gdansk, Pomorskie, Poland

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii; 🇵🇱 Olsztyn, Warminsko-mazurskie, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz; 🇵🇱 Poznan, Wielkopolskie, Poland

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 2703); 🇵🇹 Lisbon, Lisboa, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 2702); 🇵🇹 Porto, Portugal

Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica ( Site 2202); 🇸🇰 Banska Bystrica, Banskobystricky Kraj, Slovakia

Univerzitná nemocnica Bratislava - Nemocnica Ružinov ( Site 2201); 🇸🇰 Bratislava, Bratislavsky Kraj, Slovakia

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401); 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403); 🇪🇸 Majadahonda, Madrid, Comunidad De, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402); 🇪🇸 Pozuelo de Alarcon, Madrid, Spain

Hospital Quirón Málaga ( Site 2405); 🇪🇸 Málaga, Malaga, Spain

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400); 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404); 🇪🇸 Sevilla, Spain

Changhua Christian Hospital ( Site 0504); 🇨🇳 Changhua County, Changhua, Taiwan

National Taiwan University Cancer Center (NTUCC) ( Site 0500); 🇨🇳 Taipei City, Taipei, Taiwan

National Taiwan University Hospital - Hsinchu branch ( Site 0501); 🇨🇳 Hsinchu, Taiwan

National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505); 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital-Oncology ( Site 0506); 🇨🇳 Taipei, Taiwan

Medipol Mega Universite Hastanesi-oncology ( Site 2105); 🇹🇷 Stanbul, Istanbul, Turkey

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2107); 🇹🇷 Bornova, Izmir, Turkey

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2100); 🇹🇷 Ankara, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 2103); 🇹🇷 Ankara, Turkey

Liv Hospital Ankara-Oncology ( Site 2104); 🇹🇷 Ankara, Turkey

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2101); 🇹🇷 Ankara, Turkey

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2102); 🇹🇷 Istanbul, Turkey