Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515764-31-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants.
The planned study duration per study participant is up to 64 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed | Experimental |
| |
| Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed | Experimental |
| |
| Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed | Experimental | Pumitamig dose 3 for Phase 3 |
|
| Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed | Active Comparator |
| |
| Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel | Experimental |
| |
| Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pumitamig | Drug | Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs | For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen. | From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit |
| Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) | For substudies A and B. | From the first dose of IMP to the 90-day Follow-Up Visit |
| Phase 2 - Objective response rate (ORR) | For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response. | Up to approximately 2 years |
| Phase 2 - Best percentage change from baseline in tumor size | For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1. | Up to approximately 2 years |
| Phase 3 - Progression free survival (PFS) assessed by blinded independent central review (BICR) | For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 3 - Overall survival (OS) | For substudies A and B. OS defined as the time from randomization to death from any cause | Up to approximately 5 years |
| Phase 2 - Duration of Response (DOR) | For substudies A and B. DOR defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
Participants with significant risk of hemorrhage (per investigator clinical judgment).
Have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BioNTech clinical trials patient information | Contact | +49 6131 9084 | 0 | patients@biontech.de |
| Name | Affiliation | Role |
|---|---|---|
| BioNTech Responsible Person | BioNTech SE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology | Recruiting | Birmingham | Alabama | 35223 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel | Experimental | Pumitamig dose 3 for Phase 3 |
|
| Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel | Active Comparator |
|
|
| Pembrolizumab | Drug | Intravenous infusion |
|
| Carboplatin | Drug | Intravenous infusion |
|
| Pemetrexed | Drug | Intravenous infusion |
|
| Paclitaxel | Drug | Intravenous infusion |
|
| Up to approximately 2 years |
| Phase 2 - Disease Control Rate (DCR) | For substudies A and B. DCR defined as the proportion of participants in whom a confirmed CR or confirmed PR or stable disease (per RECIST v1.1, stable disease assessed at least 6 weeks after randomization) is observed as best overall response. | Up to approximately 2 years |
| Phase 3 - PFS assessed by investigator | For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first. | Up to approximately 5 years |
| Phase 3 - ORR | For substudies A and B. ORR defined as the proportion of participants in whom a confirmed CR or confirmed PR (per RECIST v1.1) is observed as best overall response. | Up to approximately 2 years |
| Phase 3 - PFS rate as assessed by BICR | For substudies A and B. | At 6, 12, and 18 months |
| Phase 3 - PFS rate as assessed by investigator | For substudies A and B. | At 6, 12, and 18 months |
| Phase 3 - OS rate | For substudies A and B. | At 6, 12, 18, 24 months |
| Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-score 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30) | For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (i.e., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems). | Up to approximately 5 years |
| Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning | For substudies A and B. The EORTC QLQ-C30 is the most widely used cancer-specific, health related QoL instrument containing a total of 30 items and measures 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. All the scales and single-item measures range in score from 0 to 100 with a high scale score representing a higher response level (i.e., high score for functional scale is high/healthy level of functioning). | Up to approximately 5 years |
| Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29) | For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. | Up to approximately 5 years |
| Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 | For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. | Up to approximately 5 years |
| Phase 3 - Change from baseline in coughed up blood item of the EORTC QLQ-LC29 | For substudies A and B. The EORTC QLQ-LC29 is a disease-specific supplementary health-related quality-of-life (HRQoL) questionnaire module to be employed in conjunction with the QLQ-C30. It comprises 29 items and measures five multi-item scales (coughing, shortness of breath, side effects, tumor progression/existential issues, surgery-related symptoms) and five single items (coughing up blood, pain in chest, arm/shoulder and other parts of the body, and weight loss). All the scales and single-item measures range in score from 0 to 100 with a high score for the scales and single items representing a high level of symptomatology or problems. | Up to approximately 5 years |
| Phase 3 - Change from baseline in fatigue domain score scale of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | For substudies A and B. The NSCLC-SAQ is a 7-item patient-reported outcome measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms. | Up to approximately 5 years |
| Phase 3 - Change from baseline in pain domain score of the NSCLC-SAQ | For substudies A and B. The NSCLC-SAQ is a 7-item PRO measure for use in adults to assess symptoms of advanced non-small cell lung cancer. It contains five domains and accompanying items that were identified as symptoms of non small cell lung cancer: cough (1 item), pain (2), dyspnea (1), fatigue (2), and appetite (1). The (total) lowest score possible is 0, and the highest (total) score possible is 20. Higher scores indicate more severe symptoms. | Up to approximately 5 years |
| Phase 3 - Change from baseline in Functional Assessment of Cancer Therapy-General item 5 overall bother item (FACT-GP5). | For substudies A and B. The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies. The single-item GP5 ("I am bothered by side effects of treatment") is rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. | Up to approximately 5 years |
| Phase 3 - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship | For substudies A and B. AEs graded according to CTCAE v5.0. | From the first dose of IMP to the 90-day Follow-Up Visit |
| Phase 3 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) | For substudies A and B. | From the first dose of IMP to the 90-day Follow-Up Visit |
| Alaska Oncology and Hematology, LLC | Recruiting | Anchorage | Alaska | 99508 | United States |
| John Muir Clinical Research Center | Recruiting | Concord | California | 94520 | United States |
| University Of California - San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
| Clermont Oncology Center | Recruiting | Clermont | Florida | 34711 | United States |
| Mid Florida Cancer Centers | Recruiting | Orange City | Florida | 32763 | United States |
| Cleveland Clinic Florida - Martin North Hospital | Recruiting | Stuart | Florida | 34994 | United States |
| H. Lee Moffit Cancer center and research institute | Recruiting | Tampa | Florida | 33612 | United States |
| Cleveland Clinic Weston Hospital | Recruiting | Weston | Florida | 33331 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc. | Recruiting | Fort Wayne | Indiana | 46845 | United States |
| Physicians Clinic of Iowa | Recruiting | Cedar Rapids | Iowa | 52401-2112 | United States |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| Baptist Health Hardin | Recruiting | Elizabethtown | Kentucky | 42701 | United States |
| Frederick Health Hospital- James M Stockman Cancer Institute | Recruiting | Frederick | Maryland | 21704 | United States |
| Missouri Cancer Associates | Recruiting | Columbia | Missouri | 65201 | United States |
| SSM Health Cancer Care - St. Clare | Recruiting | Fenton | Missouri | 63026 | United States |
| Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) | Recruiting | Hastings | Nebraska | 68901-4470 | United States |
| Astera Cancer Care | Recruiting | East Brunswick | New Jersey | 08816 | United States |
| Summit Medical Group PA | Recruiting | Florham Park | New Jersey | 07932 | United States |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion | Recruiting | Paramus | New Jersey | 07652 | United States |
| Suny-Stony Brook University Cancer Center | Recruiting | Stony Brook | New York | 11794-9446 | United States |
| White Plains Hospital | Recruiting | White Plains | New York | 10601 | United States |
| Fletcher Hospital, Inc. dba AdventHealth Hendersonville | Recruiting | Hendersonville | North Carolina | 28792 | United States |
| Gabrail Cancer Center Research | Recruiting | Canton | Ohio | 44718 | United States |
| The Christ Hospital Cancer Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion | Recruiting | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195-0001 | United States |
| Dayton Physicians Network | Recruiting | Dayton | Ohio | 45415 | United States |
| Kettering Medical Center | Recruiting | Kettering | Ohio | 45429 | United States |
| Cleveland Clinic - Hillcrest Hospital | Recruiting | Mayfield Heights | Ohio | 44124 | United States |
| INTEGRIS Cancer Institute of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73109 | United States |
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Baptist Cancer Center | Recruiting | Memphis | Tennessee | 38120 | United States |
| Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| Millennium Research and Clinical Development, LLC | Active, not recruiting | Houston | Texas | 77090 | United States |
| Virginia Cancer Specialists - Arlington | Recruiting | Arlington | Virginia | 22201 | United States |
| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
| VCU Massey Cancer Center | Recruiting | Richmond | Virginia | 23298 | United States |
| Shenandoah Oncology | Recruiting | Winchester | Virginia | 22601 | United States |
| Cancer Research SA (CRSA) | Recruiting | Adelaide | 5000 | Australia |
| Royal Adelaide Hospital | Recruiting | Adelaide | 5000 | Australia |
| Flinders Medical Centre | Recruiting | Bedford Park | 5042 | Australia |
| Cairns Hospital | Recruiting | Cairns | 4870 | Australia |
| Dubbo Hospital | Recruiting | Dubbo | 2830 | Australia |
| Peninsula & South Eastern Haematology and Oncology Group | Recruiting | Frankston | 3199 | Australia |
| Icon Cancer Centre Kurralta Park | Recruiting | Kurralta Park | 5037 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | 3000 | Australia |
| Monash University - Monash Health -Monash Medical Centre | Recruiting | Melbourne | 3168 | Australia |
| Central West Cancer Care Centre | Recruiting | Orange | 2800 | Australia |
| Western Health Sunshine Hospital | Recruiting | St Albans | 3021 | Australia |
| ICON Cancer Care - Townsville | Recruiting | Townsville | 4812 | Australia |
| Cancer Care Wollongong Pty Limited | Recruiting | Wollongong | 2500 | Australia |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 3000 | Belgium |
| CHU HELORA, Hopital de Mons - Site Kennedy | Recruiting | Mons | 7000 | Belgium |
| VITAZ | Recruiting | Sint-Niklaas | 9100 | Belgium |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base de Sao Jose do Rio Preto | Recruiting | São José do Vale do Rio Preto | 15090-000 | Brazil |
| Complex Oncological Center Ruse Ltd | Recruiting | Rousse | 7000 | Bulgaria |
| Affiliated Hospital of Hebei University | Recruiting | Baoding | 071000 | China |
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | 100050 | China |
| Beijing Hospital | Recruiting | Beijing | 100730 | China |
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
| Jilin Cancer Hospital | Recruiting | Changchun | 130000 | China |
| Zhejiang Medical University, Zhejiang Cancer Hospital | Recruiting | Hangzhou | 310022 | China |
| Shandong University - Jinan Central Hospital | Recruiting | Jinan | 250013 | China |
| Yunnan Provincial Cancer Hospital | Recruiting | Kunming | 650118 | China |
| Jiangsu Peoples Hospital | Recruiting | Nanjing | 210029 | China |
| Shanghai Chest Hospital | Recruiting | Shanghai | 200030 | China |
| Cancer Hospital of Shantou University Medical College | Recruiting | Shantou | 515041 | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | 215006 | China |
| Chongqing University Three Gorges Hospital | Recruiting | Wanzhou | 404000 | China |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | 430071 | China |
| Northern Jiangsu Peoples Hospital (NJPH) | Recruiting | Yangzhou | 225001 | China |
| Taizhou Hospital of Zhejiang Province | Recruiting | Zhejiang | 317000 | China |
| Institut de Cancerologie de l'Ouest Paul Papin | Recruiting | Angers | 49055 | France |
| Centre Hospitalier Universitaire d'Angers (CHU Angers) | Recruiting | Angers | 49933 | France |
| Centre Hospitalier de la Cote Basque | Recruiting | Bayonne | 64109 | France |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre | Recruiting | Bordeaux | 33000 | France |
| Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Recruiting | Bordeaux | 33076 | France |
| Hospices Civils de Lyon - Hopital Louis Pradel | Recruiting | Bron | 69500 | France |
| CHU Caen Normandie | Recruiting | Caen | 14033 | France |
| Centre Francois Baclesse | Recruiting | Caen | 14076 | France |
| Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) | Recruiting | Créteil | 94010 | France |
| Centre Hospitalier Universitaire De Grenoble- Hopital Albert Michallon | Recruiting | La Tronche | 38700 | France |
| Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse | Recruiting | Lyon | 69004 | France |
| Institut Paoli-Calmettes | Recruiting | Marseille | 13009 | France |
| GHRMSA Hopital Emile Muller | Recruiting | Mulhouse | 68100 | France |
| Institut Curie - Centre de Recherche | Recruiting | Paris | 75005 | France |
| CIC Cochin Pasteur, Hopital Cochin | Recruiting | Paris | 75014 | France |
| Hopital Lyon Sud | Recruiting | Pierre-Bénite | 69310 | France |
| CHU de Rennes, Hopital de Pontchaillou | Recruiting | Rennes | 35033 | France |
| Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau | Recruiting | Saint-Herblain | 44805 | France |
| Centre Regional Lutte Contre Le Cancer Paul Strauss | Recruiting | Strasbourg | 67200 | France |
| Hopital Foch | Recruiting | Suresnes | 92151 | France |
| Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-Pre | Recruiting | Toulon | 83000 | France |
| Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP | Recruiting | Villejuif | 94805 | France |
| High Technology Hospital Medcenter LTD | Recruiting | Batumi | 6000 | Georgia |
| LLC Todua Clinic | Recruiting | Tbilisi | 0112 | Georgia |
| LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic | Recruiting | Tbilisi | 0144 | Georgia |
| New Hospitals | Recruiting | Tbilisi | 0162 | Georgia |
| Cancer Research Centre | Recruiting | Tbilisi | 0179 | Georgia |
| Uniklinik RWTH Aachen Medizinische Klinik IV | Recruiting | Aachen | 52074 | Germany |
| Evangelische Lungenklinik Berlin | Recruiting | Berlin | 13125 | Germany |
| Klinikum Chemnitz gGmbH | Recruiting | Chemnitz | 09116 | Germany |
| Universitätsklinikum Erlangen | Recruiting | Erlangen | 91054 | Germany |
| Klinikum Esslingen GmbH | Recruiting | Esslingen am Neckar | 73730 | Germany |
| Asklepios Fachkliniken Muenchen Gauting | Recruiting | Gauting | 82131 | Germany |
| SRH Wald-Kliniken Gera GmbH | Recruiting | Gera | 07548 | Germany |
| Thoraxklinik-Heidelberg Ggmbh | Recruiting | Heidelberg | 69126 | Germany |
| Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen | Recruiting | Immenhausen | 34376 | Germany |
| University Medical Center of Johannes Gutenberg-University Mainz | Recruiting | Mainz | 55131 | Germany |
| Staedtisches Klinikum Muenchen Bogenhausen | Recruiting | München | 81925 | Germany |
| MVZ for oncology and hematology Rhein-Kreis Neuss GmbH | Recruiting | Neuss | 41462 | Germany |
| Onkologische Tagesklinik Remscheid | Recruiting | Remscheid | 42853 | Germany |
| Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling | Recruiting | Wesseling | 50389 | Germany |
| Helios Klinikum Wuppertal-Universitaet Witten-Herdecke | Recruiting | Wuppertal | 42883 | Germany |
| Orszagos Onkologiai Intezet (National Institute of Oncology) | Recruiting | Budapest | 1122 | Hungary |
| Edelenyi Koch Robert Korhaz es Rendelointezet | Recruiting | Edelény | 3780 | Hungary |
| Azienda Ospedaliera San Giuseppe Moscati | Recruiting | Avellino | 83100 | Italy |
| Centro di Riferimento Oncologico | Recruiting | Aviano | 33081 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi | Recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliero - Universitaria di Ferrara | Recruiting | Cona | 44124 | Italy |
| Azienda Socio Sanitaria Territoriale di Cremona (ASST Cremona) | Recruiting | Cremona | 26100 | Italy |
| Ospedale San Luca | Recruiting | Lucca | 55100 | Italy |
| IRCCS Istituto Romagnolo per lo studio dei Tumori Dino Amadori (IRST) | Recruiting | Meldola | 47014 | Italy |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) | Recruiting | Milan | 20132 | Italy |
| UOC Oncoematologia AOU Luigi Vanvitelli | Recruiting | Naples | 80131 | Italy |
| Casa Di Cura Polispecialistica Dott Pederzoli | Recruiting | Peschiera del Garda | 37019 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | 00128 | Italy |
| Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) | Recruiting | Roma | 00144 | Italy |
| Fondazione Ospedale Isola Tiberina - Gemelli Isola | Recruiting | Rome | 00186 | Italy |
| Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte | Recruiting | Siena | 53100 | Italy |
| Ageo Central General Hospital | Recruiting | Ageo | 362-8588 | Japan |
| Hyogo Cancer Center | Recruiting | Akashi | 673-8558 | Japan |
| Tokyo Metropolitan Komagome Hospital | Recruiting | Bunkyō City | 113-8677 | Japan |
| National Hospital Organization Himeji Medical Center | Recruiting | Himeji | 670-8520 | Japan |
| National Hospital Organization Iwakuni Clinical Center | Recruiting | Iwakuni | 740-8510 | Japan |
| Shonan Kamakura General Hospital | Recruiting | Kanagawa | 247-8533 | Japan |
| Ishikawa Prefectural Central Hospital | Recruiting | Kanazawa | 920-8530 | Japan |
| Matsusaka Municipal Hospital | Recruiting | Matsusaka | 515-8544 | Japan |
| National Hospital Organization Shikoku Cancer Center | Recruiting | Matsuyama | 791-0280 | Japan |
| National Hospital Organization Tokyo Medical Center | Recruiting | Meguro City | 152-8902 | Japan |
| Iwate Medical University Hospital | Recruiting | Morioka | 028-3695 | Japan |
| Shizuoka Cancer Center | Recruiting | Nagaizumi-chō | 411-8777 | Japan |
| Japan Community Healthcare Organization Chukyo Hospital | Recruiting | Nagoya | 457-8510 | Japan |
| National Hospital Organization Nagoya Medical Center | Recruiting | Nagoya | 460-0001 | Japan |
| Nagoya University Hospital | Recruiting | Nagoya | 466-8560 | Japan |
| Niigata Cancer Center Hospital | Recruiting | Niigata | 951-8566 | Japan |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Recruiting | Osaka | 541-8567 | Japan |
| NHO Kinki Chuo Chest Medical Center | Recruiting | Sakai | 591-8555 | Japan |
| Sapporo Minamisanjo Hospital | Recruiting | Sapporo | 060-0063 | Japan |
| Sendai Kousei Hospital | Recruiting | Sendai | 981-0914 | Japan |
| Shibukawa Medical Center | Recruiting | Shibukawa | 377-0280 | Japan |
| Wakayama Medical University Hospital | Recruiting | Wakayama | 641-8510 | Japan |
| Yokohama Municipal Citizen's Hospital | Recruiting | Yokohama | 221-0855 | Japan |
| Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii | Recruiting | Gdansk | 80-211 | Poland |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie | Recruiting | Koszalin | 75-581 | Poland |
| FutureMeds Krakow | Recruiting | Krakow | 31-501 | Poland |
| Instytut MSF Sp. z o.o. | Recruiting | Lodz | 90-302 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie | Recruiting | Lublin | 20-954 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii | Recruiting | Poznan | 60-101 | Poland |
| NZOZ Medpolonia Sp. Z o.o. | Recruiting | Poznan | 60-693 | Poland |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu | Recruiting | Przemyśl | 37-700 | Poland |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Recruiting | Wroclaw | 53-413 | Poland |
| Coltea Clinical Hospital | Recruiting | Bucharest | 030171 | Romania |
| SC Gral Medical SRL | Recruiting | Bucharest | 031424 | Romania |
| Cardiomed | Recruiting | Cluj-Napoca | 400015 | Romania |
| S.C. Medisprof S.R.L, Oncologie medicala | Recruiting | Cluj-Napoca | 400641 | Romania |
| Radiotherapy Center Cluj | Recruiting | Cluj-Napoca | 407280 | Romania |
| Onco Clinic Consult SA | Recruiting | Craiova | 200094 | Romania |
| Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) | Recruiting | Craiova | 200542 | Romania |
| Centrul de Oncologie Euroclinic srl | Recruiting | Iași | 700106 | Romania |
| Ovidius Clinical Hospital | Recruiting | Ovidiu | 905900 | Romania |
| Municipal Hospital Ploiesti | Recruiting | Ploieşti | 100337 | Romania |
| Oncomed | Recruiting | Timișoara | 300239 | Romania |
| Chungbuk National University Hospital | Recruiting | Cheongju-si | 28644 | South Korea |
| Chungnam National University Hospital (CNUH) | Recruiting | Daejeon | 35015 | South Korea |
| National Cancer Center | Recruiting | Goyang-si | 10408 | South Korea |
| Gachon University Gil Medical Center | Recruiting | Incheon | 21565 | South Korea |
| Gyeongsang National University Hospital (GNUH) | Recruiting | Jinju | 52727 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center (AMC) | Recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| The Catholic University Of Korea, St. Vincent's Hospital | Recruiting | Suwon | 16247 | South Korea |
| Ajou University Hospital | Recruiting | Suwon | 16499 | South Korea |
| CHUAC Hospital Teresa Herrera | Recruiting | A Coruña | 15006 | Spain |
| Hospital Universitario de Badajoz | Recruiting | Badajoz | 6006 | Spain |
| Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals | Recruiting | Barcelona | 8908 | Spain |
| Consorcio Hospitalario Provincial de Castellón | Recruiting | Castellon | 12002 | Spain |
| Complejo Hospitalario Universitario Insular Materno Infantil | Recruiting | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario De Leon | Recruiting | León | 24080 | Spain |
| Hospital Universitari de Lleida Arnau de Villanova | Recruiting | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Maranon (HGUGM) | Recruiting | Madrid | 28007 | Spain |
| Clinica MD Anderson International | Recruiting | Madrid | 28033 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Recruiting | Majadahonda | 28222 | Spain |
| Hospital Universitario de Canarias | Recruiting | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital Universitario Virgen del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario Nuestra Senora De Valme | Recruiting | Seville | 41014 | Spain |
| Fundacion Instituto Valenciano de Oncologia | Recruiting | Valencia | 46009 | Spain |
| Hospital General Universitario De Valencia | Recruiting | Valencia | 46014 | Spain |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) | Recruiting | Valencia | 46026 | Spain |
| Hospital Alvaro Cunqueiro | Recruiting | Vigo | 36312 | Spain |
| Hospital Universitario Miguel Servet de Zaragoza | Recruiting | Zaragoza | 50009 | Spain |
| Kantonspital Baden | Recruiting | Baden | 5404 | Switzerland |
| Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO) | Recruiting | Lausanne | 1011 | Switzerland |
| Faculty of Medicine Vajira Hospital, Navamindradhiraj University | Recruiting | Bangkok | 10300 | Thailand |
| Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
| Chiangrai Prachanukroh Hospital | Recruiting | Chiang Rai | 57000 | Thailand |
| Lampang Cancer Hospital | Recruiting | Lampang | 52000 | Thailand |
| HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University | Recruiting | Nakhon Nayok | 26120 | Thailand |
| Rajavithi Hospital | Recruiting | Ratchathewi | 10400 | Thailand |
| Baskent Universitesi Tip Fakultesi Adana Hastanesi | Recruiting | Adana | 1120 | Turkey (Türkiye) |
| Adana City Training and Research Hospital | Recruiting | Adana | 1370 | Turkey (Türkiye) |
| Gulhane Training and Research Hospital | Recruiting | Ankara | 06010 | Turkey (Türkiye) |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital | Recruiting | Ankara | 06200 | Turkey (Türkiye) |
| Hacettepe University Medicine Faculty | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hospital | Recruiting | Ankara | 06520 | Turkey (Türkiye) |
| Liv Hospital Ankara | Recruiting | Ankara | 06680 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Akdeniz University Hospital | Recruiting | Antalya | 7985 | Turkey (Türkiye) |
| Dicle University Faculty of Medicine Hospital | Recruiting | Diyarbakır | 21280 | Turkey (Türkiye) |
| Gaziantep Sanko University Medical Faculty | Recruiting | Gaziantep | 36020 | Turkey (Türkiye) |
| Bezmialem Foundation University Medical Faculty | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Istinye University Bahcesehir Liv Hospital | Recruiting | Istanbul | 34517 | Turkey (Türkiye) |
| Yeditepe University Kosuyolu Hospital | Recruiting | Istanbul | 34718 | Turkey (Türkiye) |
| Medical Point Izmir Hospital | Recruiting | Izmir | 35325 | Turkey (Türkiye) |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Recruiting | Kadıköy | 34722 | Turkey (Türkiye) |
| Kocaeli Universitesi Tip Fakultesi | Recruiting | Kocaeli | 41380 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Medical Faculty | Recruiting | Konya | 42080 | Turkey (Türkiye) |
| Medical Park Florya Hospital | Recruiting | Küçükçekmece | 34295 | Turkey (Türkiye) |
| Medicalpark Ordu Hospital | Recruiting | Ordu | 34752 | Turkey (Türkiye) |
| Karadeniz Technical University Faculty of Medicine | Recruiting | Ortahisar | 61080 | Turkey (Türkiye) |
| Sakarya University - Faculty of Medicine | Recruiting | Sakarya | 54290 | Turkey (Türkiye) |
| Ondokuz Mayis University Health Practice and Research Hospital | Recruiting | Samsun | 55280 | Turkey (Türkiye) |
| Acibadem Adana Hospital | Recruiting | Seyhan | 01130 | Turkey (Türkiye) |
| Medical Park Seyhan Hospital | Recruiting | Seyhan | 01170 | Turkey (Türkiye) |
| Mersin City Training and Research Hospital | Recruiting | Toroslar | 33240 | Turkey (Türkiye) |
| Gazi University Faculty of Medicine | Recruiting | Yenimahalle | 06560 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi (Koc University Hospital) | Recruiting | Zeytinburnu | 34010 | Turkey (Türkiye) |
| Royal United Hospital, Bath - Royal United Hospitals Bath NHS Foundation Trust | Recruiting | Bath | BA1 3NG | United Kingdom |
| Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust | Recruiting | Brighton | BN2 5BE | United Kingdom |
| Velindre NHS Trust, Velindre Cancer Centre | Recruiting | Cardiff | CF14 2TL | United Kingdom |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust | Recruiting | Chelsea | SW3 6JJ | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Recruiting | Cottingham | HU16 5JQ | United Kingdom |
| Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board | Recruiting | Glasgow | G12 0YN | United Kingdom |
| Clatterbridge Cancer Centre | Recruiting | Liverpool | L7 8YA | United Kingdom |
| University College Hospital | Recruiting | London | NW2 1PG | United Kingdom |
| Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust | Recruiting | London | SM2 5PT | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| Norfolk and Norwich University Hospital - Norfolk and Norwich University Hospitals NHS Foundation Trust | Recruiting | Norwich | NR4 7UY | United Kingdom |
| Cancer And Haematology Centre-The Churchill Hospital-Oxford University Hospitals | Recruiting | Oxford | OX3 7LJ | United Kingdom |
| Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust | Recruiting | Preston | PR2 9HT | United Kingdom |
| Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | S10 2SJ | United Kingdom |
| Southampton General Hospital | Recruiting | Southampton | SO16 6YD | United Kingdom |
| Musgrove Park Hospital-Taunton & Somerset NHS Foundation Trust | Recruiting | Taunton | TA1 5DA | United Kingdom |
| New Cross Hospital | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided