Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03425643
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 797
- Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
- If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention.
- If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction 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.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
- Have adequate organ function.
- Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
- Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/sold organ transplant.
- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
- Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of Hepatitis B or Hepatitis C.
- Has a known history of active tuberculosis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
- Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
- Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
- Has received prior radiotherapy within 2 weeks of start of trial treatment.
- Has received a live vaccine within 30 days prior to the first dose of trial drug.
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
- Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NAC + Neoadjuvant/Adjuvant Pembrolizumab Pembrolizumab Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Placebo Cisplatin Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Placebo Placebo Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Pembrolizumab Cisplatin Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Pembrolizumab Gemcitabine Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Pembrolizumab Pemetrexed Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab \[200 mg, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Placebo Gemcitabine Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\]. NAC + Neoadjuvant/Adjuvant Placebo Pemetrexed Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\] in combination with platinum doublet NAC, consisting of cisplatin \[75 mg/m\^2, IV; given on cycle day 1\] and either Gemcitabine \[1000 mg/m\^2, IV; given on cycle days 1 and 8\] or Pemetrexed \[500 mg/m\^2, IV; given on cycle day 1\]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo \[normal saline, IV; given on cycle day 1\].
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS) Up to approximately 5 years EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).
Overall Survival (OS) Up to approximately 5 years OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).
- Secondary Outcome Measures
Name Time Method Major Pathological Response (mPR) Rate Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.
Pathological Complete Response (pCR) Rate Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20) pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. The pCR rates as assessed by blinded independent pathologist are presented.
Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11 Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30) Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.
Number of Participants Who Experience an Adverse Event (AE) Up to approximately 71 weeks Number of Participants Who Experience Perioperative Complications Up to approximately 51 weeks following surgery Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be assessed.
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) Up to approximately 57 weeks
Trial Locations
- Locations (227)
UPMC Hillman Cancer Centers ( Site 0041)
🇺🇸Pittsburgh, Pennsylvania, United States
PPG-Oncology ( Site 0043)
🇺🇸Fort Wayne, Indiana, United States
Ingalls Memorial Hospital ( Site 0044)
🇺🇸Harvey, Illinois, United States
Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)
🇺🇸Commack, New York, United States
Pacific Cancer Care ( Site 0035)
🇺🇸Monterey, California, United States
Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)
🇺🇸Harrison, New York, United States
Stanford University, Stanford Cancer Center ( Site 0046)
🇺🇸Stanford, California, United States
Mayo Clinic Jacksonville ( Site 0022)
🇺🇸Jacksonville, Florida, United States
Northwest Oncology and Hematology ( Site 0001)
🇺🇸Elk Grove Village, Illinois, United States
Providence Saint Joseph Medical Center ( Site 0061)
🇺🇸Burbank, California, United States
John Wayne Cancer Institute ( Site 0049)
🇺🇸Santa Monica, California, United States
LKI Lungenfachklinik Immenhausen ( Site 0268)
🇩🇪Immenhausen, Hessen, Germany
Hospital de Caridade de Ijui ( Site 0153)
🇧🇷Ijui, Rio Grande Do Sul, Brazil
Memorial Sloan Kettering Cancer Center ( Site 0060)
🇺🇸New York, New York, United States
Centro Regional Integrado de Oncologia ( Site 0160)
🇧🇷Fortaleza, Ceara, Brazil
St. Vincent Healthcare Frontier Cancer Center ( Site 0005)
🇺🇸Billings, Montana, United States
AZ Nikolaas ( Site 0225)
🇧🇪Sint-Niklaas, Oost-Vlaanderen, Belgium
Orange Health Services ( Site 0624)
🇦🇺Orange, New South Wales, Australia
St. Peter's Hospital Cancer Care Center ( Site 0039)
🇺🇸Albany, New York, United States
Instituto do Cancer do Ceara ( Site 0152)
🇧🇷Fortaleza, Ceara, Brazil
Stony Brook University Medical Center - Cancer Center ( Site 0019)
🇺🇸Stony Brook, New York, United States
Hospital Universitario Austral ( Site 0127)
🇦🇷Pilar, Buenos Aires, Argentina
Sanatorio Britanico ( Site 0125)
🇦🇷Rosario, Santa Fe, Argentina
Florence Nightingale Krankenhaus ( Site 0874)
🇩🇪Duesseldorf, Nordrhein-Westfalen, Germany
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)
🇧🇷Rio de Janeiro, Brazil
Clinique Francois Chenieux ( Site 0246)
🇫🇷Limoges, Haute-Vienne, France
Institut Curie ( Site 0250)
🇫🇷Paris, France
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)
🇦🇷Berazategui, Buenos Aires, Argentina
Fundacion Favaloro ( Site 0128)
🇦🇷Ciudad de Buenos Aires, Caba, Argentina
Hospital Privado Universitario de Córdoba ( Site 0139)
🇦🇷Cordoba, Argentina
UZ Gent ( Site 0224)
🇧🇪Gent, Oost-Vlaanderen, Belgium
St James Hospital ( Site 0451)
🇮🇪Dublin, Ireland
Universitaetsklinikum Leipzig AOeR ( Site 0277)
🇩🇪Leipzig, Sachsen, Germany
National Cancer Center Hospital East ( Site 0761)
🇯🇵Kashiwa, Chiba, Japan
IRCCS Ospedale San Raffaele di Milano ( Site 0303)
🇮🇹Milano, Italy
Westmead Hospital ( Site 0621)
🇦🇺Westmead, New South Wales, Australia
Asklepios Klinikum Hamburg ( Site 0271)
🇩🇪Hamburg, Germany
Beijing Cancer Hospital ( Site 0810)
🇨🇳Beijing, Beijing, China
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)
🇨🇦Montreal, Quebec, Canada
CHU de Toulouse - Hopital Larrey ( Site 0258)
🇫🇷Toulouse, Haute-Garonne, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)
🇫🇷Pierre-Benite, Rhone-Alpes, France
Hospital Paulistano - Amil Clinical Research ( Site 0822)
🇧🇷Sao Paulo, Brazil
Hospital Alemao Oswaldo Cruz ( Site 0158)
🇧🇷Sao Paulo, Brazil
HELIOS Klinikum Emil von Behring ( Site 0280)
🇩🇪Berlin, Germany
Lungenklinik Hemer ( Site 0269)
🇩🇪Hemer, Nordrhein-Westfalen, Germany
SRH Waldklinikum Gera GmbH ( Site 0272)
🇩🇪Gera, Thuringen, Germany
Universitaetsklinikum Carl Gustav Carus ( Site 0273)
🇩🇪Dresden, Sachsen, Germany
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)
🇨🇦Montreal, Quebec, Canada
Mathias Spital Rheine ( Site 0261)
🇩🇪Rheine, Nordrhein-Westfalen, Germany
Mid Western Cancer Centre ( Site 0450)
🇮🇪Limerick, Ireland
Evangelische Lungenklinik Berlin ( Site 0274)
🇩🇪Berlin, Germany
Asan Medical Center ( Site 0701)
🇰🇷Seoul, Korea, Republic of
ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)
🇮🇹Milan, Milano, Italy
National Cancer Center ( Site 0702)
🇰🇷Gyeonggi-do, Kyonggi-do, Korea, Republic of
Hiroshima University Hospital ( Site 0762)
🇯🇵Hiroshima, Japan
University Malaya Medical Centre ( Site 0781)
🇲🇾Kuala Lumpur, Malaysia
Hospital de la Santa Creu i Sant Pau ( Site 0385)
🇪🇸Barcelona, Spain
Samsung Medical Center ( Site 0704)
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Vall d Hebron ( Site 0389)
🇪🇸Barcelona, Spain
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)
🇵🇱Poznan, Wielkopolskie, Poland
Hospital Virgen del Rocio ( Site 0387)
🇪🇸Sevilla, Spain
Spitalul Sf. Constantin ( Site 0512)
🇷🇴Brasov, Romania
Wilgers Oncology Centre ( Site 0573)
🇿🇦Pretoria, Gauteng, South Africa
Royal Marsden NHS Foundation Trust ( Site 0458)
🇬🇧London, London, City Of, United Kingdom
Freeman Hospital ( Site 0444)
🇬🇧Newcastle upon Tyne, United Kingdom
Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)
🇪🇸Girona, La Coruna, Spain
Chang Gung Medical Foundation.Linkou Branch ( Site 0723)
🇨🇳Taoyuan, Taiwan
Royal Marsden Hospital ( Site 0457)
🇬🇧Sutton, London, City Of, United Kingdom
Heartlands Hospital in Birmingham ( Site 0455)
🇬🇧Birmingham, United Kingdom
Tri-Service General Hospital ( Site 0726)
🇨🇳Taipei, Taiwan
Boston Medical Center ( Site 0057)
🇺🇸Boston, Massachusetts, United States
St Joseph Heritage Healthcare ( Site 0040)
🇺🇸Santa Rosa, California, United States
Miami Cancer Institute-Baptist Hospital ( Site 0068)
🇺🇸Miami, Florida, United States
Southeastern Regional Medical Center ( Site 0051)
🇺🇸Newnan, Georgia, United States
Western Regional Medical Center, Inc. ( Site 0050)
🇺🇸Goodyear, Arizona, United States
Pacific Cancer Medical Center, Inc. ( Site 0004)
🇺🇸Anaheim, California, United States
Ashland-Bellefonte Cancer Center ( Site 0021)
🇺🇸Ashland, Kentucky, United States
UMass Memorial Medical Center ( Site 0030)
🇺🇸Worcester, Massachusetts, United States
Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Cancer Specialists, PC ( Site 0080)
🇺🇸Fairfax, Virginia, United States
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)
🇦🇷San Juan, Argentina
UZ Leuven ( Site 0221)
🇧🇪Leuven, Vlaams-Brabant, Belgium
AZ Delta ( Site 0222)
🇧🇪Roeselare, West-Vlaanderen, Belgium
Hospital Nossa Senhora da Conceicao ( Site 0145)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Princess Margaret Cancer Centre ( Site 0109)
🇨🇦Toronto, Ontario, Canada
SA Pohja-Eesti Regionaalhaigla ( Site 1100)
🇪🇪Tallinn, Harjumaa, Estonia
Klinikum Esslingen GmbH ( Site 0875)
🇩🇪Esslingen, Baden-Wurttemberg, Germany
Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)
🇩🇪Koblenz, Rheinland-Pfalz, Germany
Universitaetsklinikum Schleswig Holstein ( Site 0871)
🇩🇪Kiel, Schleswig-Holstein, Germany
Zentralklinik Bad Berka GmbH ( Site 0264)
🇩🇪Bad Berka, Thuringen, Germany
IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)
🇮🇹Meldola, Forli-Cesena, Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0311)
🇮🇹Roma, Italy
Tokyo Medical University Hospital ( Site 0771)
🇯🇵Tokyo, Japan
National Cancer Center Hospital ( Site 0767)
🇯🇵Tokyo, Japan
SMG-SNU Boramae Medical Center ( Site 0707)
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea St. Vincent s Hospital ( Site 0705)
🇰🇷Gyeonggi-do, Kyonggi-do, Korea, Republic of
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Dolnoslaskie Centrum Onkologii. ( Site 0491)
🇵🇱Wroclaw, Dolnoslaskie, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)
🇵🇱Lodz, Lodzkie, Poland
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)
🇷🇴Cluj Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)
🇷🇴Craiova, Dolj, Romania
Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)
🇷🇴Suceava, Romania
N.N. Blokhin NMRCO ( Site 0521)
🇷🇺Moscow, Moskva, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)
🇷🇺Kazan, Tatarstan, Respublika, Russian Federation
Wits Clinical Research ( Site 0570)
🇿🇦Parktown-Johannesburg, Gauteng, South Africa
Hospital Universitario Insular de Gran Canaria ( Site 0383)
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
National Cancer Institute of the MoH of Ukraine ( Site 0605)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
MI Odessa Regional Oncological Centre ( Site 0608)
🇺🇦Odesa, Odeska Oblast, Ukraine
Tianjin Medical University General Hospital ( Site 0806)
🇨🇳Tianjin, Anhui, China
Beijing Cancer Hospital ( Site 0811)
🇨🇳Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)
🇨🇳Beijing, Beijing, China
Hunan Cancer Hospital ( Site 0815)
🇨🇳Changsha, Hunan, China
Peking University Third Hospital ( Site 0812)
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital ( Site 0809)
🇨🇳Beijing, Beijing, China
Sun Yat-Sen University Cancer Center ( Site 0816)
🇨🇳Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Center ( Site 0813)
🇨🇳Shanghai, Shanghai, China
Tang Du Hospital ( Site 0803)
🇨🇳XI An, Shanxi, China
Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)
🇨🇳Ningbo, Zhejiang, China
The First Affiliated Hospital of Zhejiang University ( Site 0804)
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital.... ( Site 0814)
🇨🇳Hangzhou, Zhejiang, China
The Oncology Centre ( Site 0571)
🇿🇦Durban, Kwazulu-Natal, South Africa
Liga Norte Riograndense Contra o Cancer ( Site 0150)
🇧🇷Natal, Rio Grande Do Norte, Brazil
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)
🇧🇷Brasilia, Distrito Federal, Brazil
MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)
🇺🇦Kherson, Khersonska Oblast, Ukraine
LungenClinic Grosshansdorf GmbH ( Site 0267)
🇩🇪Grosshansdorf, Schleswig-Holstein, Germany
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Banner MD Anderson Cancer Center ( Site 0028)
🇺🇸Gilbert, Arizona, United States
Sanatorio Allende ( Site 0129)
🇦🇷Cordoba, Argentina
YNOVA Pesquisa Clinica ( Site 0823)
🇧🇷Florianopolis, Santa Catarina, Brazil
Hartford Hospital ( Site 0069)
🇺🇸Hartford, Connecticut, United States
University of Arizona Cancer Center ( Site 0012)
🇺🇸Tucson, Arizona, United States
Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)
🇮🇹Napoli, Campania, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0314)
🇮🇹Rozzano, Lombardia, Italy
Azienda Ospedaliera San Gerardo ( Site 0308)
🇮🇹Monza, Monza E Brianza, Italy
AOU San Luigi Gonzaga di Orbassano ( Site 0313)
🇮🇹Orbassano, Torino, Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)
🇮🇹Brescia, Italy
Hyogo Cancer Center ( Site 0764)
🇯🇵Akashi, Hyogo, Japan
Fukushima Medical University Hospital ( Site 0772)
🇯🇵Fukushima, Japan
S C Pelican Impex SRL ( Site 0506)
🇷🇴Oradea, Bihor, Romania
Helen F. Graham Cancer Center & Research Institute ( Site 0015)
🇺🇸Newark, Delaware, United States
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)
🇺🇸Basking Ridge, New Jersey, United States
Nouvel Hopital Civil ( Site 0255)
🇫🇷Strasbourg, Bas-Rhin, France
Hospital Provincial del Centenario ( Site 0131)
🇦🇷Rosario, Santa Fe, Argentina
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)
🇺🇸Middletown, New Jersey, United States
Hospital Privado de Comunidad. ( Site 0130)
🇦🇷Mar del Plata, Buenos Aires, Argentina
AZ Sint-Maarten ( Site 0226)
🇧🇪Mechelen, Antwerpen, Belgium
McGill University Health Centre ( Site 0111)
🇨🇦Montreal, Quebec, Canada
Cork University Hospital ( Site 0452)
🇮🇪Wilton, Cork, Ireland
Aichi Cancer Center Hospital ( Site 0765)
🇯🇵Nagoya, Aichi, Japan
HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)
🇯🇵Kitakyushu, Fukuoka, Japan
MSKCC-Bergen ( Site 0075)
🇺🇸Montvale, New Jersey, United States
Saint Francis Cancer Center ( Site 0096)
🇺🇸Greenville, South Carolina, United States
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)
🇧🇪Liège, Liege, Belgium
CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)
🇨🇦Chicoutimi, Quebec, Canada
Sanatorio Parque ( Site 0135)
🇦🇷Rosario, Santa Fe, Argentina
S.C.Focus Lab Plus S.R.L ( Site 0513)
🇷🇴Bucuresti, Romania
Hopital Foch ( Site 0243)
🇫🇷Suresnes, Ain, France
Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)
🇫🇷Chambery, Savoie, France
CHU de Rouen ( Site 0252)
🇫🇷Rouen, Seine-Maritime, France
H.I.A. Sainte-Anne ( Site 0251)
🇫🇷Toulon, Var, France
Centre Hospitalier Annecy Genevois ( Site 0242)
🇫🇷Pringy, Savoie, France
Pauls Stradins Clinical University Hospital ( Site 0911)
🇱🇻Riga, Latvia
Nacionalinis Vezio Institutas ( Site 0931)
🇱🇹Vilnius, Lithuania
SC Radiotherapy Center Cluj SRL ( Site 0509)
🇷🇴Comuna Floresti, Cluj, Romania
S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)
🇷🇴Otopeni, Ilfov, Romania
S C Oncocenter Oncologie Medicala S R L ( Site 0505)
🇷🇴Timisoara, Timis, Romania
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 0388)
🇪🇸L Hospitalet De Llobregat, Barcelona, Spain
Cherkassy Regional Oncological Center ( Site 0613)
🇺🇦Cherkasy, Cherkaska Oblast, Ukraine
Istituto Nazionale Tumori ( Site 0309)
🇮🇹Milano, Abruzzo, Italy
LSMUL Kauno Klinikos ( Site 0932)
🇱🇹Kaunas, Lithuania
Centrul Medical Medicover Victoria ( Site 0514)
🇷🇴Bucharest, Bucuresti, Romania
Euroclinic Hospital Bucharest ( Site 0510)
🇷🇴Bucuresti, Romania
Sarawak General Hospital ( Site 0782)
🇲🇾Kuching, Sarawak, Malaysia
St. Marianna University School of Medicine Hospital ( Site 0769)
🇯🇵Kawasaki, Kanagawa, Japan
Kanagawa Cancer Center ( Site 0763)
🇯🇵Yokohama, Kanagawa, Japan
Oita University Hospital ( Site 0766)
🇯🇵Yufu, Oita, Japan
Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)
🇵🇱Prabuty, Pomorskie, Poland
China Medical University Hospital ( Site 0724)
🇨🇳Taichung, Taiwan
Juntendo University Hospital ( Site 0768)
🇯🇵Tokyo, Japan
Riga East Clinical University Hospital ( Site 0912)
🇱🇻Riga, Latvia
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)
🇵🇱Bystra, Dolnoslaskie, Poland
National Medical Research Radiology Centre ( Site 0535)
🇷🇺Moscow, Moskva, Russian Federation
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)
🇷🇴Cluj-Napoca, Cluj, Romania
Spitalul clinic Judetean de urgenta Constanta ( Site 0508)
🇷🇴Constanta, Romania
Medical Rehabilitation Center ( Site 0534)
🇷🇺Moscow, Moskva, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 0524)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Cape Town Oncology Trials Pty Ltd ( Site 0572)
🇿🇦Kraaifontein, Western Cape, South Africa
Municipal Clinical Oncology Center ( Site 0523)
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Kaohsiung Chang Gung Memorial Hospital ( Site 0725)
🇨🇳Kaohsiung, Taiwan
Tomsk Scientific Research Institute of Oncology ( Site 0526)
🇷🇺Tomsk, Tomskaya Oblast, Russian Federation
Kyiv City Clinical Oncological Center ( Site 0601)
🇺🇦Kyiv, Kyivska Oblast, Ukraine
Leicester Royal Infirmary ( Site 0447)
🇬🇧Leicester, Leicestershire, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)
🇬🇧Wirral, Liverpool, United Kingdom
Nottingham City Hospital Campus ( Site 0441)
🇬🇧Nottingham, Nottinghamshire, United Kingdom
National Taiwan University Hospital ( Site 0721)
🇨🇳Taipei, Taiwan
PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)
🇺🇦Kropyvnytsky, Kirovohradska Oblast, Ukraine
Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)
🇺🇦Zaporizhzhya, Zaporizka Oblast, Ukraine
Plymouth Hospitals NHS Trust ( Site 0443)
🇬🇧Plymouth, United Kingdom
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)
🇧🇷Barretos, Sao Paulo, Brazil
Hospital General Universitario Gregorio Maranon ( Site 0382)
🇪🇸Madrid, Spain
Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)
🇺🇸Uniondale, New York, United States
White Plains Hospital Center for Cancer Care ( Site 0007)
🇺🇸White Plains, New York, United States
University of Iowa Hospital and Clinics ( Site 0010)
🇺🇸Iowa City, Iowa, United States
Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)
🇺🇸Lansing, Michigan, United States
Allegheny General Hospital ( Site 0009)
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System ( Site 0052)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Pinnacle Health System - East Location ( Site 0063)
🇺🇸Harrisburg, Pennsylvania, United States
Emily Couric Clinical Cancer Center ( Site 0013)
🇺🇸Charlottesville, Virginia, United States
Inova Schar Cancer Institute ( Site 0032)
🇺🇸Fairfax, Virginia, United States
Providence Regional Cancer Partnership ( Site 0065)
🇺🇸Everett, Washington, United States
Hôpital Avicenne - Service d oncologie medicale ( Site 0249)
🇫🇷Bobigny, Seine-Saint-Denis, France
Taipei Veterans General Hospital ( Site 0722)
🇨🇳Taipei, Taiwan
University of Arizona Cancer Center - Dignity Health ( Site 0062)
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System ( Site 0031)
🇺🇸Detroit, Michigan, United States
Mayo Clinic ( Site 0026)
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center ( Site 0047)
🇺🇸Omaha, Nebraska, United States
OHSU Center for Health & Healing ( Site 1006)
🇺🇸Portland, Oregon, United States
Southwestern Regional Medical Center, Inc. ( Site 0054)
🇺🇸Tulsa, Oklahoma, United States
Harry & Jeanette Weinberg Cancer Institute ( Site 0081)
🇺🇸Baltimore, Maryland, United States
Montefiore Einstein Center ( Site 0016)
🇺🇸Bronx, New York, United States
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)
🇪🇸Badalona, Barcelona, Spain
MI Precarpathian Clinical Oncology Center ( Site 0603)
🇺🇦Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
City Clinical Hosp.4 of DCC ( Site 0607)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Zhongshan Hospital of Fudan University ( Site 0808)
🇨🇳Shanghai, Shanghai, China
Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)
🇨🇳Shanghai, Shanghai, China