A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer

Phase 3

Active, not recruiting

• Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
• Interventions: Drug: placebo; Drug: zolbetuximab; Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil

• Registration Number: NCT03504397
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric...

Detailed Description

The study consists of the following periods: screening; treatment; post-treatment follow up, safety follow up, long term and survival follow-up. After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Study Start: 2018-06-21
• Primary Completion: 2022-09-09
• Disposition First Submitted: 2023-09-07
• Disposition First Posted: 2023-09-13
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-07
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 566

Inclusion Criteria

• Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

  • Not a woman of child-bearing potential (WOCBP) OR
  • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs

• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.

• Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.

• A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration.

• Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration.

• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration.

• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.

• Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.

• Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.

• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.

• Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)

• Subject has ECOG performance status 0 to 1.

• Subject has predicted life expectancy ≥ 12 weeks.

• Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

  • Hemoglobin (Hgb) ≥ 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Albumin ≥ 2.5 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
  • Estimated creatinine clearance ≥ 30 mL/min
  • Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

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Exclusion Criteria

• Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization.

• Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.

• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.

• Subject has received other investigational agents or devices within 28 days prior to randomization.

• Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.

• Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.

• Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.

• Subject has known dihydropyrimidine dehydrogenase deficiency.

• Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.

• Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.

• Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

  • For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
  • Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
  • Subjects treated for HCV with undetectable viral load results are eligible.

• Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.

• Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.

• Subject has significant cardiovascular disease, including any of the following:

  • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
  • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes)
  • QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
  • History or family history of congenital long QT syndrome
  • Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).

• Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.

• Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.

• Subject has had a major surgical procedure ≤ 28 days prior to randomization.

  • Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.

• Subject has psychiatric illness or social situations that would preclude study compliance.

• Subject has another malignancy for which treatment is required.

• Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (Placebo plus mFOLFOX6)	placebo	Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm A (zolbetuximab plus mFOLFOX6)	zolbetuximab	Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm A (zolbetuximab plus mFOLFOX6)	oxaliplatin	Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm A (zolbetuximab plus mFOLFOX6)	folinic acid	Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm B (Placebo plus mFOLFOX6)	oxaliplatin	Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm A (zolbetuximab plus mFOLFOX6)	fluorouracil	Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm B (Placebo plus mFOLFOX6)	fluorouracil	Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Arm B (Placebo plus mFOLFOX6)	folinic acid	Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to 13 months	PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest.

Secondary Outcome Measures

Name	Time	Method
Duration Of Response (DOR)	Up to 13 months	DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.
Number of participants with vital signs abnormalities and or adverse events	Up to 14 months	Number of participants with potentially clinically significant vital sign values.
Overall Survival (OS)	Up to 23 months	OS is defined as the time from the date of randomization until the date of death from any cause.
Objective Response Rate (ORR)	Up to 13 months	ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1.
Safety and tolerability assessed by adverse events (AEs)	Up to 16 months	An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of participants with laboratory assessments abnormalities and or adverse events	Up to 14 months	Number of participants with potentially clinically significant laboratory values.
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events	Up to 14 months	Number of participants with potentially clinically significant ECG values.
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events	Up to 13 months	Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work;...
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire	Up to 16 months	The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive.
HRQoL measured by the QLQ-OG25 questionnaire	Up to 16 months	The EORTC-QLQ-OG25 instrument evaluates Gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion.
HRQoL measured by the Global Pain (GP) questionnaire	Up to 16 months	The GP instrument is a single assessment of overall pain.
HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire	Up to 16 months	The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension...
Time to confirmed deterioration (TTCD)	Up to 16 months	Calculated using the physical function (PF), OG25-Pain and Global Health Status (GHS)/QoL scores as measured by EORTC QLQ-C30 and QLQ-OG25. TTCD is defined as time to first confirmed deterioration (time from randomization to first clinically meaningful deterioration that is confirmed at the next scheduled visit).
PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)	Up to 16 months	Ctrough will be derived from the PK serum samples collected.
Number of anti-drug antibody (ADA) Positive Participants	Up to 16 months	Immunogenicity will be measured by the number of participants that are ADA positive.

Trial Locations

Locations (214)

St. Jude Hospital Yorba Linda; 🇺🇸 Fullerton, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Site CN86001; 🇨🇳 Xiamen, China

University of California - San Francisco; 🇺🇸 San Francisco, California, United States

Site BR55010; 🇧🇷 Brasília, Distrito Federal, Brazil

Site TW88605; 🇨🇳 Kwei-Shan, Taoyuan, Taiwan

Site BR55006; 🇧🇷 Lajeado, Rio Grande Do Sul, Brazil

University of Oklahoma Health Science Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Site FR33011; 🇫🇷 Montpellier Cedex 5, Languedoc-Roussillon, France

University of Arizona; 🇺🇸 Phoenix, Arizona, United States

CBCC Global Research, Inc. at Comprehensive Blood and Cancer; 🇺🇸 Bakersfield, California, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

Pacific Shores Medical Group; 🇺🇸 Huntington Beach, California, United States

Northwestern University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Maryland Medical Center(UMMC)Transplant Center; 🇺🇸 Baltimore, Maryland, United States

Maryland Oncology Hematology; 🇺🇸 Brandywine, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Earle A. Chiles Research Institute; 🇺🇸 Portland, Oregon, United States

Sanford Cancer Center; 🇺🇸 Sioux Falls, South Dakota, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Site AU61002; 🇦🇺 Douglas, Queensland, Australia

Site BE32007; 🇧🇪 Edegem, Antwerpen, Belgium

Site BE32001; 🇧🇪 Bruxelles, Bruxelles-Capitale, Région De, Belgium

Site BE32002; 🇧🇪 Bruxelles, Liege, Belgium

Site BE32012; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Site BE32010; 🇧🇪 Haine-Saint-Paul, Belgium

Site BE32005; 🇧🇪 Brugge, Belgium

Site BR55017; 🇧🇷 Belo Horizonte, Brazil

Site BR55016; 🇧🇷 Passo Fundo, Brazil

Site BR55018; 🇧🇷 Santa Catarina, Brazil

Site BR55009; 🇧🇷 São Paulo, Brazil

Site BR55004; 🇧🇷 São Paulo, Brazil

Site DE49011; 🇩🇪 Berlin, Germany

Site CA15005; 🇨🇦 Edmonton, Alberta, Canada

Site IT39008; 🇮🇹 Milano, Italy

Site CA15011; 🇨🇦 Toronto, Ontario, Canada

Site CA15002; 🇨🇦 Montreal, Quebec, Canada

Site CA15008; 🇨🇦 Montreal, Quebec, Canada

Site CL56008; 🇨🇱 Providencia, Chile

Site CL56005; 🇨🇱 Santiago, Chile

Site CN86006; 🇨🇳 Nanjing, Jiangsu, China

Site CN86009; 🇨🇳 Beijing, China

Site CN86004; 🇨🇳 Hangzhou Shi, Zhejiang, China

Site CN86005; 🇨🇳 Hefei, China

Site CN86002; 🇨🇳 Beijing, China

Site CN86008; 🇨🇳 Zhengzhou, China

Site FR33008; 🇫🇷 Besancon cedex, Franche-Comte, France

Site DE49019; 🇩🇪 Heilbronn, Germany

Site FR33103; 🇫🇷 Creteil, France

Site FR33003; 🇫🇷 Lyon, Rhone, France

Site FR33104; 🇫🇷 Saint Priest en Jarez, France

Site DE49007; 🇩🇪 Munchen, Bayern, Germany

Site DE49021; 🇩🇪 Halle, Sachsen-Anhalt, Germany

Site DE49002; 🇩🇪 Mainz, Rheinland-Pfalz, Germany

Site DE49012; 🇩🇪 Berlin, Germany

Site DE49015; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Site DE49004; 🇩🇪 Leipzig, Sachsen, Germany

Site DE49010; 🇩🇪 Dresden, Sachsen, Germany

Site IL97210; 🇮🇱 HaDarom, Israel

Site IL97206; 🇮🇱 Kfar Saba, HaMerkaz, Israel

Site IT39011; 🇮🇹 Meldola, Forli, Italy

Site IL97203; 🇮🇱 Tel Aviv, Israel

Site IL97202; 🇮🇱 Jerusalem, Israel

Site IT39023; 🇮🇹 Vicenza, VI, Italy

Site IT39020; 🇮🇹 Monza, Lombardia, Italy

Site IT39013; 🇮🇹 Ancona, Italy

Site IT39004; 🇮🇹 Bergamo, Italy

Site IT39009; 🇮🇹 Cremona, Italy

Site IT39021; 🇮🇹 Modena, Italy

Site IT39016; 🇮🇹 Padova, Italy

Site IT39018; 🇮🇹 Perugia, Italy

Site IT39019; 🇮🇹 Pisa, Italy

Site IT39015; 🇮🇹 Roma, Italy

Site IT39024; 🇮🇹 Turin TO, Italy

Site JP81003; 🇯🇵 Kashiwa, Chiba, Japan

Site JP81014; 🇯🇵 Kobe, Hyogo, Japan

Site JP81001; 🇯🇵 Suita, Osaka, Japan

Site JP81015; 🇯🇵 Hidaka, Saitama, Japan

Site JP81012; 🇯🇵 Sunto-gun, Shizuoka, Japan

Site JP81010; 🇯🇵 Kitaadachi-gun, Saitama, Japan

Site JP81008; 🇯🇵 Koto-ku, Tokyo, Japan

Site JP81005; 🇯🇵 Fukuoka, Japan

Site JP81004; 🇯🇵 Osaka, Japan

Site KR82003; 🇰🇷 Seoul, Korea, Republic of

Site KR82008; 🇰🇷 Incheon, Korea, Republic of

Site KR82006; 🇰🇷 Seoul, Korea, Republic of

Site MX52007; 🇲🇽 Ciudad de México, Distrito Federal, Mexico

Site MX52001; 🇲🇽 Aguascalientes, Mexico

Site MX52004; 🇲🇽 Oaxaca, Mexico

Site PE51003; 🇵🇪 Arequipa, Peru

Site PE51005; 🇵🇪 Lima, Peru

Site PE51001; 🇵🇪 Lima, Peru

Site PL48009; 🇵🇱 Warszawa, Poland

Site PL48002; 🇵🇱 Brzozow, Podkarpackie, Poland

Site ES34016; 🇪🇸 Barcelona, Spain

Site ES34019; 🇪🇸 Burgos, Spain

Site ES34015; 🇪🇸 Barcelona, Spain

Site ES34003; 🇪🇸 Murcia, Spain

Site ES34008; 🇪🇸 Madrid, Spain

Site ES34017; 🇪🇸 Madrid, Spain

Site TW88608; 🇨🇳 Kaohsiung, Taiwan

Site TW88603; 🇨🇳 Taichung, Taiwan

Site GB44101; 🇬🇧 London, London, City Of, United Kingdom

Site GB44102; 🇬🇧 Sutton, Surrey, United Kingdom

Site GB44103; 🇬🇧 Cambridge, United Kingdom

Site GB44004; 🇬🇧 London, United Kingdom

Site GB44002; 🇬🇧 London, United Kingdom

Site GB44008; 🇬🇧 Leeds, United Kingdom

Site GB44001; 🇬🇧 Manchester, United Kingdom

Site ES34011; 🇪🇸 Alcorcon, Madrid, Spain

Site ES34004; 🇪🇸 Madrid, Spain

Site KR82005; 🇰🇷 Seoul, Korea, Republic of

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Health Partners Institute; 🇺🇸 Saint Louis Park, Minnesota, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

MultiCare Regional Cancer Center - Gig Harbor; 🇺🇸 Auburn, Washington, United States

Site AU61007; 🇦🇺 Kogarah, Australia

Inova Dwight and Martha Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 Uniondale, New York, United States

City of Hope Nat'l Medical Center; 🇺🇸 Duarte, California, United States

The University of Arizona Medical Center; 🇺🇸 Tucson, Arizona, United States

Memorial Cancer Institute - West; 🇺🇸 Hollywood, Florida, United States

Memorial Hospital West; 🇺🇸 Pembroke Pines, Florida, United States

Cancer Treatment Centers of America, Atlanta; 🇺🇸 Newnan, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Lancaster General Hospital; 🇺🇸 Lancaster, Pennsylvania, United States

Cancer Treatment Centers of America, Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Rhode Island Hospital-Lifespan Cancer Institute; 🇺🇸 Providence, Rhode Island, United States

Site AU61011; 🇦🇺 Tugun, Queensland, Australia

Site AU61008; 🇦🇺 Adelaide, South Australia, Australia

Site AU61006; 🇦🇺 East Bentleigh, Victoria, Australia

Site BE32004; 🇧🇪 Brussels, Belgium

Site BE32006; 🇧🇪 Leuven, Vlaams Brabant, Belgium

Site BE32011; 🇧🇪 Charleroi, Belgium

Site BR55002; 🇧🇷 Itajai, Santa Catarina, Brazil

Site BR55003; 🇧🇷 Santo Andre, Sao Paulo, Brazil

Site BR55005; 🇧🇷 Sao Jose do Rio Preto, Sao Paulo, Brazil

Site BR55015; 🇧🇷 Rio de Janeiro, Brazil

Site CA15009; 🇨🇦 Saint-John, New Brunswick, Canada

Site CL56007; 🇨🇱 Valdivia, Chile

Site CN86003; 🇨🇳 Haerbin, Heilongjiang, China

Site CO57009; 🇨🇴 Bogota, DC, Colombia

Site CO57005; 🇨🇴 Cali, Valle, Colombia

Site CO57002; 🇨🇴 Medellin, Colombia

Site FR33001; 🇫🇷 Rennes, Bretagne, France

Site FR33009; 🇫🇷 Dijon, Bourgogne, France

Site FR33010; 🇫🇷 Brest Cedex, Bretagne, France

Site FR33005; 🇫🇷 Nice, Provence-Alpes-Côte-d'Azur, France

Site FR33002; 🇫🇷 Paris cedex, Paris, France

Site FR33101; 🇫🇷 St Herblain, Pays-de-la-Loire, France

Site FR33007; 🇫🇷 Nice Cedex 2, France

Site FR33006; 🇫🇷 Poitiers, Vienne, France

Site DE49018; 🇩🇪 Dresden, Germany

Site IL97201; 🇮🇱 Haifa, Israel

Site IL97209; 🇮🇱 Holon, Israel

Site IT39006; 🇮🇹 Milano, Italy

Site IT39012; 🇮🇹 Parma, Italy

Site IT39003; 🇮🇹 Piacenza, Italy

Site IT39022; 🇮🇹 Reggio Emilia, Italy

Site IT39026; 🇮🇹 Terni, Italy

Site JP81002; 🇯🇵 Matsuyama, Ehime, Japan

Site JP81009; 🇯🇵 Nagoya, Aichi, Japan

Site JP81007; 🇯🇵 Sapporo, Hokkaido, Japan

Site JP81013; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Site JP81011; 🇯🇵 Osaka, Japan

Site KR82002; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Site KR82009; 🇰🇷 Suwon-si, Gyeonggido [Kyonggi-do], Korea, Republic of

Site KR82004; 🇰🇷 Seoul, Seoul Teugbyeolsi, Korea, Republic of

Site KR82007; 🇰🇷 Seoul, Korea, Republic of

Site MX52010; 🇲🇽 Veracruz, Ver, Veracruz, Mexico

Site MX52003; 🇲🇽 Distrito Federal, Mexico

Site PL48004; 🇵🇱 Lublin, Lubuskie, Poland

Site PL48005; 🇵🇱 Wieliszew, Mazowieckie, Poland

Site ES34010; 🇪🇸 Avila, Castilla Y Leon, Spain

Site ES34013; 🇪🇸 Badalona, Barcelona, Spain

Site ES34005; 🇪🇸 Barcelona, Spain

Site ES34018; 🇪🇸 Sevilla, Spain

Site ES34006; 🇪🇸 Zaragoza, Spain

Site TW88604; 🇨🇳 Kaohsiung, Taiwan

Site TW88607; 🇨🇳 Tainan, Taiwan

Site TW88606; 🇨🇳 Taipei, Taiwan

Site TW88601; 🇨🇳 Taipei, Taiwan

Site GB44003; 🇬🇧 Aberdeen, Aberdeenshire, United Kingdom

Site GB44009; 🇬🇧 Coventry, United Kingdom

Site GB44104; 🇬🇧 Dundee, United Kingdom

University of California Davis; 🇺🇸 Sacramento, California, United States

Orlando Health Inc; 🇺🇸 Orlando, Florida, United States

Norton Cancer Institute; 🇺🇸 Louisville, Kentucky, United States

Site CL56003; 🇨🇱 Providencia, Santiago, Chile

Site DE49008; 🇩🇪 Munich, Bavaria, Germany

Site MX52008; 🇲🇽 San Luis De Potosi, Mexico

Site CO57006; 🇨🇴 Medellín, Antioquia, Colombia

Site PL48007; 🇵🇱 Ostroleka, Mazowieckie, Poland

Site PE51006; 🇵🇪 Lima, Peru

Site PE51004; 🇵🇪 San Isidro, Lima, Peru

Site CO57007; 🇨🇴 Monteria, Córdoba, Colombia

Site MX52002; 🇲🇽 Mexico, Distrito Federal, Mexico

Site BE32008; 🇧🇪 Mons, Hainaut, Belgium

Site CO57001; 🇨🇴 Cali, Colombia

Site JP81006; 🇯🇵 Chuo-ku, Tokyo, Japan

Site MX52009; 🇲🇽 Jalisco, Mexico

Site BR55007; 🇧🇷 Barretos, São Paulo, Brazil

Precision Cancer Research -Dayton Physicians Network; 🇺🇸 Middletown, Ohio, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States