Clinical trial NCT06627647: A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
Official title: A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non-squamous Non-small Cell Lung Cancer
Keywords: ARTEMIDE-Lung03
Rilvegostomig (AZD2936)
Non-squamous non-small cell lung cancer (NSCLC)
Bi-specific antibody
T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)
EGFR, ALK and ROS1 testing
Programmed cell death protein (PD-L1)
Pembrolizumab
Carboplatin
Cisplatin
Pemetrexed
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A: Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.

Arm B: Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
Primary purpose: TREATMENT

Brief summary: The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.

Detailed description: This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented non-squamous NSCLC.
* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
* Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
* Adequate organ and bone marrow function

Exclusion Criteria:

* Presence of small cell and neuroendocrine histology components.
* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
* Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of treatment.
* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
* Active primary immunodeficiency/active infectious disease(s).
* Active tuberculosis infection.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to approximately 5 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Landmark overall survival (OS) rates
timeFrame: Up to approximately 5 years
measure: Landmark progression-free survival (PFS) rates
timeFrame: Up to approximately 5 years
measure: Time to second progression or death (PFS2)
timeFrame: Up to approximately 5 years
measure: Overall response rate (ORR)
timeFrame: Up to approximately 5 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 5 years
measure: Pharmacokinetic (PK) of rilvegostomig
timeFrame: Up to approximately 5 years
measure: Immunogenicity of rilvegostomig
timeFrame: Up to approximately 5 years
measure: Patient-reported physical functioning
timeFrame: Up to approximately 5 years
measure: Patient-reported global health status (GHS)/quality of life (QoL)
timeFrame: Up to approximately 5 years
measure: Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
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state: California
city: San Francisco
country: United States
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state: California
city: Santa Rosa
country: United States
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state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Lone Tree
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
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state: Connecticut
city: West Haven
country: United States
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state: Connecticut
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Bay Pines
country: United States
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state: Florida
city: Fort Lauderdale
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Jacksonville
country: United States
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city: Miami
country: United States
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city: Ocala
country: United States
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city: Saint Petersburg
country: United States
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city: Atlanta
country: United States
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state: Georgia
city: Boise
country: United States
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Decatur
country: United States
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state: Illinois
city: Quincy
country: United States
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state: Illinois
city: Waterloo
country: United States
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state: Iowa
city: Lexington
country: United States
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state: Kentucky
city: Lexington
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Alexandria
country: United States
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state: Louisiana
city: Baton Rouge
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: South Portland
country: United States
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state: Maine
city: Baltimore
country: United States
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state: Maryland
city: Grand Rapids
country: United States
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state: Michigan
city: Duluth
country: United States
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state: Minnesota
city: Rochester
country: United States
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city: Saint Paul
country: United States
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state: Minnesota
city: Bridgeton
country: United States
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state: Missouri
city: Columbia
country: United States
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state: Missouri
city: Lincoln
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state: Nebraska
city: Camden
country: United States
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state: New Jersey
city: Buffalo
country: United States
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state: New York
city: Westbury
country: United States
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state: New York
city: Canton
country: United States
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state: Ohio
city: Medford
country: United States
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state: Oregon
city: Portland
country: United States
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city: Salem
country: United States
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state: Oregon
city: Pittsburgh
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state: Pennsylvania
city: York
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state: Pennsylvania
city: Providence
country: United States
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state: Rhode Island
city: Pierre
country: United States
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state: South Dakota
city: Sioux Falls
country: United States
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state: South Dakota
city: Chattanooga
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Fort Worth
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Kingwood
country: United States
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state: Texas
city: Lubbock
country: United States
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state: Texas
city: Palestine
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state: Texas
city: Round Rock
country: United States
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state: Texas
city: Fairfax
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state: Virginia
city: Norfolk
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city: Roanoke
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state: Virginia
city: Seattle
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state: Washington
city: Seattle
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state: Washington
city: Silverdale
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Wenatchee
country: United States
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state: Washington
city: La Crosse
country: United States
facility: Research Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Research Site
city: Caba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Pilar
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Darlinghurst
country: Australia
facility: Research Site
city: Hyde Park
country: Australia
facility: Research Site
city: Southport
country: Australia
facility: Research Site
city: Wollongong
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Ijuí
country: Brazil
facility: Research Site
city: Londrina
country: Brazil
facility: Research Site
city: Passo Fundo
country: Brazil
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city: Porto Alegre
country: Brazil
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city: Salvador
country: Brazil
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city: Sao Paulo
country: Brazil
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city: São Paulo
country: Brazil
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city: São Paulo
country: Brazil
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city: Taubaté
country: Brazil
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city: Vitoria
country: Brazil
facility: Research Site
city: Saint John
country: Canada
facility: Research Site
state: New Brunswick
city: Sydney
country: Canada
facility: Research Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Montréal
country: Canada
facility: Research Site
state: Quebec
city: St-Jerome
country: Canada
facility: Research Site
state: Quebec
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
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city: Changsha
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
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city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
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city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Jingzhou
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Linhai
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Ningbo
country: China
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city: Shanghai
country: China
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city: Shanghai
country: China
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city: Wenzhou
country: China
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city: Wuhan
country: China
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city: Xi'an
country: China
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city: Xiangyang
country: China
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city: Zhengzhou
country: China
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city: Zhengzhou
country: China
facility: Research Site
city: Avignon
country: France
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city: La Rochelle Cedex
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Nîmes Cedex 9
country: France
facility: Research Site
city: Rennes
country: France
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city: Strasbourg
country: France
facility: Research Site
city: Suresnes
country: France
facility: Research Site
city: Toulon Cedex 9
country: France
facility: Research Site
city: Bad Berka
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Esslingen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Giessen
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyöngyös
country: Hungary
facility: Research Site
city: Győr
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Székesfehérvár
country: Hungary
facility: Research Site
city: Törökbálint
country: Hungary
facility: Research Site
city: Calicut
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Madurai
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Nashik
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Varanasi
country: India
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Peschiera Del Garda
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Amagasaki-shi
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Kawagoe-shi
country: Japan
facility: Research Site
city: Kitaadachi-gun
country: Japan
facility: Research Site
city: Kitakyushu-shi
country: Japan
facility: Research Site
city: Kobe-shi
country: Japan
facility: Research Site
city: Koto-ku
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Matsusaka-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Ota-shi
country: Japan
facility: Research Site
city: Saitama-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Sunto-gun
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Songpa-gu
country: Korea, Republic of
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuching
country: Malaysia
facility: Research Site
city: Petaling Jaya
country: Malaysia
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Ede
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Leidschendam
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Biała Podlaska
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bystra
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Castellón
country: Spain
facility: Research Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Majadahonda
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: New Taipei City
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Dusit
country: Thailand
facility: Research Site
city: Nakhon Ratchasima
country: Thailand
facility: Research Site
city: Songkla
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Edirne
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Seyhan
country: Turkey
facility: Research Site
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Greater London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
city: Can Tho
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Vinh
country: Vietnam
facility: Research Site
Study officials:
References: