Clinical trial NCT04338399: The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC
Official title: The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: Buparlisib
PD1
PDL1
Lead sponsor: Adlai Nortye Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

Detailed description: This study is to assess the impact on overall survival of the combination of Buparlisib and paclitaxel compared to paclitaxel alone in patients with prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years old.
2. Able to provide informed consent obtained before any trial related activities and according to local guidelines.
3. Patient has histologically and/or cytologically-confirmed HNSCC.
4. Patient has archival or new tumor tissue for the analysis of biomarkers and confirmation of HPV status (if unknown). One tumor block (preferred) or a recommended minimum of 5 unstained slides for patients with known HPV status (for tumor DNA characterization) or a recommended minimum of 10 slides for patients whose HPV status is unknown (5 slides for HPV testing plus 5 slides needed for biomarker testing). Enrollment in the study is contingent on confirmation of the availability of an adequate amount of tumor tissue, except in rare special circumstances, which must be reviewed and approved by the sponsor.
5. Patient has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease:

   1. PDLl/PD1 therapy alone for metastatic (monotherapy) disease
   2. PDL1/PD1 in combination with chemotherapy for metastatic and recurrent disease
   3. PDL1/PD1 used for metastatic disease, after or prior to receiving a platinum agent for locally advanced or metastatic disease.
6. 6. Patient has received no more than two prior lines of systemic treatment for HNSCC (single agent chemotherapy used as a radiosensitizer is not counted as a prior line of therapy).
7. Patient has measurable disease as determined per RECIST version 1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a four-week period since radiotherapy completion is required.
8. Patient has adequate bone marrow function and organ function as shown by the following:

   1. Absolute neutrophil count (ANC) ≥1.5 x 109/L.
   2. Hemoglobin ≥9 g/dL (which may be reached by transfusion).
   3. Platelets ≥100 x 109/L (which may be reached by transfusion).
   4. International normalized ratio (INR) ≤1.5.
   5. Calcium (corrected for serum albumin) within normal limits (WNL) or ≤ grade 1 severity according to NCI-CTCAE version 5.0 if judged clinically not significant by the Investigator.

      Patients concomitantly taking bisphosphonates or denosumab for calcium correction are eligible.
   6. Normal potassium and magnesium levels.
   7. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) or \< 3.0 x ULN if liver metastases are present.
   8. Total serum bilirubin ≤ ULN or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis.
   9. Serum creatinine ≤ 1.5 x ULN or calculated and directly measured creatinine clearance (CrCL) \> 30 mL/min.
   10. Haemoglobin A1c (glycosylated hemoglobin; HbA1c) ≤8%.
9. Patient has Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
10. Patient is able to swallow and retain oral medication. Patients able to swallow oral medication but mostly self-nourished through gastric or jejunal feeding tube are eligible.
11. Patients must apply highly effective contraception during and throughout the study, as well after the final dose of study treatment

Exclusion Criteria:

Patients meeting any of the following criteria will not be eligible for participation in the study:

1. Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors.
2. Patient received treatment with a taxane as part of prior treatment for metastatic disease.
3. Patient has symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases may participate in this study. Patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy) and must be on a stable low dose of corticosteroid therapy. Radiosurgery must have been completed at least 14 days prior to start of study treatment.
4. Patient has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment or who have adverse events which have not recovered to grade 1 or better from previous chemotherapy treatment (except alopecia, autoimmune endocrine events must be stable and controlled).
5. Patient has grade ≥ 2 neuropathy, colitis, pneumonitis, , and uncontrolled endocrinopathies (e.g., hypothyroidism, diabetes with hemoglobin A1c \> 8%) from previous treatment
6. Patient has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
7. Patient is currently receiving increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent. The following uses of corticosteroids are permitted: single doses; standard premedication for paclitaxel, topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops, or local injections (e.g., intra-articular), or \< 10 mg prednisolone or equivalent.
8. Patient is being treated at start of study treatment with any of the following drugs:

   1. Drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications (see Table 16).
   2. Drugs with a known risk of inducing Torsades de Pointes. Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is allowed.
9. Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or new oral anticoagulants (NOACs) is allowed.
10. Patient has a known hypersensitivity and/or contraindication to paclitaxel, standard premedication for paclitaxel, or other products containing Cremophor®.
11. Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc).
12. Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory).
13. Patient has any of the following cardiac abnormalities:

    1. Symptomatic congestive heart failure within 12 months of the screening period.
    2. History of documented congestive heart failure (New York Heart Association functional classification III-IV) or documented cardiomyopathy and left ventricular ejection fraction (LVEF) \<50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
    3. Myocardial infarction ≤six months prior to enrollment.
    4. Unstable angina pectoris.
    5. Serious uncontrolled cardiac arrhythmia.
    6. Symptomatic pericarditis.
    7. QT interval corrected according to the formula of Fridericia (QTcF) \> 450 msec for males and \> 470 msec for females, on the screening electrocardiogram (ECG).
    8. Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
14. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
15. Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self or others), or active severe personality disorders (defined according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition \[DSM-V\]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study treatment.
16. Patient has other prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, early gastric or GI cancer resected completely by endoscopy procedures or any other cancer from which the patient has been disease free for ≥ 3years.
17. Patient has a history of non-compliance to any medical regimen or inability to grant consent.
18. Patient is concurrently using or has used another approved or investigational cancer agent within 4 weeks of randomization.
19. Patient is pregnant or nursing (lactating). Patients with elevated human chorionic gonadotrophin (hCG) at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated five to seven days later, or pregnancy has been ruled out by vaginal ultrasound.
20. Patient has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed. Non-live COVID vaccinations or boosters should not occur within 30 days of study start.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Overall survival will be measured from time of randomization until death from any cause. The analysis will occur when all patients have been randomized and followed for 12 months.
Secondary outcomes:
measure: Progression free survival
timeFrame: PFS will be assessed up to 24 months after all patients are randomized
measure: Overall Response Rate
timeFrame: ORR will be assessed for all patients 6 months after randomization is complete.
measure: Health Related Quality of Life (QoL): Time to Definitive deterioration of Quality of Life as assessed by EORTC C30 questionnaire
timeFrame: Assessments will be made from randomization until treatment discontinuation
measure: Safety and Tolerability of Buparlisib in combination with Paclitaxel compared with Paclitaxel alone as Measured by Number of Participants Experiencing Adverse Events (AEs).
timeFrame: From screening until 4 weeks following treatment discontinuation
measure: Pharmacokinetics of Buparlisib: plasma concentration-time profile of Buparlisib during 15 days of treatment
timeFrame: Day 0 to Day 15 sparse sampling
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: New Haven
country: United States
facility: Yale University, Yale Cancer Center
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Tyler
country: United States
facility: Hope Cancer Center, UT Health East Texas
state: Texas
city: Buenos Aires
country: Argentina
facility: Fundacion Cenit para la Investigacion en Neurociencias
city: Buenos Aires
country: Argentina
facility: Centro de Investigacion Pergamino SA - Clinica Pergamino S.A.
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Instituto de Investigaciones Metabólicas (IDIM) // Instituto de Investigaciones Metabólicas S.A.
city: Córdoba
country: Argentina
facility: IONC SRL- Instituto Oncológico de Córdoba
city: La Rioja
country: Argentina
facility: Fundacion CORI para la Investigacion y Prevencion del Cáncer
city: Tucuman
country: Argentina
facility: Centro para la Atencion Integral del Paciente Oncologico - CAIPO
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent UZ Gent
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Liege
country: Belgium
facility: Clinique CHC MontLégia
city: Ottignies
country: Belgium
facility: Clinique Saint-Pierre dOttignies CSPO
city: Montreal
country: Canada
facility: CHUM
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Affiliated Cancer Hospital of Chongqing University
city: Chongqing
country: China
facility: The First Affiliated Hospital of CQMU
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Jinan
country: China
facility: Shandong Provincial Tumor Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Naning
country: China
facility: Cancer Hospital affiliated to Guangxi Medical University
city: Shanghai
country: China
facility: Shanghai Dongfang Hospital
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
city: Bordeaux
country: France
facility: Centre hospitalier Universitaire de Bordeaux
city: Caen
country: France
facility: Centre Franois Baclesse
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital de la Timone
city: Montpellier
country: France
facility: Institut regional du Cancer de Montpellier
city: Nantes
country: France
facility: LHopital prive du Confluent Nantes
city: Neuilly Sur Seine
country: France
facility: Clinique Hartmann
city: Paris
country: France
facility: Hôpital St-Louis
city: Paris
country: France
facility: Hopital La Pitie Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Saint-Grégoire
country: France
facility: CHP Saint-Grégoire
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de cancerologie de Lorraine
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Essen
country: Germany
facility: University Hospital Essen
city: Georgsmarienhütte
country: Germany
facility: Franziskus Hospital
city: Giessen
country: Germany
facility: HNO-Klinik des Universitats-Klinikums Giessen
city: Greifswald
country: Germany
facility: Universitatsmedizin Greifswald - KoR
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Marienkrankenhaus Hamburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN Mainz III. Klinik/Poliklinik
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Pécs
country: Hungary
facility: University of Pecs Department of Oncotherapy
city: Szekszárd
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria S.Orsola-Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS
city: Cesena
country: Italy
facility: IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori
city: Cuneo
country: Italy
facility: A.O. S. Croce e Carle
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi - Firenze
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo Polo Universitario
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: INT IRCCS Fondazione G.Pascale
city: Novara
country: Italy
facility: A.O.U. "Maggiore della Carita"- S.C.D.U Oncologiac
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" U.O.C. Oncologia Medica
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Pavia
country: Italy
facility: IRCCS Maugeri Pavia
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio e Ruggi D'Aragona, Università degli Studi di Salerno
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
city: Sondrio
country: Italy
facility: ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio
city: Tricase
country: Italy
facility: AO Card. G. Panico
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Udine
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Akashi-shi
country: Japan
facility: Hyogo Cancer Center
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
city: Fukuoka shi
country: Japan
facility: Kyushu University Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Koto-Ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
city: Nagoya
country: Japan
facility: Aichi Cancer Center
city: Osaka Sayama-shi
country: Japan
facility: Kindai University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai
country: Japan
facility: National University Corporation Tohoku University, Tohoku University Hospital
city: Shinagawa-Ku
country: Japan
facility: Showa University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
city: A Coruña
country: Spain
facility: Fundacion Oncologico de Galicia Jos Antonio Quiroga y Pieyro
city: Badalona
country: Spain
facility: Institut Catala d Oncologia Badalona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Vall dHebron Institute of Oncology (VHIO)
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaen
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maran
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro- Majadahonda
city: Málaga
country: Spain
facility: Hospital Regional de Malaga
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Hospital Universitario Santiago de Compostela
city: Sevilla
country: Spain
facility: Valme Hospital Medical Oncology Department
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia - INCLIVA
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital-KaohSiung
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center Liouying
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital-LinKou
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Center
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust - Sutton
Study officials:
affiliation: Adlai Nortye USA Inc.
name: Senior Director, Global Operations
role: STUDY_DIRECTOR
References: