Trial Title:
A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.
NCT ID:
NCT05967689
Condition:
Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
NSCLC
Carcinoma
Non-Small Cell Lung
Lung disease
locally advanced/ metastatic
ex20ins mutation
Insertion Mutations
EGFR uncommon/ single mutation Phase 2, Phase 2b, Phase II Exon 20
TAS6417/ CLN-081
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
4 Cohorts based on eligibility criteria
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAS6417
Description:
Oral tablets/capsules
Arm group label:
Cohort A ("prior ex20ins treatment")
Arm group label:
Cohort B ("1st line treatment")
Arm group label:
Cohort C ("active brain mets")
Arm group label:
Cohort D ("other uncommon EGFRmt").
Other name:
CLN-081
Other name:
zipalertinib
Summary:
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in
patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and
other mutations.
Detailed description:
This study will evaluate the safety and efficacy of zipalertinib in patients with locally
advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or
compound EGFRmt.
Patients will be enrolled into 1 of the 4 following cohorts:
- Cohort A ("prior ex20ins treatment") will include patients harboring EGFR ex20ins
mutations who have progressed on or after initial treatment with standard
platinum-based chemotherapy and prior treatment with an ex20 agent for their
advanced disease (administered together or separately).
- Cohort B ("1st line") will include patients harboring EGFR ex20ins mutations who
have not received prior treatment for advanced disease.
- Cohort C ("active brain mets") will include patients harboring EGFR ex20ins or other
uncommon single and compound mutations and active brain metastases. Patients may or
may not have had prior treatment for advanced disease.
- Cohort D ("other uncommon EGFRmt") will include patients harboring other, non
ex20ins uncommon single or compound EGFRmt who have progressed on or after treatment
with standard systemic anticancer therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent
2. ≥18 years of age (or meets the country's regulatory definition of legal adult age,
whichever is greater
3. Pathologically confirmed, locally advanced or metastatic NSCLC meeting all the
following criteria:
Cohort A patients:
- Documented EGFR ex20ins mutation status, as determined by local testing
performed at a CLIA certified (US) or locally certified laboratory (outside the
US).
- Progressed on or after systemic therapy with an agent targeting ex20ins, either
alone or in combination with standard platinum-based chemotherapy for the
treatment of advanced disease. Patients who discontinued previous treatment due
to unacceptable toxicity are eligible.
- Patients with brain metastasis must be neurologically stable. Patients must
have received CNS-directed therapy and have no evidence of progression for at
least 4 weeks after CNS-directed treatment, as ascertained by clinical
examination and brain imaging (MRI or CT scan) during the screening period, and
they must be on a stable or decreasing dose of corticosteroids and/or
anti-convulsant medications for at least 2 weeks prior to the first dose of
study treatment. Patients with history of uncontrolled seizures or
leptomeningeal disease are not eligible.
Cohort B patients:
- Documented EGFR ex20ins mutation status, as determined by local testing
performed at a CLIA certified (US) or locally certified laboratory (outside the
US).
- Not received prior systemic therapy for locally advanced or metastatic disease.
Prior adjuvant/neoadjuvant treatment for early-stage disease must have been
completed >6 months prior to the first dose of study treatment.
- Patients with brain metastasis must be neurologically stable. Patients must
have received CNS-directed therapy and have no evidence of progression for at
least 4 weeks after CNS-directed treatment, as ascertained by clinical
examination and brain imaging (MRI or CT scan) during the screening period, and
they must be on a stable or decreasing dose of corticosteroids and/or
anti-convulsant medications for at least 2 weeks prior to the first dose of
study treatment. Patients with history of uncontrolled seizures or
leptomeningeal disease are not eligible.
Cohort C patients:
- Documented EGFR ex20ins mutation status, as determined by local testing
performed at a CLIA certified (US) or locally certified laboratory (outside the
US).
- Presence of brain metastasis(es), which may be measurable or nonmeasurable by
RANO-BM criteria, characterized as one of the following:
- Newly diagnosed and/or progressive brain metastasis (es) not subjected to
CNS-directed therapy, OR
- Leptomeningeal disease (LMD) confirmed by a positive cerebrospinal fluid
cytology, or unequivocal radiographic and/or clinical determination.
Cohort D patients:
- Documented other non-ex20ins uncommon single or compound EGFRmt status, as
determined by local testing performed at a CLIA certified (US) or locally
certified laboratory (outside the US). A list of eligible mutations will be
provided in a separate manual.
- Patients with brain metastasis must be neurologically stable. Patients must
have received CNS-directed therapy and have no evidence of progression for at
least 4 weeks after CNS-directed treatment, as ascertained by clinical
examination and brain imaging (MRI or CT scan) during the screening period, and
they must be on a stable or decreasing dose of corticosteroids and/or
anti-convulsant medications for at least 2 weeks prior to the first dose of
study treatment. Patients with history of uncontrolled seizures or
leptomeningeal disease are not eligible.
4. Measurable disease per RECIST 1.1.
5. Archival tumor tissue available for submission, with minimum quantity sufficient to
evaluate EGFRmt status and, where possible, other biomarkers (details provided in a
laboratory manual). Patients with insufficient tissue may be eligible following
discussion with the sponsor.
6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 17. Adequate
organ function, as defined by the hematologic, renal and hepatic laboratory values
4. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
prior to administration of the first dose of study treatment. Female patients are
not considered to be of childbearing potential if they are post-menopausal (no
menses for 12 months without an alternative medical cause) or permanently sterile
(hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
5. Both males and females of reproductive potential must agree to use effective birth
control during the study prior to the first dose of study drug and for 6 months
after the last dose of study treatment.
Exclusion Criteria:
1. Patient is currently receiving an investigational drug in a clinical trial or
participating in any other type of medical research judged to be scientifically or
medically incompatible with this study.
2. Has received any of the following within the specific time frame specified:
1. Patient has received Zipalertinib (TAS6417/CLN081) at any time
2. Thoracic radiotherapy ≤28 days or palliative radiation ≤14 days prior to the
first dose of study treatment
3. Anticancer immunotherapy ≤28 days prior to the first dose of study treatment
4. Major surgery (excluding placement of vascular access) ≤28 days prior to the
first dose of study treatment.
3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment, except
for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable
Grade 2 toxicities may be allowed to enroll after agreement between the investigator
and Sponsor.
4. Past medical history of interstitial lung disease, treatment-related pneumonitis
(any grade), or evidence of clinically active interstitial lung disease.
5. Impaired cardiac function or clinically significant cardiac disease including any of
the following:
1. History of congestive heart failure (CHF) Class III/IV according to the New
York Heart Association (NYHA) Functional Classification (Appendix A)
2. Serious cardiac arrhythmias requiring treatment.
3. Resting corrected QT interval (QTc) >470 msec using Fridericia's formula
(QTcF).
6. Is unable to swallow tablets/capsules or has any disease or condition that may
significantly affect gastrointestinal absorption of zipalertinib (eg, inflammatory
bowel disease, malabsorption syndrome, or prior gastric/bowel resection).
7. History of another primary malignancy ≤2 years prior to the date of first dose of
study treatment unless at least one of the following criteria are met:
1. Adequately treated basal or squamous cell carcinoma of the skin
2. Cancer of the breast or cervix in situ
3. Patients with previously treated malignancy if all treatment for that
malignancy was completed at least 2 years prior to first dose and no evidence
of disease
4. Patients with concurrent malignancy clinically stable and not requiring
tumor-directed treatment
8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
that is not controlled with treatment.
9. History of COVID-19 infection within 4 weeks prior to enrolment and/or has
persistent clinically significant pulmonary symptoms related to prior COVID-19
infection.
10. Active bleeding disorders.
11. Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in
structure or class.
12. Is pregnant or lactating.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope - Duarte (Main Campus)
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope - Huntington Beach
Address:
City:
Huntington Beach
Zip:
92648
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope Orange County Lennar Foundation Cancer Center
Address:
City:
Irvine
Zip:
92618
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI - Florida Cancer Specialists - East Region Research Office
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Henderson
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
Address:
City:
Henderson
Zip:
89074
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Northwest
Address:
City:
Las Vegas
Zip:
89128
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
Address:
City:
Las Vegas
Zip:
89144
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Southwest
Address:
City:
Las Vegas
Zip:
89148
Country:
United States
Status:
Recruiting
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - New York
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Facility:
Name:
Gabrail Cancer and Research Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI - Mark H. Zangmeister Cancer Center
Address:
City:
Columbus
Zip:
43219
Country:
United States
Status:
Recruiting
Facility:
Name:
The Toledo Clinic Cancer Center
Address:
City:
Toledo
Zip:
43623
Country:
United States
Status:
Recruiting
Facility:
Name:
USOR - Alliance Cancer Specialists - Horsham (Abington Hematology Oncology Associates)
Address:
City:
Horsham
Zip:
19044
Country:
United States
Status:
Withdrawn
Facility:
Name:
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists - Arlington Office
Address:
City:
Arlington
Zip:
22205
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists - Fairfax Office
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists - Gainesville Office
Address:
City:
Gainesville
Zip:
20155
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Specialists - Reston
Address:
City:
Reston
Zip:
20190
Country:
United States
Status:
Recruiting
Facility:
Name:
Froedtert and Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Facility:
Name:
Bankstown-Lidcombe Hospital
Address:
City:
Bankstown
Zip:
2200
Country:
Australia
Status:
Recruiting
Facility:
Name:
GenesisCare - North Shore
Address:
City:
Saint Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Joondalup Health Campus
Address:
City:
Joondalup
Zip:
6027
Country:
Australia
Status:
Recruiting
Facility:
Name:
McGill University Health Centre
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
William Osler Health System - Brampton Civic Hospital
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Les Hôpitaux Universitaires de Strasbourg
Address:
City:
Strasbourg cedex
Zip:
67091
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Côte De Nacre
Address:
City:
Caen cedex 9
Zip:
14033
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris cedex 05
Zip:
75248
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire Limoges
Address:
City:
Limoges cedex
Zip:
87042
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Address:
City:
Saint-Herblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Haut-Lévêque
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Recruiting
Facility:
Name:
Hôpital Nord de Marseille
Address:
City:
Marseille
Zip:
13015
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Withdrawn
Facility:
Name:
Hôpital Ambroise-Paré
Address:
City:
Boulogne-Billancourt
Zip:
92100
Country:
France
Status:
Recruiting
Facility:
Name:
Klinikum Esslingen
Address:
City:
Esslingen
Zip:
73730
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Asklepios Klinik Altona
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Klinikum Kassel
Address:
City:
Kassel
Zip:
34125
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Gießen und Marburg - Gießen
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universität zu Köln
Address:
City:
Köln
Zip:
50937
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Universitatsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01301
Country:
Germany
Status:
Recruiting
Facility:
Name:
LMU Klinikum - Campus Innenstadt
Address:
City:
München
Zip:
80337
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Universitätsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Queen Mary Hospital - Hong Kong
Address:
City:
Pok Fu Lam
Country:
Hong Kong
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria Careggi
Address:
City:
Firenze
Zip:
50134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Degli Infermi di Faenza
Address:
City:
Faenza
Zip:
48018
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Ospedale IUmberto Ii di Lugo
Address:
City:
Lugo
Zip:
48022
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
Address:
City:
Catania
Zip:
95125
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Socio-Sanitaria Territoriale di Cremona
Address:
City:
Cremona
Zip:
26100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Policlinico San Martino
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria di Modena
Address:
City:
Modena
Zip:
41124
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero-Universitaria di Parma
Address:
City:
Parma
Zip:
43126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Unità Sanitaria Locale - Piacenza
Address:
City:
Piacenza
Zip:
29121
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Unità Sanitaria Locale della Romagna
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kyushu Cancer Center
Address:
City:
Fukuoka-shi
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Sendai
Zip:
980-0873
Country:
Japan
Status:
Recruiting
Facility:
Name:
Kindai University Hospital
Address:
City:
Ōsaka-sayama-Shi
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Niigata Cancer Center Hospital
Address:
City:
Niigata
Zip:
951-8566
Country:
Japan
Status:
Recruiting
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center - Korea
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Status:
Withdrawn
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Catholic University of Korea Saint Vincent's Hospital
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon-si
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju
Zip:
52727
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Inha University Hospital
Address:
City:
Incheon
Zip:
22332
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Withdrawn
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea - Seoul St. Mary's Hospital
Address:
City:
Soeul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Address:
City:
L'Hospitalet De Llobregat
Zip:
08908
Country:
Spain
Status:
Withdrawn
Facility:
Name:
Complejo Hospitalario Universitario A Coruña
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Regional Universitario de Málaga - Hospital General
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Clínica Mi Tres Torres
Address:
City:
Barcelona
Zip:
08017
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Quirónsalud Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08025
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario de Jaén
Address:
City:
Jaén
Zip:
23007
Country:
Spain
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center Madrid
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?
Address:
City:
Cankaya
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
Address:
City:
Etlik
Zip:
06010
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dicle Üniversitesi Tip Fakültesi
Address:
City:
Sur
Zip:
21280
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Istinye Üniversite Hastanesi Liv Hospital Bahcesehir
Address:
City:
Esenyurt
Zip:
34517
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Medical Park Seyhan Hastanesi
Address:
City:
Adana
Zip:
01040
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
Address:
City:
Adana
Zip:
01370
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Hacettepe Üniversitesi Kanser Enstitüsü
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Memorial Ankara Hastanesi
Address:
City:
Ankara
Zip:
6520
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Trakya Üniversitesi Saglik Arastirma ve Uygulama Merkezi
Address:
City:
Edirne
Zip:
22030
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bagcilar Medipol Mega Universite Hastanesi
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Recruiting
Facility:
Name:
T.C. Saglik Bakanligi - Istanbul Il Saglik Mudurlugu - Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Address:
City:
Istanbul
Zip:
34722
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Royal Free London NHS Foundation Trust
Address:
City:
London
Zip:
NW3 2QG
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Recruiting
Start date:
July 27, 2023
Completion date:
October 20, 2025
Lead sponsor:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Source:
Taiho Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05967689
