Trial Title:
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
NCT ID:
NCT05973773
Condition:
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Exon 20 insertion mutation
NSCLC
phase 3
Lung disease
Carcinoma, Non-Small-Cell Lung
CLN-081
TAS6417
EGFR
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TAS6417
Description:
oral tablets
Arm group label:
Part A (Safety Lead in)
Arm group label:
Part B
Other name:
Zipalertinib
Other name:
CLN-081
Summary:
The purpose of this study is to evaluate the safety and efficacy of zipalertinib in
combination with standard first-line platinum-based chemotherapy compared to chemotherapy
alone, in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations.
Detailed description:
This study will evaluate the efficacy and safety of zipalertinib in combination with
standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or
cisplatin) in patients with previously untreated, locally advanced or metastatic
nonsquamous NSCLC harboring EGFR ex20ins mutations.
The study will be conducted in two parts:
- Part A: Safety lead-in to determine the recommended dose of zipalertinib in
combination with standard chemotherapy pemetrexed and a platinum agent (either
carboplatin or cisplatin) to be studied in Part B of the study.
- Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess
the efficacy and safety of zipalertinib in combination with standard chemotherapy
with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to
standard chemotherapy alone. Patients randomized to the chemotherapy-only treatment
arm in Part B may receive treatment with zipalertinib as monotherapy after
BICR-assessed progressive disease (PD) is documented (optional "crossover arm").
An independent data monitoring committee (IDMC) will be established to monitor interim
safety Data.
A treatment cycle is defined as 21 days for both parts of the study.
Part A: Safety Lead-In The primary objective of Part A is to determine the recommended
dose of zipalertinib administered in combination with pemetrexed and a platinum agent
(either carboplatin or cisplatin) to be studied in the Phase 3 portion of this study.
Approximately 6-12 patients will receive zipalertinib administered at an initial dose of
zipalertinib PO BID (Dose Level 1) in combination with pemetrexed and carboplatin or
cisplatin on a 21-day cycle. Patients may continue to receive study treatment until
documentation of progressive disease (PD) or until other withdrawal criteria are met,
whichever comes first. Patients will be enrolled using a rolling-6 design,35 and the
determination of the dose of zipalertinib to be used in Part B of the study will be
informed by the incidence of dose-limiting toxicities (DLTs) observed during Cycle 1.
Part B: Phase 3 Enrollment into the Phase 3 portion of the study will begin following
completion of Part A.
Approximately 260 patients will be randomized on a 1:1 basis to receive pemetrexed and a
platinum agent (either carboplatin or cisplatin) with or without zipalertinib on a 21-day
cycle.
Carboplatin or cisplatin will be administered for 4 cycles. Patients may continue to
receive zipalertinib (experimental study arm) and pemetrexed (both study arms) until
documentation of PD or until other withdrawal criteria are met, whichever comes first.
Criteria for eligibility:
Criteria:
Inclusion-
1. Provide written informed consent.
2. ≥18 years of age (or meets the country's regulatory definition for legal adult age,
whichever is greater).
3. Pathologically confirmed, locally advanced or metastatic nonsquamous NSCLC
4. Has not received any prior systemic treatment for their locally advanced or
metastatic nonsquamous NSCLC. Prior adjuvant/neoadjuvant treatment received >6
months prior to first dose of study treatment is allowed for early-stage
NSCLC. Prior monotherapy with an approved EGFR TKI (ie, gefitinib, erlotinib,
afatinib, dacomitinib, or osimertinib) as nonstandard first-line therapy for the
treatment of locally advanced or metastatic disease is allowed if all of the
following criteria are met:
1. Treatment duration did not exceed 8 weeks;
2. Lack of disease response was documented (radiographically) by an increase in
tumor burden (a copy of the computerized tomography [CT] report showing
increase in tumor burden from baseline should be submitted);
3. Associated toxicities have resolved to baseline; and
4. The EGFR TKI was discontinued at least 2 weeks or 4 half-lives prior to
randomization, whichever is longer.
Prior therapy with EGFR TKI agents targeting exon20ins mutations including
amivantamab, mobocertinib, sunvozertinib, furmonertinib, and poziotinib is not
allowed.
5. Documented EGFR mutation status, as determined by local testing performed at a CLIA
certified (US) or accredited (outside of the US) local laboratory, defined as
follows:
1. Part A: EGFR ex20ins or other uncommon single or compound EGFR mutation
2. Part B: EGFR ex20ins mutation
6. Archival tumor tissue available for submission, with minimum quantity sufficient to
evaluate EGFR mutation status and, where possible, other biomarkers. Patients with
insufficient tissue (details provided in laboratory manual) may be eligible
following discussion with the sponsor; a fresh biopsy will not be required.
7. Patients with brain metastasis(es) who have previously received definitive local
treatment and have stable central nervous system (CNS) disease (defined as being
neurologically stable and off corticosteroid for at least 2 weeks prior to
enrollment) are eligible. If brain metastases are diagnosed on screening imaging,
the patient may be rescreened for eligibility after definitive treatment.
b. Asymptomatic brain metastases ≤2 cm in size can be eligible for inclusion if, in
the opinion of the Investigator, immediate definitive treatment is not indicated.
8. At least one measurable lesion as determined per RECIST 1.1 for patients enrolling
to Part B. Patients enrolling to Part A may be enrolled without measurable disease.
9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
10. Adequate organ function, as defined by the laboratory value
11. Have a life expectancy of at least 3 months as assessed by the investigator.
12. 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 postmenopausal (no menses
for 12 months without an alternative medical cause) or permanently sterile
(hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
13. Both males and females of reproductive potential must agree to use effective birth
control during the study prior to the first dose and for 6 months after the last
dose of study treatment or longer, based on local requirements.
Exclusion -
1. Is currently receiving an investigational drug in a clinical trial or participating
in any other type of medical research judged not to be scientifically or medically
compatible with this study.
2. Prior treatment with any of the following within the specific time frame specified:
1. Zipalertinib (TAS6417/CLN-081) at any time.
2. Thoracic radiotherapy ≤28 days, palliative radiation of nonthoracic disease ≤14
days, or palliative radiation of a single lesion ≤7 days prior to first dose of
study treatment.
3. Major surgery (excluding placement of vascular access) ≤28 days prior to first
dose of study treatment.
4. All prescribed medication, over-the-counter medication, vitamin preparations
and other food supplements, or herbal medications that are strong or moderate
CYP3A4 inducers or inhibitors within 7 days prior to first dose.
3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment in the
neoadjuvant or adjuvant setting, 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 any 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 .
2. Serious cardiac arrhythmias requiring treatment.
3. Resting corrected QT interval (QTc) >470 msec calculated using Fridericia's
formula (QTcF).
6. Unable to swallow tablets or has any disease or condition that may significantly
affect gastrointestinal (GI) absorption of zipalertinib (such as inflammatory bowel
disease, malabsorption syndrome, or prior GI 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. Previously treated malignancy, if all treatment for that malignancy was
completed at least 2 years prior to first dose of study treatment, and no
current evidence of disease
4. Concurrent malignancy determined to be clinically stable and not requiring
tumor directed treatment
8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
that is unstable or not controlled with treatment.
9. History of COVID-19 infection within 4 weeks prior to enrolment and/or have
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. To platinum-containing drugs (ie, cisplatin, carboplatin),
pemetrexed, or any known excipients of these drugs. b. Contraindications toning
drugs (ie, cisplatin, carboplatin) or pemetrexed according to the respective local
labels.
12. History of leptomeningeal disease and spinal cord compression.
13. Is unable or unwilling to take dexamethasone, folic acid, and/or vitamin B12
supplementation during treatment with pemetrexed.
14. Is pregnant or lactating or planning to become pregnant
15. The patient is, in the investigator's opinion, unable or unwilling to comply with
the trial procedures.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Henderson
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson
Address:
City:
Henderson
Zip:
89052
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
Address:
City:
Henderson
Zip:
89074
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
Address:
City:
Las Vegas
Zip:
89144
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Southwest
Address:
City:
Las Vegas
Zip:
89148
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Address:
City:
Las Vegas
Zip:
89169
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Comprehensive Cancer Centers of Nevada - Northwest
Address:
City:
Las Vegas
Zip:
89218
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ramalingam Ratnasabapathy
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer and Research Center
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Nashat Gabrail
Email:
Principal Investigator
Facility:
Name:
The Toledo Clinic Cancer Center
Address:
City:
Toledo
Zip:
43623
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:
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Algemeen Ziekenhuis Maria Middelares
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Algemeen Ziekenhuis Delta - Campus Rumbeke
Address:
City:
Rosières
Zip:
8800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
William Osler Health System - Brampton Civic Hospital
Address:
City:
Brampton
Zip:
L6R 3J7
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Les Hôpitaux Universitaires de Strasbourg
Address:
City:
Strasbourg cedex
Zip:
67091
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Côte De Nacre
Address:
City:
Caen cedex 9
Zip:
14033
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris cedex
Zip:
75248
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Universitaire Limoges
Address:
City:
Limoges
Zip:
87042
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Haut-Lévêque
Address:
City:
Pessac
Zip:
33604
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Hospitalier Le Mans
Address:
City:
Le Mans cedex 9
Zip:
72037
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Hôpital Ambroise-Paré
Address:
City:
Boulogne-Billancourt
Zip:
92100
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Asklepios Klinik Altona
Address:
City:
Hamburg
Zip:
22763
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitätsklinikum Gießen und Marburg - Gießen
Address:
City:
Gießen
Zip:
35392
Country:
Germany
Status:
Recruiting
Facility:
Name:
LMU Klinikum - Campus Innenstadt
Address:
City:
München
Zip:
80337
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitätsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
BioClinic Thessaloniki
Address:
City:
Thessaloniki
Zip:
54622
Country:
Greece
Status:
Recruiting
Facility:
Name:
Emek Medical Center
Address:
City:
Afula
Zip:
18101
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Hadassah University Hospital Ein Kerem
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Assuta Hospital - Ramat HaHayal
Address:
City:
Tel aviv
Zip:
69710
Country:
Israel
Status:
Not yet recruiting
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliero - Universitaria di Modena
Address:
City:
Modena
Zip:
41224
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Unità Sanitaria Locale della Romagna
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata Verona
Address:
City:
Verona
Zip:
37126
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya
Zip:
464-8681
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Yutaka Fujiwara
Email:
Principal Investigator
Facility:
Name:
Hirosaki University Hospital
Address:
City:
Hirosaki-Shi
Zip:
036-8563
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Hisashi Tanaka
Email:
Principal Investigator
Facility:
Name:
Kyushu Cancer Center
Address:
City:
Fukuoka-shi
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Masafumi Yamaguchi
Email:
Principal Investigator
Facility:
Name:
Kitasato University Hospital
Address:
City:
Sagamihara
Zip:
252-0375
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Katsuhiko Naoki
Email:
Principal Investigator
Facility:
Name:
Kanagawa Cardiovascular and Respiratory Center
Address:
City:
Yokohama
Zip:
236-0051
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Satoshi Ikeda
Email:
Principal Investigator
Facility:
Name:
Saiseikai Kumamoto Hospital
Address:
City:
Kumamoto-Shi
Zip:
861-4163
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Yoshihiko Sakata
Email:
Principal Investigator
Facility:
Name:
Sendai Kousei Hospital
Address:
City:
Sendai
Zip:
980-0873
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Shunichi Sugawara
Email:
Principal Investigator
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayamashi
Zip:
700-8558
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Kadoaki Ohashi
Email:
Principal Investigator
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Hirakata
Zip:
573-1191
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Takayasu Kurata
Email:
Principal Investigator
Facility:
Name:
National Hospital Organization Kinki-Chuo Chest Medical Center
Address:
City:
Sakai-Shi
Zip:
591-8555
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Akihiro Tamiya
Email:
Principal Investigator
Facility:
Name:
Cancer Institute Hospital of JFCR
Address:
City:
Koto
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Ryo Ariyasu
Email:
Principal Investigator
Facility:
Name:
Keio University Hospital
Address:
City:
Shinjuku-Ku
Zip:
160-8582
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Kanazawa University Hospital
Address:
City:
Kanazawa
Zip:
920-8641
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Hisashi Tanaka
Email:
Principal Investigator
Facility:
Name:
Osaka City General Hospital
Address:
City:
Osaka
Zip:
534-0021
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Haruko Daga
Email:
Principal Investigator
Facility:
Name:
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Status:
Recruiting
Investigator:
Last name:
Takako Inoue
Email:
Principal Investigator
Facility:
Name:
Catholic University of Korea Saint Vincent's Hospital
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon-si
Zip:
16499
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Jinju
Zip:
52727
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Inha University Hospital
Address:
City:
Incheon
Zip:
22332
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Radboud Universitair Medisch Centrum
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Vrije Universiteit Medisch Centrum
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Investigator:
Last name:
Sayed Hashemi
Email:
Principal Investigator
Facility:
Name:
St. Luke's Medical Center - Quezon City
Address:
City:
Quezon City
Zip:
1112
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Address:
City:
Lublin
Zip:
20-954
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Instytut MSF
Address:
City:
Łódź
Zip:
90-302
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów
Address:
City:
Pozna?
Zip:
60-569
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Tan Tock Seng Hospital
Address:
City:
Singapore
Zip:
30433
Country:
Singapore
Status:
Not yet recruiting
Facility:
Name:
Complejo Hospitalario Universitario A Coruña
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Clínica Mi Tres Torres
Address:
City:
Barcelona
Zip:
08017
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Santiago Viteri Ramírez
Email:
Principal Investigator
Facility:
Name:
Hospital Quirónsalud Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Florencia Garcia Casabal
Email:
Principal Investigator
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
Investigator:
Last name:
Ana Laura Ortega-Granados
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center Madrid
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario Fundación Jiménez Díaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Francisco Javier de Castro Carpeno
Email:
Principal Investigator
Facility:
Name:
Hospital Regional Universitario de Málaga - Hospital General
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Torbay and South Devon NHS Foundation Trust
Address:
City:
Torquay
Zip:
TQ2 7AA
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastanesi
Address:
City:
Adana
Zip:
01060
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Medical Park Seyhan Hastanesi
Address:
City:
Adana
Zip:
01120
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Memorial Ankara Hastanesi
Address:
City:
Ankara
Zip:
6520
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Trakya Üniversitesi Sa?l?k Ara?t?rma ve Uygulama Merkezi
Address:
City:
Edirne
Zip:
22130
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve Arastirma Hastanesi
Address:
City:
Etlik
Zip:
06010
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Bagcilar Medipol Mega Universite Hastanesi
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Not yet 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:
Not yet recruiting
Facility:
Name:
T.C. Saglik Bakanligi Ankara Bilkent Sehi?r Hastanesi?
Address:
City:
Çankaya
Zip:
06800
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Royal Free London NHS Foundation Trust
Address:
City:
London
Zip:
NW3 2QG
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
June 30, 2023
Completion date:
August 24, 2026
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/NCT05973773
