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JOURNAL ONKOLOGIE – STUDIE
LIBRETTO-432

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

Rekrutierend

NCT-Nummer:
NCT04819100

Studienbeginn:
Dezember 2021

Letztes Update:
26.03.2024

Wirkstoff:
Selpercatinib, Placebo

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Loxo Oncology, Inc.

Collaborator:
Eli Lilly and Company

Studienleiter

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 206)

Thoraxklinik-Heidelberg gGmbH
69126 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Lungenkrebszentrum Klinik Löwenstein
Geißhölzle 62
74245 Löwenstein
DeutschlandRekrutierend» Google-Maps
Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-Maps
Klinikum der Ludwig-Maximilians-Universitaet Muenchen
80336 München
(Bayern)
GermanyRekrutierend» Google-Maps
Lungenfachklinik Immenhausen
34376 Immenhausen
(Hessen)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum Franziskus-Hospital Harderberg
Alte Rothenfelder Straße 23
49124 Georgsmarienhütte
DeutschlandRekrutierend» Google-Maps
KRH, Klinikum Siloah
30459 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Münster - Albert Schweitzer Campus
48149 Münster
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
LungenClinic Grosshansdorf
22927 Grosshansdorf
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
UCLA Hematology/Oncology - Santa Monica
90404 Los Angeles
United StatesRekrutierend» Google-Maps
Stockton Hematology Oncology Group
95204 Stockton
United StatesRekrutierend» Google-Maps
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
90502 Torrance
United StatesRekrutierend» Google-Maps
GenesisCare - Boca Raton
33431 Boca Raton
United StatesAbgeschlossen» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Mayo Clinic in Rochester, Minnesota
55905 Rochester
United StatesRekrutierend» Google-Maps
USO - New York Oncology Hematology, P.C.
12206 Albany
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute SCRI
37203 Nashville
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute SCRI
37203 Nashville
United StatesRekrutierend» Google-Maps
Tennessee Oncology Nashville
37203 Nashville
United StatesRekrutierend» Google-Maps
Sunshine Coast University Hospital
4575 Birtinya
AustraliaRekrutierend» Google-Maps
Ballarat Health Services
3350 Ballarat Central
AustraliaRekrutierend» Google-Maps
Landeskrankenhaus Feldkirch
6800 Feldkirch
AustriaRekrutierend» Google-Maps
Cliniques universitaires Saint-Luc
1200 Brussels
BelgiumRekrutierend» Google-Maps
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
5530 Yvoir
BelgiumRekrutierend» Google-Maps
Nucleo de Oncologia da Bahia
40170-070 Salvador
BrazilRekrutierend» Google-Maps
Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul
70200-730 Brasilia
BrazilNoch nicht rekrutierend» Google-Maps
Centro Avançado de Tratamento Oncológico- CENANTRON
30130090 Belo Horizonte
BrazilRekrutierend» Google-Maps
Centro Oncológico do Triângulo
38408-150 Uberlândia
BrazilRekrutierend» Google-Maps
Hospital de Câncer de Recife
50040-000 Recife
BrazilRekrutierend» Google-Maps
Hospital São Lucas da PUCRS
90610-000 Porto Alegre
BrazilRekrutierend» Google-Maps
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
05652-900 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Instituto de Educação, Pesquisa e Gestão em Saúde
22775001 Rio de Janeiro
BrazilRekrutierend» Google-Maps
Centro Paulista de Oncologia Clínica
01452-000 São Paulo
BrazilRekrutierend» Google-Maps
Núcleo de Pesquisa Clínica da Rede São Camilo
04014-002 São Paulo
BrazilRekrutierend» Google-Maps
Princess Margaret Cancer Centre
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Beijing Cancer hospital
100142 Haidian District
ChinaRekrutierend» Google-Maps
Southern Medical University Nanfang Hospital
510515 Guangzhou
ChinaRekrutierend» Google-Maps
Guangdong Provincial People's Hospital
Guangzhou
ChinaRekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaRekrutierend» Google-Maps
Xiangya Hospital, Central South University
410008 Changsha
ChinaRekrutierend» Google-Maps
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
710038 Xi'an
ChinaRekrutierend» Google-Maps
Zhongshan Hospital, Fudan University
200032 Shanghai
ChinaRekrutierend» Google-Maps
the Third People's Hospital of Chengdu
610031 Chengdu
ChinaRekrutierend» Google-Maps
West China Hospital of Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
First Affiliated Hosp of College of Med, Zhejiang University
310003 Hangzhou
ChinaRekrutierend» Google-Maps
Nemocnice AGEL Ostrava - Vitkovice a.s
703 84 Ostrava
CzechiaRekrutierend» Google-Maps
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
13385 Marseille
FranceRekrutierend» Google-Maps
Centre Chirurgical Marie Lannelongue
92350 Le Plessis-Robinson
FranceRekrutierend» Google-Maps
Hospices Civils de Lyon - Hopital Louis Pradel
69677 Lyon
FranceRekrutierend» Google-Maps
Hopitaux Universitaires Paris Centre-Hopital Cochin
75014 Paris
FranceRekrutierend» Google-Maps
Agios Savvas Regional Cancer Hospital
115 22 Athens
GreeceRekrutierend» Google-Maps
Errikos Dunant Hospital Center
115 26 Athens
GreeceRekrutierend» Google-Maps
Sotiria Thoracic Diseases Hospital of Athens
11527 Athens
GreeceRekrutierend» Google-Maps
University General Hospital of Heraklion
711 10 Heraklion
GreeceRekrutierend» Google-Maps
G. Papanikolaou General Hospital
570 10 Thessaloniki
GreeceRekrutierend» Google-Maps
Hong Kong United Oncology Centre
000000 Hong Kong
Hong KongRekrutierend» Google-Maps
Princess Margaret Hospital
999077 Lai Chi Kok
Hong KongRekrutierend» Google-Maps
Rajiv Gandhi Cancer Institute And Research Centre
110085 New Delhi
IndiaRekrutierend» Google-Maps
Regional Cancer Centre - Thiruvananthapuram
695011 Thiruvananthapuram
IndiaRekrutierend» Google-Maps
Rashtrasant Tukdoji Regional Cancer Hospital
440027 Nagpur
IndiaRekrutierend» Google-Maps
ASST Grande Ospedale Metropolitano Niguarda
20162 Milan
ItalyRekrutierend» Google-Maps
Instituto Tumori Giovanni Paolo II
70124 Bari
ItalyRekrutierend» Google-Maps
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
10043 Orbassano
ItalyRekrutierend» Google-Maps
Istituto Oncologico Veneto IRCCS
35128 Padova
ItalyRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
Niigata Cancer Center Hospital
951-8566 Niigata
JapanRekrutierend» Google-Maps
Hiroshima University Hospital
734-8551 Hiroshima
JapanRekrutierend» Google-Maps
Osaka Medical Center for Cancer and Cardiovascular Diseases
541-8567 Osaka
JapanRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun
Korea, Republic ofRekrutierend» Google-Maps
National Cancer Center
10408 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
3080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System
3722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
6351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
8308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
41404 Deagu
Korea, Republic ofRekrutierend» Google-Maps
Actualidad Basada en la Investigación del Cáncer
44680 Guadalajara
MexicoAbgeschlossen» Google-Maps
Avix Investigación Clinica, S.C.
64710 Monterrey
MexicoAbgeschlossen» Google-Maps
Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"
66460 Monterrey
MexicoAbgeschlossen» Google-Maps
Ziekenhuis St. Jansdal
3844 DG Harderwijk
NetherlandsRekrutierend» Google-Maps
Oslo Universitetssykehus Ullevål
0450 Oslo
NorwayRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
02-781 Warszawa
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne
80-952 Gdańsk
PolandRekrutierend» Google-Maps
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
60-569 Poznan
PolandRekrutierend» Google-Maps
Pan American Center for Oncology Trials
00935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Arkhangelsk Clinical Oncological Dispensary
163045 Arkhangelsk
Russian FederationAbgeschlossen» Google-Maps
First Pavlov State Medical University of Saint Petersburg
197022 Saint Petersburg
Russian FederationAbgeschlossen» Google-Maps
Scientific research institution of oncology named after N.N. Petrov
197758 Sankt-Peterburg
Russian FederationAbgeschlossen» Google-Maps
Parkway Cancer Centre - Gleneagles Hospital
258500 Singapore
SingaporeRekrutierend» Google-Maps
CHUS - Hospital Clinico Universitario
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Cordoba
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta del Mar
11009 Cádiz
SpainRekrutierend» Google-Maps
Hospital Universitario Central de Asturias
33011 Oviedo
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia (ICO) - Badalona
08916 Badalona
SpainRekrutierend» Google-Maps
Parc de Salut Mar - Hospital del Mar
8003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
8035 Barcelona
SpainRekrutierend» Google-Maps
Instituto Catalan de Oncologia - Hospital Duran i Reynals
8907 L'Hospitalet Del Llobregat
SpainRekrutierend» Google-Maps
Complejo Asistencial Universitario de León - Hospital de León
24071 León
SpainRekrutierend» Google-Maps
Hospital Universitari Dexeusa
8028 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clínic de Barcelona
8036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramón y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario Virgen de la Arrixaca
30120 El Palmar, Murcia
SpainRekrutierend» Google-Maps
Complexo Hospitalario Universitario de Ourense
32005 Ourense
SpainRekrutierend» Google-Maps
CHUVI- Hospital Alvaro Cunqueiro
36312 Pontevedra
SpainRekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 La Laguna
SpainRekrutierend» Google-Maps
Hospital Universitari Sant Joan de Reus
43204 Reus
SpainRekrutierend» Google-Maps
Hospital General Universitario de Albacete
2006 Albacete
SpainRekrutierend» Google-Maps
Hospital Regional Universitario
29011 Málaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen Macarena
41009 Sevilla
SpainRekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe
46026 València
SpainRekrutierend» Google-Maps
Sahlgrenska Universitetssjukhuset
413 45 Gothenburg
SwedenRekrutierend» Google-Maps
Changhua Christian Hospital
50006 Changhua County
TaiwanRekrutierend» Google-Maps
Chang Gung Memorial Hospital at Kaohsiung
83301 Kaohsiung Niao Sung Dist
TaiwanRekrutierend» Google-Maps
Chung Shan Medical University Hospital
402 Taichung City
TaiwanRekrutierend» Google-Maps
Chi Mei Hospital - Liouying Branch
73657 Tainan City
TaiwanRekrutierend» Google-Maps
National Taiwan University Cancer Center (NTUCC)
106 Taipei City
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
112 Taipei City
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
TaiwanRekrutierend» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation-Linkou Branch
333 Taoyuan
TaiwanRekrutierend» Google-Maps
Baskent University Dr. Turgut Noyan Research and Training Center
1250 Adana
TurkeyRekrutierend» Google-Maps
Izmir Medical Park Hospital
009035575 Izmir, Karsiyaka
TurkeyRekrutierend» Google-Maps
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma
6200 Ankara
TurkeyRekrutierend» Google-Maps
Medipol Mega Universite Hastanesi
34214 Istanbul
TurkeyRekrutierend» Google-Maps
Izmir Katip Celebi Universitesi Ataturk Egitim Ve Arastrma Hastanesi
35620 Izmir
TurkeyRekrutierend» Google-Maps
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma
44280 Malatya
TurkeyRekrutierend» Google-Maps
Sumy regional clinical oncological dispensary
40022 Sumy
UkraineRekrutierend» Google-Maps
Chelsea and Westminster Hospital NHS Foundation Trust
SW10 9NH London
United KingdomRekrutierend» Google-Maps
Royal Brompton Hospital
SW3 6NP London
United KingdomRekrutierend» Google-Maps
University College London Hospital
NW1 2PG London
United KingdomRekrutierend» Google-Maps
City Hospital, Nottingham University Hospitals
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
New Cross Hospital
WV10 0QP Wolverhampton
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is

effective and safe in delaying cancer return in participants with early-stage non-small cell

lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned

to placebo and stop the study drug because their disease comes back or gets worse have the

option to potentially crossover to selpercatinib. Participation could last up to three years.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Must have histologically confirmed Stage IB, II, or IIIA NSCLC.

- Must have an activating RET gene fusion in tumor based on polymerase chain reaction

(PCR), next generation sequencing (NGS), or another molecular test per sponsor's

approval.

- Must have received definitive locoregional therapy with curative intent (surgery or

radiotherapy) for Stage IB, II, or IIIA NSCLC.

-- Must have undergone the available anti-cancer therapy (including chemotherapy or

durvalumab) or not be suitable for it, based on the investigator's discretion.

- Maximum time allowed between definitive therapy completion and randomization must be:

- 10 weeks if no chemotherapy was administered

- 26 weeks if adjuvant chemotherapy was administered

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- Adequate hematologic, hepatic, and renal function.

- Willingness of men and women of reproductive potential to observe conventional and

highly effective birth control for the duration of the study and for at least 2 weeks

after last dose of study drug.

Exclusion Criteria:

- Additional oncogenic drivers in NSCLC, if known.

- Evidence of small cell lung cancer.

- Clinical or radiologic evidence of disease recurrence or progression following

definitive therapy.

- Known or suspected interstitial fibrosis or interstitial lung disease or history of

(noninfectious) pneumonitis that required steroids.

- Clinically significant active cardiovascular disease or history of myocardial

infarction within six months prior to planned start of selpercatinib or prolongation

of the QT interval corrected for heart rate using Fridericia's formula (QTcF) greater

than 470 milliseconds.

- Have known uncontrolled human immunodeficiency virus (HIV)-1/2 infection.

- Have known active hepatitis B or C.

- Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing

intercurrent illness, such as hypertension or diabetes, despite optimal treatment.

- Major surgery within 4 weeks prior to planned start of selpercatinib.

- Clinically significant active malabsorption syndrome or other condition likely to

affect gastrointestinal absorption of the study drug.

- Other malignancy unless nonmelanoma skin cancer, carcinoma in situ of the cervix or

other in situ cancers or a malignancy diagnosed greater than or equal to two years

previously and not currently active.

- Pregnancy or lactation.

- Prior treatment with a selective RET inhibitor (e.g. selpercatinib or pralsetinib).

Studien-Rationale

Primary outcome:

1. Event-Free Survival (EFS) (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)):
EFS by Investigator Assessment in the Primary Analysis Population



Secondary outcome:

1. EFS (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)):
EFS by investigator assessment in the overall population

2. Overall Survival (OS) (Time Frame - Randomization to death from any cause (estimated as up to 9 years)]):
OS

3. EFS (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)]):
EFS by blinded independent central review (BICR)

4. Time to Distant Disease Recurrence in the Central Nervous System (CNS) (Time Frame - Randomization to disease recurrence/progression or death from any cause (estimated as up to 7 years)):
Time to distant disease recurrence in the CNS by investigator assessment and BICR

5. Progression Free Survival on the Next Line of Treatment (PFS2) (Time Frame - Randomization to disease progression on the next line of treatment or death from any cause (estimated as up to 9 years)):
PFS2 by investigator assessment

6. Positive Predictive Value (PPV) of Rearranged during Transfection (RET) Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test (Time Frame - Baseline):
PPV of RET Tests from Investigator-Identified Laboratories with Respect to the Lilly-Designated RET Test

7. Mean Change from Baseline over Time in NSCLC Symptoms (Time Frame - Baseline to treatment discontinuation (estimated as up to 3 years)):
NSCLC symptoms will be measured using the 7-item NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ). The NSCLC-SAQ measures the severity/frequency of the following core symptoms: Cough, pain, dyspnea, fatigue, and appetite. Raw scores range from 0 to 4 and the total score ranges from 0-20. Higher scores represent worse symptoms.

8. Mean Change from Baseline over Time in Physical Function (Time Frame - Baseline to treatment discontinuation (estimated as up to 3 years)):
Physical function will be measured by the 5 physical function items in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) (also known as the EORTC IL 19 questionnaire). Raw scores range from 0-20. Higher scores indicate worst function.

Studien-Arme

  • Experimental: Selpercatinib
    Selpercatinib administered orally.
  • Placebo Comparator: Placebo
    Placebo administered orally.

Geprüfte Regime

  • Selpercatinib (LY3527723 / LOXO-292 / ):
    Administered orally.
  • Placebo:
    Administered orally.

Quelle: ClinicalTrials.gov


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