Trial Title:
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID:
NCT04222972
Condition:
RET-fusion Non Small Cell Lung Cancer
Lung Neoplasm
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Disease
Carcinoma, Bronchogenic
Bronchial Diseases
Head and Neck Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Thoracic Neoplasms
Respiratory Tract Neoplasms
Carcinoma, Bronchogenic
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Pemetrexed
Pralsetinib
Conditions: Keywords:
Advanced Non-Small Cell Lung Cancer
RET Lung
RET Mutation
RET Alteration
RET Positive
RET Inhibitor
RET Altered
RET Rearrangement
RET NSCLC
RET-Rearranged NSCLC
RET Fusion
RET Fusion Lung Cancer
M918T
TRIM33-RET
Lung Cancer Mutation
BLU 667
Pralsetinib
RET Tyrosine Kinase
RET Gene Mutation
RET Kinase
Advanced Lung Cancer
Metastatic Lung Cancer
KIF5B-RET
CCDC6-RET
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pralsetinib
Description:
Administered orally
Arm group label:
Pralsetinib
Other name:
BLU-667
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Intervention type:
Drug
Intervention name:
Nab-Paclitaxel
Description:
Administered IV
Arm group label:
Platinum-based chemotherapy with or without pembrolizumab
Summary:
This is an international, randomized, open-label, Phase 3 study designed to evaluate
whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when
compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list
of standard of care treatments, as measured primarily by progression free survival (PFS),
for participants with RET fusion-positive metastatic NSCLC who have not previously
received systemic anticancer therapy for metastatic disease.
Criteria for eligibility:
Criteria:
Inclusion criteria:
- Participant has pathologically confirmed, definitively diagnosed, locally advanced
(not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has
not been treated with systemic anticancer therapy for metastatic disease.
- Participant must have a documented RET-fusion
- Participant has measurable disease based on RECIST 1.1 as determined by the local
site Investigator/radiology assessment.
- Participant has an ECOG Performance Status of 0 or 1.
- Participant should not have received any prior anticancer therapy for metastatic
disease.
- Participants can have received previous anticancer therapy (except a selective
RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced
an interval of at least ≥ 6 months from completion of therapy to recurrence.
- Participants that received previous immune checkpoint inhibitors in the
adjuvant or consolidation following chemoradiation are not allowed to receive
pembrolizumab if randomized in Arm B
- Participant is an appropriate candidate for and agrees to receive 1 of the
Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
- For women of childbearing potential: participants who agree to remain abstinent
(refrain from heterosexual intercourse) or use contraception.
- For men: participants who agree to remain abstinent (refrain from heterosexual
intercourse) or use a condom and agree to refrain from donating sperm.
Exclusion criteria:
- Participant's tumor has any additional known primary driver alterations other than
RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators
should discuss enrollment with Sponsor designee regarding co-mutations.
- Participant previously received treatment with a selective RET inhibitor.
- Participant received radiotherapy or radiosurgery to any site within 14 days before
randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before
randomization.
- Participant with a history of pneumonitis within the last 12 months.
- Participant has CNS metastases or a primary CNS tumor that is associated with
progressive neurological symptoms or requires increasing doses of corticosteroids to
control the CNS disease. If a participant requires corticosteroids for management of
CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
- Participant has had a history of another primary malignancy that has been diagnosed
or required therapy within the past 3 years prior to randomization.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC Irvine Medical Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Facility:
Name:
Southern California Kaiser Permanente
Address:
City:
San Diego
Zip:
92108
Country:
United States
Facility:
Name:
Hospital Britanico; Oncologia
Address:
City:
Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Facility:
Name:
Centro Oncologico Riojano Integral (CORI)
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Facility:
Name:
Royal North Shore Hospital; Department of Medical Oncology
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Facility:
Name:
UZ Antwerpen
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Facility:
Name:
Liga Norte Riograndense Contra O Câncer
Address:
City:
Natal
Zip:
59040150
Country:
Brazil
Facility:
Name:
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Address:
City:
Ijui
Zip:
98700-000
Country:
Brazil
Facility:
Name:
Hospital Sao Lucas - PUCRS
Address:
City:
Porto Alegre
Zip:
90610-000
Country:
Brazil
Facility:
Name:
Instituto do Cancer do Estado de Sao Paulo - ICESP
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Facility:
Name:
Hospital A. C. Camargo; Oncologia
Address:
City:
Sao Paulo
Zip:
01509-010
Country:
Brazil
Facility:
Name:
Clinica CIMCA
Address:
City:
San José
Zip:
10103
Country:
Costa Rica
Facility:
Name:
Institut Bergonie CLCC Bordeaux
Address:
City:
Bordeaux
Zip:
33000
Country:
France
Facility:
Name:
Hôpital Ambroise Paré - Boulogne-Billancourt
Address:
City:
Boulogne Billancourt
Zip:
92100
Country:
France
Facility:
Name:
Hôpital Louis Pradel, Hospices Civils de Lyon
Address:
City:
Bron
Zip:
69677
Country:
France
Facility:
Name:
CHRU Lille Service de Pneumologie et Oncologie Thoracique
Address:
City:
Lille
Zip:
59000
Country:
France
Facility:
Name:
Institut Paoli Calmettes; Oncologie Medicale
Address:
City:
Marseille
Zip:
13273
Country:
France
Facility:
Name:
Hopital Bichat Claude Bernard; Oncologie Serv.
Address:
City:
Paris
Zip:
75018
Country:
France
Facility:
Name:
Hopital Tenon;Pneumologie
Address:
City:
Paris
Zip:
75970
Country:
France
Facility:
Name:
Hopital de Pontchaillou; Service de Pneumologie
Address:
City:
Rennes
Zip:
35033
Country:
France
Facility:
Name:
Ico Rene Gauducheau; Oncologie
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Facility:
Name:
CHU Strasbourg - Nouvel Hopital Civil
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Facility:
Name:
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Address:
City:
Toulouse cedex 9
Zip:
31100
Country:
France
Facility:
Name:
Institut Gustave Roussy; Departement Oncologie Medicale
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Facility:
Name:
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Address:
City:
Oldenburg
Zip:
26121
Country:
Germany
Facility:
Name:
Leopoldina-Krankenhaus Medizinische Klinik II
Address:
City:
Schweinfurt
Zip:
97422
Country:
Germany
Facility:
Name:
Klinik Schillerhöhe; Pneumologische Onkologie
Address:
City:
Stuttgart
Zip:
70376
Country:
Germany
Facility:
Name:
St. James Hospital; Oncology
Address:
City:
Dublin
Zip:
D08 HNY1
Country:
Ireland
Facility:
Name:
Ospedale Clinicizzato SS Annunziata
Address:
City:
Chieti
Zip:
66100
Country:
Italy
Facility:
Name:
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Facility:
Name:
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
Address:
City:
Ravenna
Zip:
48100
Country:
Italy
Facility:
Name:
Istituto Nazionale Tumori Regina Elena
Address:
City:
Roma
Zip:
00144
Country:
Italy
Facility:
Name:
AZ. Ospedaliera San Giovanni - Addolorata
Address:
City:
Roma
Zip:
00184
Country:
Italy
Facility:
Name:
Irccs Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Facility:
Name:
Istituto Europeo Di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Facility:
Name:
IRCCS Giovanni Paolo II Istituto Oncologico
Address:
City:
Bari
Zip:
70124
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
Address:
City:
Pisa
Zip:
56124
Country:
Italy
Facility:
Name:
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Address:
City:
Padova
Zip:
35128
Country:
Italy
Facility:
Name:
A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia
Address:
City:
Verona
Zip:
37126
Country:
Italy
Facility:
Name:
Nagoya University Hospital
Address:
City:
Aichi
Zip:
466-8560
Country:
Japan
Facility:
Name:
Hirosaki University Hospital
Address:
City:
Aomori
Zip:
036-8563
Country:
Japan
Facility:
Name:
Ehime University Hospital
Address:
City:
Ehime
Zip:
791-0295
Country:
Japan
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Facility:
Name:
National Hospital Organization Himeji Medical Center
Address:
City:
Hyogo
Zip:
670-8520
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Kanagawa
Zip:
241-8515
Country:
Japan
Facility:
Name:
Osaka City General Hospital
Address:
City:
Osaka
Zip:
534-0021
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka
Zip:
541-8567
Country:
Japan
Facility:
Name:
Kansai Medical University Hospital
Address:
City:
Osaka
Zip:
573-1191
Country:
Japan
Facility:
Name:
Juntendo University Hospital
Address:
City:
Tokyo
Zip:
113-8431
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Facility:
Name:
National Hospital Organization Yamaguchi - Ube Medical Center
Address:
City:
Yamaguchi
Zip:
755-0241
Country:
Japan
Facility:
Name:
National Cancer Center
Address:
City:
Goyang-si
Zip:
10408
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Facility:
Name:
Health Pharma Professional Research
Address:
City:
Cdmx
Zip:
03100
Country:
Mexico
Facility:
Name:
NKI/AvL
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Facility:
Name:
Maastricht University Medical Center
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Facility:
Name:
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Address:
City:
Oslo
Zip:
0450
Country:
Norway
Facility:
Name:
Hemato Oncología de Panamá Especializada
Address:
City:
Panama City
Zip:
0801
Country:
Panama
Facility:
Name:
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Facility:
Name:
IPO do Porto; Servico de Oncologia Medica
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Facility:
Name:
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
Address:
City:
Vila Nova de Gaia
Zip:
4434-502
Country:
Portugal
Facility:
Name:
Insititut Catala D'Oncologia
Address:
City:
Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Facility:
Name:
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Address:
City:
Santander
Zip:
39008
Country:
Spain
Facility:
Name:
Complejo Hospitalario Universitario A Coruña
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28009
Country:
Spain
Facility:
Name:
Hospital Ramon y Cajal; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Facility:
Name:
Hospital Regional Universitario de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Facility:
Name:
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Address:
City:
Zaragoza
Zip:
50009
Country:
Spain
Facility:
Name:
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Facility:
Name:
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Facility:
Name:
Adana City Hospital, Medical Oncology
Address:
City:
Adana
Zip:
01060
Country:
Turkey
Facility:
Name:
Ankara Bilkent City Hospital
Address:
City:
Ankara
Zip:
06490
Country:
Turkey
Facility:
Name:
?zmir Medical Point; Oncology
Address:
City:
Kar?iyaka
Zip:
35575
Country:
Turkey
Facility:
Name:
Velindre Cancer Centre; Oncology Dept
Address:
City:
Cardiff
Zip:
CF14 2TL
Country:
United Kingdom
Facility:
Name:
Leicester Royal Infirmary; Dept. of Medical Oncology
Address:
City:
Leicester
Zip:
LE1 5WW
Country:
United Kingdom
Facility:
Name:
University College Hospital; Department of Oncology
Address:
City:
London
Zip:
N7 9NH
Country:
United Kingdom
Facility:
Name:
Guys & St Thomas Hospital; Department of Oncology
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Facility:
Name:
Royal Marsden Hospital; Dept of Med-Onc
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Facility:
Name:
Christie Hospital Nhs Trust; Medical Oncology
Address:
City:
Manchester
Zip:
M2O 4BX
Country:
United Kingdom
Facility:
Name:
Royal Marsden Hospital; Dept of Medical Oncology
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Start date:
July 24, 2020
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04222972
