Lung Cancer Clinical Trial

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

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. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT04222972

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 122 Locations for this study

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UC Irvine Medical Center
Orange California, 92868, United States
Southern California Kaiser Permanente
San Diego California, 92108, United States
Sylvester Comprehensive Cancer Center; University of Miami School of Medicine
Miami Florida, 33136, United States
University of Maryland Marlene and Stewart Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
University of Michigan Hospital
Ann Arbor Michigan, 48109, United States
UPMC - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Health Science Center
Dallas Texas, 75390, United States
Millennium Research & Clinical Development
Houston Texas, 77090, United States
Royal North Shore Hospital; Department of Medical Oncology
St Leonards New South Wales, 2065, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Institut Jules Bordet; Pulmonary Oncology
Anderlecht , 1070, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
Ste. Foy Quebec, G1V 4, Canada
Clinica CIMCA
San José , 10103, Costa Rica
Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed
København Ø , 2100, Denmark
Helsinki University Central Hospital; Dept of Oncology
Helsinki , 00250, Finland
Institut Bergonie CLCC Bordeaux
Bordeaux , 33000, France
Hôpital Ambroise Paré - Boulogne-Billancourt
Boulogne Billancourt , 92100, France
Hôpital Louis Pradel, Hospices Civils de Lyon
Bron , 69677, France
CHRU Lille Service de Pneumologie et Oncologie Thoracique
Lille , 59000, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille , 13273, France
Hopital Bichat Claude Bernard; Oncologie Serv.
Paris , 75018, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
Hopital Tenon;Pneumologie
Paris , 75970, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes , 35033, France
Ico Rene Gauducheau; Oncologie
Saint Herblain , 44805, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg , 67091, France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
Toulouse cedex 9 , 31100, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13
Dresden , 01307, Germany
Klinikum Esslingen
Esslingen , 73730, Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting , 82131, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
München , 81377, Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg , 26121, Germany
Leopoldina-Krankenhaus Medizinische Klinik II
Schweinfurt , 97422, Germany
Klinik Schillerhöhe; Pneumologische Onkologie
Stuttgart , 70376, Germany
St. James Hospital; Oncology
Dublin , 8, Ireland
Shaare Zedek Medical Center; Oncology Dept
Jerusalem , 91031, Israel
Meir Medical Center; Oncology
Kfar-Saba , 44281, Israel
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv , 64239, Israel
Ospedale Clinicizzato SS Annunziata
Chieti Abruzzo, 66100, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Università degli Studi della Campania Luigi Vanvitelli
Napoli Campania, 80131, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
Ravenna Emilia-Romagna, 48100, Italy
Istituto Nazionale Tumori Regina Elena
Roma Lazio, 00144, Italy
AZ. Ospedaliera San Giovanni - Addolorata
Roma Lazio, 00184, Italy
Azienda Ospedaliera Sant'Andrea
Roma Lazio, 00189, Italy
Irccs Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
A.O.U. Maggiore della Carità
Novara Piemonte, 28100, Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari Puglia, 70124, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
Pisa Toscana, 56124, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia
Verona Veneto, 37126, Italy
Nagoya University Hospital
Aichi , 466-8, Japan
Hirosaki University Hospital
Aomori , 036-8, Japan
National Cancer Center Hospital East
Chiba , 277-8, Japan
Ehime University Hospital
Ehime , 791-0, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Kurume University Hospital
Fukuoka , 830-0, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
Iwate Medical University Hospital
Iwate , 028-3, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Kurashiki Central Hospital
Okayama , 710-8, Japan
Osaka City General Hospital
Osaka , 534-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Kansai Medical University Hospital
Osaka , 573-1, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi , 755-0, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
COI Centro Oncologico Internacional SAPI de CV
Tijuana BAJA California SUR, 22010, Mexico
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Oncologico Potosino
San Luis Potosí SAN LUIS Potosi, 78209, Mexico
NKI/AvL
Amsterdam , 1066 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland , 1023, New Zealand
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Oslo , 0450, Norway
Hemato Oncología de Panamá Especializada
Panama City , 0801, Panama
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Warszawa , 02-78, Poland
Hospital Garcia de Orta; Servico de Pneumologia
Almada , 2801-, Portugal
Hospital de Braga; Serviço de Pneumologia
Braga , 4710-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
Vila Nova de Gaia , 4434-, Portugal
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo Asturias, 33011, Spain
Hospital Universitario Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander Cantabria, 39008, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña LA Coruña, 15006, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda Madrid, 28222, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clínic. Barcelona
Barcelona , 08036, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid , 28050, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital General Universitario de Valencia; Servicio de oncologia
Valencia , 46014, Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza , 50009, Spain
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
Stockholm , 171 7, Sweden
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
Adana City Hospital, Medical Oncology
Adana , 01060, Turkey
Adana Baskent University Hospital; Medical Oncology
Adana , 01120, Turkey
Ankara City Hospital
Ankara , 06490, Turkey
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul , 34214, Turkey
İzmir Medical Park; Onkoloji
Izmır , 35575, Turkey
Velindre Cancer Centre; Oncology Dept
Cardiff , CF14 , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester , LE1 5, United Kingdom
University College Hospital; Department of Oncology
London , N7 9N, United Kingdom
Guys & St Thomas Hospital; Department of Oncology
London , SE1 9, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London , SW3 6, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester , M2O 4, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT04222972

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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