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

PHASE3CompletedINTERVENTIONAL
Enrollment

223

Participants

Timeline

Start Date

July 24, 2020

Primary Completion Date

January 27, 2025

Study Completion Date

January 27, 2025

Conditions
RET-fusion Non Small Cell Lung CancerLung NeoplasmCarcinoma, Non-Small-Cell LungRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseaseCarcinoma, BronchogenicBronchial DiseasesHead and Neck NeoplasmsAdenocarcinomaCarcinomaNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve Tissue
Interventions
DRUG

Pralsetinib

Administered orally

DRUG

Carboplatin

Administered IV

DRUG

Cisplatin

Administered IV

DRUG

Pemetrexed

Administered IV

DRUG

Pembrolizumab

Administered IV

DRUG

Gemcitabine

Administered IV

DRUG

Paclitaxel

Administered IV

DRUG

Nab-Paclitaxel

Administered IV

Trial Locations (68)

2065

Royal North Shore Hospital, St Leonards

2650

UZ Antwerpen, Edegem

8091

UniversitätsSpital Zürich, Zurich

10103

Clinica CIMCA, San José

10408

National Cancer Center, Goyang-si

13273

Institut Paoli Calmettes, Marseille

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

26121

Pius-Hospital, Oldenburg

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28050

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

31100

CHU de Toulouse - Hôpital Larrey, Toulouse

33000

Institut Bergonie CLCC Bordeaux, Bordeaux

35033

Hopital de Pontchaillou, Rennes

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

35575

?zmir Medical Point, Kar?iyaka

37126

A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento, Verona

39008

Hospital Universitario Marques de Valdecilla, Santander

48100

Ospedale Provinciale Santa Maria Delle Croci, Ravenna

50009

Hosp Clinico Univ Lozano Blesa, Zaragoza

56124

Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello, Pisa

59000

CHRU Lille Service de Pneumologie et Oncologie Thoracique, Lille

66100

Ospedale Clinicizzato SS Annunziata, Chieti

67091

CHU Strasbourg - Nouvel Hopital Civil, Strasbourg

70376

Klinik Schillerhöhe, Stuttgart

75018

Hopital Bichat Claude Bernard, Paris

75970

Hopital Tenon, Paris

80131

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli

82131

Asklepios-Fachkliniken Muenchen-Gauting, Gauting

92100

Hôpital Ambroise Paré - Boulogne-Billancourt, Boulogne-Billancourt

94805

Institut Gustave Roussy, Villejuif

97422

Leopoldina-Krankenhaus Medizinische Klinik II, Schweinfurt

C1280AEB

Hospital Britanico, Buenos Aires

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

01509-010

Hospital A. C. Camargo, São Paulo

01307

Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13, Dresden

D08 HNY1

St. James Hospital, Dublin

00144

Istituto Nazionale Tumori Regina Elena, Rome

00184

AZ. Ospedaliera San Giovanni - Addolorata, Rome

812-8582

Kyushu University Hospital, Fukuoka

670-8520

National Hospital Organization Himeji Medical Center, Hyōgo

541-8567

Osaka International Cancer Institute, Osaka

573-1191

Kansai Medical University Hospital, Osaka

113-8431

Juntendo University Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

755-0241

National Hospital Organization Yamaguchi - Ube Medical Center, Yamaguchi

03100

Health Pharma Professional Research, Mexico City

1066 CX

NKI/AvL, Amsterdam

6229 HX

Maastricht University Medical Center, Maastricht

0801

Hemato Oncología de Panamá Especializada, Panama City

02-781

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad, Warsaw

4200-072

IPO do Porto, Porto

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08908

Insititut Catala D'Oncologia, L'Hospitalet de Llobregat

08035

Hospital Universitari Vall d'Hebron, Barcelona

171 76

Karolinska Universitetssjukhuset, Solna, Stockholm

01060

Adana City Hospital, Medical Oncology, Adana

06490

Ankara Bilkent City Hospital, Ankara

CF14 2TL

Velindre Cancer Centre, Cardiff

LE1 5WW

Leicester Royal Infirmary, Leicester

N7 9NH

University College Hospital, London

SE1 9RT

Guys & St Thomas Hospital, London

SW3 6JJ

Royal Marsden Hospital, London

M2O 4BX

Christie Hospital Nhs Trust, Manchester

SM2 5PT

Royal Marsden Hospital, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04222972 - A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) | Biotech Hunter | Biotech Hunter