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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04222972
Other study ID # BO42864
Secondary ID 2019-002463-10BL
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 24, 2020
Est. completion date June 30, 2025

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 223
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Pralsetinib
Administered orally
Carboplatin
Administered IV
Cisplatin
Administered IV
Pemetrexed
Administered IV
Pembrolizumab
Administered IV
Gemcitabine
Administered IV
Paclitaxel
Administered IV
Nab-Paclitaxel
Administered IV

Locations

Country Name City State
Argentina Hospital Britanico; Oncologia Buenos Aires
Argentina Centro Oncologico Korben; Oncology Ciudad Autonoma Buenos Aires
Argentina Centro Oncologico Riojano Integral (CORI) La Rioja
Australia Flinders Medical Centre Bedford Park South Australia
Australia Royal North Shore Hospital; Department of Medical Oncology St Leonards New South Wales
Belgium UZ Antwerpen Edegem
Brazil Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda Ijui RS
Brazil Liga Norte Riograndense Contra O Câncer Natal RN
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital A. C. Camargo; Oncologia Sao Paulo SP
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP Sao Paulo SP
Costa Rica Clinica CIMCA San José
France Institut Bergonie CLCC Bordeaux Bordeaux
France Hôpital Ambroise Paré - Boulogne-Billancourt Boulogne Billancourt
France Hôpital Louis Pradel, Hospices Civils de Lyon Bron
France CHRU Lille Service de Pneumologie et Oncologie Thoracique Lille
France Institut Paoli Calmettes; Oncologie Medicale Marseille
France Hopital Bichat Claude Bernard; Oncologie Serv. Paris
France Hopital Tenon;Pneumologie Paris
France Hopital de Pontchaillou; Service de Pneumologie Rennes
France Ico Rene Gauducheau; Oncologie Saint Herblain
France CHU Strasbourg - Nouvel Hopital Civil Strasbourg
France CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique Toulouse cedex 9
France Institut Gustave Roussy; Departement Oncologie Medicale Villejuif
Germany Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13 Dresden
Germany Asklepios-Fachkliniken Muenchen-Gauting; Onkologie Gauting
Germany Pius-Hospital; Klinik fuer Haematologie und Onkologie Oldenburg
Germany Leopoldina-Krankenhaus Medizinische Klinik II Schweinfurt
Germany Klinik Schillerhöhe; Pneumologische Onkologie Stuttgart
Ireland St. James Hospital; Oncology Dublin
Italy IRCCS Giovanni Paolo II Istituto Oncologico Bari Puglia
Italy Ospedale Clinicizzato SS Annunziata Chieti Abruzzo
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milano Lombardia
Italy Irccs Ospedale San Raffaele Milano Lombardia
Italy Istituto Europeo Di Oncologia Milano Lombardia
Italy Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale Napoli Campania
Italy IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II Padova Veneto
Italy Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare Pisa Toscana
Italy Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica Ravenna Emilia-Romagna
Italy AZ. Ospedaliera San Giovanni - Addolorata Roma Lazio
Italy Istituto Nazionale Tumori Regina Elena Roma Lazio
Italy A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia Verona Veneto
Japan Nagoya University Hospital Aichi
Japan Hirosaki University Hospital Aomori
Japan Ehime University Hospital Ehime
Japan Kyushu University Hospital Fukuoka
Japan National Hospital Organization Himeji Medical Center Hyogo
Japan Kanagawa Cancer Center Kanagawa
Japan Kansai Medical University Hospital Osaka
Japan Osaka City General Hospital Osaka
Japan Osaka International Cancer Institute Osaka
Japan Juntendo University Hospital Tokyo
Japan The Cancer Institute Hospital of JFCR Tokyo
Japan National Hospital Organization Yamaguchi - Ube Medical Center Yamaguchi
Korea, Republic of National Cancer Center Goyang-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Mexico Health Pharma Professional Research Cdmx Mexico CITY (federal District)
Netherlands NKI/AvL Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Maastricht University Medical Center Maastricht
Norway Oslo universitetssykehus HF, Ullevål, Kreftsenteret Oslo
Panama Hemato Oncología de Panamá Especializada Panama City
Poland Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers Warszawa
Portugal Hospital Garcia de Orta; Servico de Pneumologia Almada
Portugal IPO do Porto; Servico de Oncologia Medica Porto
Portugal Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E Vila Nova de Gaia
Spain Complejo Hospitalario Universitario A Coruña A Coruña LA Coruña
Spain Hospital Universitario Germans Trias i Pujol Badalona Barcelona
Spain Hospital Clínic. Barcelona Barcelona
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Insititut Catala D'Oncologia Hospitalet de Llobregat Barcelona
Spain HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia Madrid
Spain Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid
Spain Hospital Ramon y Cajal; Servicio de Oncologia Madrid
Spain Hospital Regional Universitario de Malaga Malaga
Spain Hospital Univ. Central de Asturias; Servicio de Oncologia Oviedo Asturias
Spain Hospital Universitario Marques de Valdecilla; Servicio de Oncologia Santander Cantabria
Spain Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla
Spain Hospital General Universitario de Valencia; Servicio de oncologia Valencia
Spain Hosp Clinico Univ Lozano Blesa; División De Oncología Médica Zaragoza
Sweden Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01 Stockholm
Switzerland UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie Zürich
Turkey Adana Baskent University Hospital; Medical Oncology Adana
Turkey Adana City Hospital, Medical Oncology Adana
Turkey Ankara Bilkent City Hospital Ankara
Turkey Medipol Mega Üniversite Hastanesi Göztepe Istanbul
Turkey ?zmir Medical Point; Oncology Kar?iyaka
Turkey Medical Park Seyhan Hospital; Oncology Department Seyhan
United Kingdom Velindre Cancer Centre; Oncology Dept Cardiff
United Kingdom Leicester Royal Infirmary; Dept. of Medical Oncology Leicester
United Kingdom Guys & St Thomas Hospital; Department of Oncology London
United Kingdom Royal Marsden Hospital; Dept of Med-Onc London
United Kingdom University College Hospital; Department of Oncology London
United Kingdom Christie Hospital Nhs Trust; Medical Oncology Manchester
United Kingdom Royal Marsden Hospital; Dept of Medical Oncology Sutton
United States UC Irvine Medical Center Orange California
United States Southern California Kaiser Permanente San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Costa Rica,  France,  Germany,  Ireland,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Panama,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, whichever occurs first. Estimated at up to 32 months
Secondary Overall Response Rate (ORR) Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) on two consecutive occasions = 4 weeks apart, as assessed by investigator according to RECIST 1.1. Estimated at up to 32 months
Secondary Overall Survival (OS) Defined as the time from randomisation date to death due to any cause. Estimated at approximately 32 months
Secondary Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) The intensity of Adverse Events (AEs) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Secondary Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Further characterising safety and tolerability. Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Secondary Duration of Response (DOR) Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by investigator according to RECIST v1.1. Estimated at up to 32 months
Secondary Clinical Benefit Rate (CBR) Defined as the proportion of participants who experience a best response of Stable Disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator according to RECIST v1.1. Estimated at up to 32 months
Secondary Disease Control Rate (DCR) Defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1. Estimated at up to 32 months
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