Neoplasms Clinical Trial
— AcceleRET-LungOfficial title:
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer
Verified date | April 2024 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
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,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03826043 -
THrombo-Embolic Event in Onco-hematology
|
N/A | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT01938846 -
BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06058312 -
Individual Food Preferences for the Mediterranean Diet in Cancer Patients
|
N/A | |
Completed |
NCT03308942 -
Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants
|
Phase 2 | |
Recruiting |
NCT06018311 -
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads
|
N/A | |
Withdrawn |
NCT05431439 -
Omics of Cancer: OncoGenomics
|
||
Completed |
NCT01343043 -
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma
|
Phase 1 | |
Completed |
NCT01938638 -
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT05514444 -
Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)
|
Phase 1 | |
Recruiting |
NCT02292641 -
Beyond TME Origins
|
N/A | |
Terminated |
NCT00954512 -
Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04958239 -
A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)
|
Phase 1 | |
Recruiting |
NCT04627376 -
Multimodal Program for Cancer Related Cachexia Prevention
|
N/A | |
Completed |
NCT01222728 -
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT06035549 -
Resilience in East Asian Immigrants for Advance Care Planning Discussions
|
N/A | |
Recruiting |
NCT06004466 -
Noninvasive Internal Jugular Venous Oximetry
|
||
Completed |
NCT02909348 -
Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab
|