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

February 12, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
223

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico
      • La Rioja, Argentina, F5300COE
        • Centro Oncologico Riojano Integral (CORI)
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01509-010
        • Hospital A. C. Camargo
  • Costa Rica
      • San José, Costa Rica, 10103
        • Clinica CIMCA
  • France
      • Bordeaux, France, 33000
        • Institut Bergonie CLCC Bordeaux
      • Boulogne-Billancourt, France, 92100
        • Hôpital Ambroise Paré - Boulogne-Billancourt
      • Bron, France, 69677
        • Hôpital Louis Pradel, Hospices Civils de Lyon
      • Lille, France, 59000
        • CHRU Lille Service de Pneumologie et Oncologie Thoracique
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75018
        • Hopital Bichat Claude Bernard
      • Rennes, France, 35033
        • Hôpital de Pontchaillou
      • Saint-Herblain, France, 44805
        • Ico Rene Gauducheau
      • Strasbourg, France, 67091
        • CHU Strasbourg - Nouvel Hôpital Civil
      • Toulouse, France, 31100
        • CHU de Toulouse - Hopital Larrey
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13
      • Gauting, Germany, 82131
        • Asklepios-Fachkliniken Muenchen-Gauting
      • Oldenburg, Germany, 26121
        • Pius-Hospital
      • Schweinfurt, Germany, 97422
        • Leopoldina-Krankenhaus Medizinische Klinik II
      • Stuttgart, Germany, 70376
        • Klinik Schillerhöhe
  • Ireland
      • Dublin, Ireland, D08 HNY1
        • St. James Hospital
  • Italy
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Ospedale Clinicizzato SS Annunziata
    • Apulia
      • Bari, Apulia, Italy, 70124
        • IRCCS Giovanni Paolo II Istituto Oncologico
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italy, 48100
        • Ospedale Provinciale Santa Maria Delle Croci
    • Lazio
      • Rome, Lazio, Italy, 00184
        • AZ. Ospedaliera San Giovanni - Addolorata
      • Rome, Lazio, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milan, Lombardy, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20141
        • Istituto Europeo di Oncologia
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
    • Veneto
      • Padua, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
      • Verona, Veneto, Italy, 37126
        • A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento
  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hyōgo, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Yamaguchi, Japan, 755-0241
        • National Hospital Organization Yamaguchi - Ube Medical Center
  • Mexico
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 03100
        • Health Pharma Professional Research
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • NKI/AvL
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
  • Norway
      • Oslo, Norway, 0450
        • Oslo universitetssykehus HF, Ullevål, Kreftsenteret
  • Panama
      • Panama City, Panama, 0801
        • Hemato Oncología de Panamá Especializada
  • Poland
      • Warsaw, Poland, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
  • Portugal
      • Porto, Portugal, 4200-072
        • IPO do Porto
  • South Korea
      • Goyang-si, South Korea, 10408
        • National Cancer Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
      • Zaragoza, Spain, 50009
        • Hosp Clinico Univ Lozano Blesa
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Insititut Catala D'Oncologia
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • LA Coruna
      • A Coruña, LA Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruna
  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset, Solna
  • Switzerland
      • Zurich, Switzerland, 8091
        • Universitatsspital Zurich
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01060
        • Adana City Hospital, Medical Oncology
      • Ankara, Turkey (Türkiye), 06490
        • Ankara Bilkent City Hospital
      • Kar?iyaka, Turkey (Türkiye), 35575
        • ?zmir Medical Point
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, SE1 9RT
        • Guys & St Thomas Hospital
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pralsetinib
Participants randomized to the Experimental Arm will receive Pralsetinib
Drug: Pralsetinib
Administered orally
Other Names:
  • BLU-667
Active Comparator: Platinum-based chemotherapy with or without pembrolizumab

Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology)

Nonsquamous histology

  • Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance.
  • Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance.

Squamous histology

  • Carboplatin or cisplatin / gemcitabine
  • Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab
Drug: Pembrolizumab
Administered IV
Drug: Paclitaxel
Administered IV
Drug: Carboplatin
Administered IV
Drug: Cisplatin
Administered IV
Drug: Pemetrexed
Administered IV
Drug: Gemcitabine
Administered IV
Drug: Nab-Paclitaxel
Administered IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS)
Time Frame: Up to approximately 50 months
PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Up to approximately 50 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arm A vs Arm B: Objective Response Rate (ORR)
Time Frame: Up to approximately 50 months
ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages have been rounded off.
Up to approximately 50 months
Arm A vs Arm B: Overall Survival (OS)
Time Frame: From randomization to death (up to approximately 50 months)
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
From randomization to death (up to approximately 50 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 50 months
An AE is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Up to approximately 50 months
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Time Frame: Baseline up to 50 months
ECOG is a 6-point scale (0-5) used to assess participants functional status, where, 0= Fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work; 2= ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.
Baseline up to 50 months
Arm A vs Arm B: Duration of Response (DOR)
Time Frame: Up to approximately 50 months
DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD or death from any cause, whichever occurred first, as determined by the investigator with the use of RECIST v1.1. CR was defined as disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate median DOR. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Up to approximately 50 months
Arm A vs Arm B: Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 50 months
CBR was defined as the percentage of participants who experienced the best response of stable disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by investigator with use of RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off.
Up to approximately 50 months
Arm A vs Arm B: Disease Control Rate (DCR)
Time Frame: Up to approximately 50 months
DCR was defined as the percentage of participants who experienced the best response of CR, or PR, or SD, as assessed by investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target lesions or any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. 95% CI for rates were constructed using the Clopper-Pearson method. Percentages are rounded off.
Up to approximately 50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO42864
  • 2019-002463-10 (EudraCT Number)
  • BLU-667-2303 (Registry Identifier: CT.Gov)
  • 2023-505035-12-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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