A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

February 27, 2026 updated by: Eli Lilly and Company

A Master Protocol to Evaluate the Long-Term Safety of Pirtobrutinib

The master protocol study J2N-MC-JZNY provides a framework to enable the evaluation of the long-term safety and efficacy of pirtobrutinib after completion of clinical studies evaluating pirtobrutinib. The clinical studies that will feed into this master protocol are referred to as originator studies. The master protocol will govern individual study-specific appendices (ISAs) that will represent participants from the individual, completed originator studies. These participants will have the opportunity to enter this study and continue to receive treatment or continue follow-up visits. Overall, the master protocol and the individual ISAs, when combined, define the investigations for this study.

Study Overview

Status

Status

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

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 (Estimated)

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.
787

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 4

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.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Phone Number: +61882044018
        • Principal Investigator:
          • Hui-Peng Lee
      • Melbourne, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Principal Investigator:
          • John Seymour
        • Contact:
          • Phone Number: 61396561158
      • Victoria, Australia, 3000
        • Recruiting
        • Linear Clinical Research
        • Principal Investigator:
          • Chan Cheah
        • Contact:
          • Phone Number: 61893467600
  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes - Hôtel Dieu
        • Principal Investigator:
          • Thomas Gastinne
        • Contact:
          • Phone Number: +33240083271
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS-AOU di Bologna-Policlinico S.Orsola-Malpighi
        • Principal Investigator:
          • Pier Luigi Zinzani
        • Contact:
          • Phone Number: +39512144042
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Principal Investigator:
          • Paolo Ghia
        • Contact:
          • Phone Number: +390226434797
  • Japan
      • Aichi-Ken, Japan, 4600001
        • Recruiting
        • Nagoya Medical Center
        • Principal Investigator:
          • Hirokazu Nagai
        • Contact:
          • Phone Number: 81120023812
      • Cho-ku, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Izutsu
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kaname Miyashita
      • Isehara, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital- Isehara Campus
        • Principal Investigator:
          • Yoshiaki Ogawa
        • Contact:
          • Phone Number: 81120023812
      • Miyagi-Ken, Japan, 9808574
        • Recruiting
        • Tohoku University Hospital
        • Principal Investigator:
          • Noriko Fukuhara
        • Contact:
          • Phone Number: 81120023812
      • Sapporo, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Principal Investigator:
          • Daigo Hashimoto
        • Contact:
          • Phone Number: 81120023812
  • Poland
      • Krakow, Poland, 30727
        • Recruiting
        • Pratia McM Krakow
        • Principal Investigator:
          • Wojciech Jurczak
        • Contact:
          • Phone Number: +48124003200
      • Warsaw, Poland, 02776
        • Recruiting
        • Instytut Hermatologii I Transfuzjologii
        • Principal Investigator:
          • Ewa Lech-Maranda
        • Contact:
          • Phone Number: +48223496334
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Ja Min Byun
        • Contact:
          • Phone Number: 821071243234
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital
        • Principal Investigator:
          • Talha Munir
        • Contact:
          • Phone Number: +441132433144
      • Oxford, United Kingdom, OX3 7LE
        • Not yet recruiting
        • Churchill Hospital
        • Principal Investigator:
          • Toby Eyre
        • Contact:
          • Phone Number: +447728268414
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital
        • Contact:
          • Phone Number: +441752431043
        • Principal Investigator:
          • David John Lewis
  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Not yet recruiting
        • Cancer Specialists, LLC
        • Principal Investigator:
          • Ayed Ayed
      • Miami, Florida, United States, 33136-1002
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Alvaro Alencar
        • Contact:
          • Phone Number: 954-265-6549
      • Sarasota, Florida, United States, 34232-6422
        • Recruiting
        • Florida Cancer Specialists
        • Principal Investigator:
          • Manish Patel
        • Contact:
          • Phone Number: 941-377-9993
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Not yet recruiting
        • The Emory Clinic
        • Principal Investigator:
          • Jonathon Cohen
        • Contact:
          • Phone Number: 404-778-3708
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Not yet recruiting
        • Northwestern University
        • Principal Investigator:
          • Shuo Ma
        • Contact:
          • Phone Number: 60611-3013
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Jennifer Brown
        • Contact:
          • Phone Number: 617-632-5847
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic- Minnesota
        • Principal Investigator:
          • Yucai Wang
        • Contact:
          • Phone Number: 507-284-2511
    • Nebraska
      • Omaha, Nebraska, United States, 69198
        • Recruiting
        • University Of Nebraska Medical Center
        • Contact:
          • Phone Number: 402-559-5166
        • Principal Investigator:
          • Matthew Lunning
    • New York
      • Ithaca, New York, United States, 14850
        • Recruiting
        • Cayuga Cancer Center
        • Contact:
          • Phone Number: 607-272-5414
        • Principal Investigator:
          • Cynthia Davis
      • Lake Success, New York, United States, 11042-1118
        • Recruiting
        • Northwell Health
        • Contact:
          • Phone Number: 516-734-8959
        • Principal Investigator:
          • Steven Allen
      • New York, New York, United States, 10065-6007
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
        • Principal Investigator:
          • Prioty Islam
      • New York, New York, United States, 10065-6007
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
        • Contact:
          • Phone Number: 646-608-4273
        • Principal Investigator:
          • Prioty Islam
    • North Carolina
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Phone Number: 919-684-8111
        • Principal Investigator:
          • Matthew McKinney
    • Ohio
      • Columbus, Ohio, United States, 43210-1063
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Jennifer Woyach
        • Contact:
          • Phone Number: 614-293-3196
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Hospital
        • Principal Investigator:
          • Sunita Nasta
        • Contact:
          • Phone Number: 215-662-3933
    • Tennessee
      • Nashville, Tennessee, United States, 37203-2659
        • Recruiting
        • Tennessee Oncology
        • Contact:
          • Phone Number: 615-524-4074
        • Principal Investigator:
          • Michael Byrne
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Contact:
          • Phone Number: 713-792-2860
        • Principal Investigator:
          • Michael Wang
    • Washington
      • Seattle, Washington, United States, 98104-3588
        • Recruiting
        • Swedish Cancer Institute
        • Principal Investigator:
          • Swathi Namburi
        • Contact:
          • Phone Number: 98104-3588
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3548
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Nirav Shah
        • Contact:
          • Phone Number: 414-805-4600

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Are participating in an eligible Lilly sponsored clinical study evaluating pirtobrutinib.

Exclusion Criteria:

Exclusion criteria are defined in each ISA.

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: N/A
  • Interventional Model: Single Group 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: JZ01 Pirtobrutinib

Participants receive pirtobrutinib as defined in the originator study (LOXO-BTK-18001/J2N-OX-JZNA).

Pirtobrutinib administered orally.
Drug: Pirtobrutinib
Administered orally.
Other Names:
  • LOXO-305
  • LY3527727

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
Time Frame
Percentage of Participants with a Grade ≥3 treatment-emergent AEs
Time Frame: Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier
Time from the Date of the First Dose of Study Intervention (Study Day 1) through 30 Days (+ 7-day window) After the Date of the Last Dose of Study Intervention or The First Date Starting a New Anticancer Therapy, whichever is Earlier

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
Overall Survival
Time Frame: Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 Months)
Overall survival is defined as the time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause.
Time from randomization in a randomized Originator study, or from the first dose in a non-randomized Originator study, until death from any cause (Up to 93 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.
Eli Lilly and Company

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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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.
May 20, 2025

Primary Completion (Estimated)

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.
May 1, 2030

Study Completion (Estimated)

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.
December 1, 2032

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).
March 6, 2025

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.
March 13, 2025

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.
March 14, 2025

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 2, 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 27, 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

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.
  • 27202
  • J2N-MC-JZ01 (Other Identifier: Eli Lilly and Company)
  • 2024-517760-29-00 (Ctis)
  • J2N-MC-JZNY (Other Identifier: Eli Lilly and Company)
  • J2N-MC-JZ02 (Other Identifier: Eli Lilly and Company)
  • J2N-MC-JZ03 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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