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Submitted URL: https://e.endpointsnews.com/t/t-l-vthhuc-jrhhyhfa-jt/
Effective URL: https://classic.clinicaltrials.gov/ct2/show/NCT05680922
Submission: On November 13 via api from US — Scanned from DE
Effective URL: https://classic.clinicaltrials.gov/ct2/show/NCT05680922
Submission: On November 13 via api from US — Scanned from DE
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This is the classic website, which will be retired eventually. Please visit the
modernized ClinicalTrials.gov instead.
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GLOSSARY
Study record managers: refer to the Data Element Definitions if submitting
registration or results information.
Search for terms
* Accepts healthy volunteers
A type of eligibility criteria that indicates whether people who do not have
the condition/disease being studied can participate in that clinical study.
* Active comparator arm
An arm type in which a group of participants receives an
intervention/treatment considered to be effective (or active) by health care
providers.
* Adverse event
An unfavorable change in the health of a participant, including abnormal
laboratory findings, that happens during a clinical study or within a certain
amount of time after the study has ended. This change may or may not be
caused by the intervention/treatment being studied.
* Age or age group
A type of eligibility criteria that indicates the age a person must be to
participate in a clinical study. This may be indicated by a specific age or
the following age groups:
The age groups are:
* Child (birth-17)
* Adult (18-64)
* Older Adult (65+)
* All-cause mortality
A measure of all deaths, due to any cause, that occur during a clinical
study.
* Allocation
A method used to assign participants to an arm of a clinical study. The types
of allocation are randomized allocation and nonrandomized.
* 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.
* Arm type
A general description of the clinical trial arm. It identifies the role of
the intervention that participants receive. Types of arms include
experimental arm, active comparator arm, placebo comparator arm, sham
comparator arm, and no intervention arm.
* Baseline characteristics
Data collected at the beginning of a clinical study for all participants and
for each arm or comparison group. These data include demographics, such as
age, sex/gender, race and ethnicity, and study-specific measures (for
example, systolic blood pressure, prior antidepressant treatment).
* Canceled submission
Indicates that the study sponsor or investigator recalled a submission of
study results before quality control (QC) review took place. If the
submission was canceled on or after May 8, 2018, the date is shown. After
submission of study results, a study record cannot be modified until QC
review is completed, unless the submission is canceled.
* Certain agreements
Information required by the Food and Drug Administration Amendments Act of
2007. In general, this is a description of any agreement between the sponsor
of a clinical study and the principal investigator (PI) that does not allow
the PI to discuss the results of the study or publish the study results in a
scientific or academic journal after the study is completed.
* Certification
A sponsor or investigator may submit a certification to delay submission of
results information if they are applying for FDA approval of a new drug or
device, or new use of an already approved drug or device. A sponsor or
investigator who submits a certification can delay results submission up to 2
years after the certification/extension first submitted date, unless certain
events occur sooner. See Delay Results Type in the Results Data Element
definitions for more information about this certification.
* Certification/extension first posted
The date on which information about a certification to delay submission of
results or an extension request was first available on ClinicalTrials.gov.
ClinicalTrials.gov does not indicate whether the submission was a
certification or extension request. There is typically a delay between the
date the study sponsor or investigator submitted the certification or
extension request and the first posted date.
* Certification/extension first submitted
The date on which the study sponsor or investigator first submitted a
certification or an extension request to delay submission of results. A
sponsor or investigator who submits a certification can delay results
submission up to 2 years after this date, unless certain events occur sooner.
There is typically a delay between the date the certification or extension
request was submitted and the date the information is first available on
ClinicalTrials.gov (certification/extension first posted).
* Certification/extension first submitted that met QC criteria
The date on which the study sponsor or investigator first submitted a
certification or an extension request 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 certification or extension
request 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. Meeting QC criteria for an
extension request does not mean that the National Institutes of Health (NIH)
has determined that the request demonstrates good cause.
* City and distance
In the search feature, the City field is used to find clinical studies with
locations in a specific city. The Distance field is used to find studies with
locations within the specified distance from a city in number of miles. For
example, if you choose Illinois as the state, identifying "Chicago" as the
city and "100 miles" as the distance will find all studies listing a location
within 100 miles of Chicago.
* Clinical study
A research study involving human volunteers (also called participants) that
is intended to add to medical knowledge. There are two types of clinical
studies: interventional studies (also called clinical trials) and
observational studies.
* Clinical trial
Another name for an interventional study.
* ClinicalTrials.gov identifier (NCT number)
The unique identification code given to each clinical study upon registration
at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for
example, NCT00000419).
* Collaborator
An organization other than the sponsor that provides support for a clinical
study. This support may include activities related to funding, design,
implementation, data analysis, or reporting.
* Condition/disease
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.
* 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.
* Country
In the search feature, the Country field is used to find clinical studies
with locations in a specific country. For example, if you choose the United
States, you can then narrow your search by selecting a state and identifying
a city and distance.
* Cross-over assignment
A type of intervention model describing a clinical trial in which groups of
participants receive two or more interventions in a specific order. For
example, two-by-two cross-over assignment involves two groups of
participants. One group receives drug A during the initial phase of the
trial, followed by drug B during a later phase. The other group receives drug
B during the initial phase, followed by drug A. So during the trial,
participants "cross over" to the other drug. All participants receive drug A
and drug B at some point during the trial but in a different order, depending
on the group to which they are assigned.
* Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific
integrity of a clinical trial. The DMC can recommend to the sponsor that the
trial be stopped if it is not effective, is harming participants, or is
unlikely to serve its scientific purpose. Members are chosen based on the
scientific skills and knowledge needed to monitor the particular trial. Also
called a data safety and monitoring board, or DSMB.
* Early Phase 1 (formerly listed as Phase 0)
A phase of research used to describe exploratory trials conducted before
traditional phase 1 trials to investigate how or whether a drug affects the
body. They involve very limited human exposure to the drug and have no
therapeutic or diagnostic goals (for example, screening studies, microdose
studies).
* 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.
* Enrollment
The number of participants in a clinical study. The "estimated" enrollment is
the target number of participants that the researchers need for the study.
* Exclusion criteria
A type of eligibility criteria. These are reasons that a person is not
allowed to participate in a clinical study.
* 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.
For more information, see FDA Expanded Access: Information for Patients.
* Expanded access status
* 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.
* Expanded access type
Describes the category of expanded access under U.S. Food and Drug
Administration (FDA) regulations. There are three types of expanded access:
* Individual Patients: Allows a single patient, with a serious disease or
condition who cannot participate in a clinical trial, access to a drug or
biological product that has not been approved by the FDA. This category
also includes access in an emergency situation.
* Intermediate-size Population: Allows more than one patient (but generally
fewer patients than through a Treatment IND/Protocol) access to a drug or
biological product that has not been approved by the FDA. This type of
expanded access is used when multiple patients with the same disease or
condition seek access to a specific drug or biological product that has
not been approved by the FDA.
* Treatment IND/Protocol: Allows a large, widespread population access to a
drug or biological product that has not been approved by the FDA. This
type of expanded access can only be provided if the product is already
being developed for marketing for the same use as the expanded access use.
* Experimental arm
An arm type in which a group of participants receives the
intervention/treatment that is the focus of the clinical trial.
* Extension request
In certain circumstances, a sponsor or investigator may request an extension
to delay the standard results submission deadline (generally one year after
the primary completion date). The request for an extension must demonstrate
good cause (for example, the need to preserve the scientific integrity of an
ongoing masked trial). All requests must be reviewed and granted by the
National Institutes of Health. See Delay Results Type in the Results Data
Element definitions for more information.
* Factorial assignment
A type of intervention model describing a clinical trial in which groups of
participants receive one of several combinations of interventions. For
example, two-by-two factorial assignment involves four groups of
participants. Each group receives one of the following pairs of
interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo
and drug B, or (4) a placebo and a placebo. So during the trial, all possible
combinations of the two drugs (A and B) and the placebos are given to
different groups of participants.
* FDAAA 801 Violations
A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug
Administration (FDA) has issued a Notice of Noncompliance to the responsible
party of an applicable clinical trial. A Notice of Noncompliance indicates
that the FDA has determined the responsible party was not in compliance with
the registration or results reporting requirements for the clinical trial
under the Food and Drug Administration Amendments Act of 2007, Section 801
(FDAAA 801).
The National Library of Medicine (NLM) is required by FDAAA 801 to add
information to a study record about any FDAAA 801 Violation. This information
is provided by the FDA. There are three categories of information that may be
included:
* Violation: Shown when the FDA issues a Notice of Noncompliance and posts
the Notice of Noncompliance on its designated webpage. There are three
types of violations:
* Failure to submit required clinical trial information
* Submission of false or misleading clinical trial information
* Failure to submit primary and secondary outcomes
* Correction: Shown when the FDA confirms that the responsible party has
updated the study record to correct the violation and posts the correction
notice on its designated webpage. Because of the time for FDA review and
processing, there may be a delay between the date when the study record
was updated and the addition of correction information to the FDAAA 801
Violation information.
* Penalty: Shown when the FDA imposes a penalty for the violation and posts
the penalty notice on its designated webpage.
* 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.
* 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).
* 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.
* Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801
of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand
ClinicalTrials.gov and create a clinical study results database. For more
information on FDAAA 801, see the History, Policies, and Laws page on this
site.
* Funder type
Describes the organization that provides funding or support for a clinical
study. This support may include activities related to funding, design,
implementation, data analysis, or reporting. Organizations listed as sponsors
and collaborators for a study are considered the funders of the study.
ClinicalTrials.gov refers to four types of funders:
* U.S. National Institutes of Health
* Other U.S. Federal agencies (for example, Food and Drug Administration,
Centers for Disease Control and Prevention, or U.S. Department of Veterans
Affairs)
* Industry (for example: pharmaceutical and device companies)
* All others (including individuals, universities, and community-based
organizations)
* Gender-based eligibility
A type of eligibility criteria that indicates whether eligibility to
participate in a clinical study is based a person's self-representation of
gender identity or gender (yes, no). Gender is distinct from sex.
* Group/cohort
A group or subgroup of participants in an observational study that is
assessed for biomedical or health outcomes.
* Human subjects protection review board
A group of people who review, approve, and monitor the clinical study's
protocol. Their role is to protect the rights and welfare of people
participating in a study (referred to as human research subjects), such as
reviewing the informed consent form. The group typically includes people with
varying backgrounds, including a community member, to make sure that research
activities conducted by an organization are completely and adequately
reviewed. Also called an institutional review board, or IRB, or an ethics
committee.
For more information, see Participating in Studies on this site.
* Inclusion criteria
A type of eligibility criteria. These are the reasons that a person is
allowed to participate in a clinical study.
* Informed consent
A process used by researchers to communicate to potential and enrolled
participants the risks and potential benefits of participating in a clinical
study.
For more information, see Participating in Studies on this site.
* Informed consent form (ICF)
The document used in the informed consent or process.
* Intervention model
The general design of the strategy for assigning interventions to
participants in a clinical study. Types of intervention models include:
single group assignment, parallel assignment, cross-over assignment, and
factorial assignment.
* 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.
* Interventional study (clinical trial)
A type of clinical study in which participants are assigned to groups that
receive one or more intervention/treatment (or no intervention) so that
researchers can evaluate the effects of the interventions on biomedical or
health-related outcomes. The assignments are determined by the study's
protocol. Participants may receive diagnostic, therapeutic, or other types of
interventions.
* Investigator
A researcher involved in a clinical study. Related terms include site
principal investigator, site sub-investigator, study chair, study director,
and study principal investigator.
* 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.
* Last update submitted
The most recent date on which the study sponsor or investigator submitted
changes to a study record to ClinicalTrials.gov. There is typically a delay
of a few days between the last update submitted date and when the date
changes are posted on ClinicalTrials.gov (the last update posted date).
* 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.
* 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.
* Listed location countries
Countries in which research facilities for a study are located. A country is
listed only once, even if there is more than one facility in the country. The
list includes all countries as of the last update submitted date; any country
for which all facilities were removed from the study record are listed under
removed location countries.
* Location terms
In the search feature, the Location terms field is used to narrow a search by
location-related terms other than Country, State, and City or distance. For
example, you may enter a specific facility name (such as National Institutes
of Health Clinical Center) or a part of a facility name (such as Veteran for
studies listing Veterans Hospital or Veteran Affairs in the facility name).
Note: Not all study records include this level of detail about locations.
* Masking
A clinical trial design strategy in which one or more parties involved in the
trial, such as the investigator or participants, do not know which
participants have been assigned which interventions. Types of masking
include: open label, single blind masking, and double-blind masking.
* NCT number
A unique identification code given to each clinical study record registered
on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for
example, NCT00000419). Also called the ClinicalTrials.gov identifier.
* No intervention arm
An arm type in which a group of participants does not receive any
intervention/treatment during the clinical trial.
* Observational study
A type of clinical study in which participants are identified as belonging to
study groups and are assessed for biomedical or health outcomes. Participants
may receive diagnostic, therapeutic, or other types of interventions, but the
investigator does not assign participants to a specific
interventions/treatment.
A patient registry is a type of observational study.
* Observational study model
The general design of the strategy for identifying and following up with
participants during an observational study. Types of observational study
models include cohort, case-control, case-only, case-cross-over, ecologic or
community studies, family-based, and other.
* Other adverse event
An adverse event that is not a serious adverse event, meaning that it does
not result in death, is not life-threatening, does not require inpatient
hospitalization or extend a current hospital stay, does not result in an
ongoing or significant incapacity or interfere substantially with normal life
functions, and does not cause a congenital anomaly or birth defect; it also
does not put the participant in danger and does not require medical or
surgical intervention to prevent one of the results listed above.
* Other study IDs
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.
* Other terms
In the search feature, the Other terms field is used to narrow a search. For
example, you may enter the name of a drug or the NCT number of a clinical
study to limit the search to study records that contain these words.
* Outcome measure
For clinical trials, a planned measurement described in the protocol that is
used to determine the effect of an intervention/treatment on participants.
For observational studies, a measurement or observation that is used to
describe patterns of diseases or traits, or associations with exposures, risk
factors, or treatment. Types of outcome measures include primary outcome
measure and secondary outcome measure.
* Parallel assignment
A type of intervention model describing a clinical trial in which two or more
groups of participants receive different interventions. For example, a
two-arm parallel assignment involves two groups of participants. One group
receives drug A, and the other group receives drug B. So during the trial,
participants in one group receive drug A "in parallel" to participants in the
other group, who receive drug B.
* Participant flow
A summary of the progress of participants through each stage of a clinical
study, by study arm or group/cohort. This includes the number of participants
who started, completed, and dropped out of the study.
* Patient registry
A type of observational study that collects information about patients'
medical conditions and/or treatments to better understand how a condition or
treatment affects patients in the real world.
* 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 1
A phase of research to describe clinical trials that focus on the safety of a
drug. They are usually conducted with healthy volunteers, and the goal is to
determine the drug's most frequent and serious adverse events and, often, how
the drug is broken down and excreted by the body. These trials usually
involve a small number of participants.
* Phase 2
A phase of research to describe clinical trials that gather preliminary data
on whether a drug works in people who have a certain condition/disease (that
is, the drug's effectiveness). For example, participants receiving the drug
may be compared to similar participants receiving a different treatment,
usually an inactive substance (called a placebo) or a different drug. Safety
continues to be evaluated, and short-term adverse events are studied.
* Phase 3
A phase of research to describe clinical trials that gather more information
about a drug's safety and effectiveness by studying different populations and
different dosages and by using the drug in combination with other drugs.
These studies typically involve more participants.
* Phase 4
A phase of research to describe clinical trials occurring after FDA has
approved a drug for marketing. They include postmarket requirement and
commitment studies that are required of or agreed to by the study sponsor.
These trials gather additional information about a drug's safety, efficacy,
or optimal use.
* Phase Not Applicable
Describes trials without FDA-defined phases, including trials of devices or
behavioral interventions.
* Placebo
An inactive substance or treatment that looks the same as, and is given in
the same way as, an active drug or intervention/treatment being studied.
* Placebo comparator arm
An arm type in which a group of participants receives a placebo during a
clinical trial.
* Primary completion date
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 "estimated" primary completion date is the date that the
researchers think will be the primary completion date for the study.
* Primary outcome measure
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.
* Primary purpose
The main reason for the clinical trial. The types of primary purpose are:
treatment, prevention, diagnostic, supportive care, screening, health
services research, basic science, and other.
* Principal investigator (PI)
The person who is responsible for the scientific and technical direction of
the entire clinical study.
* Protocol
The written description of a clinical study. It includes the study's
objectives, design, and methods. It may also include relevant scientific
background and statistical information.
* Quality control (QC) review
National Library of Medicine (NLM) staff perform a limited review of
submitted study records for apparent errors, deficiencies, or
inconsistencies. NLM staff identify potential major and advisory issues and
provide comments directly to the study sponsor or investigator. Major issues
identified in QC review must be addressed or corrected (see First submitted
that met QC criteria and Results first submitted that met QC criteria).
Advisory issues are suggestions to help improve the clarity of the record.
NLM staff do not verify the scientific validity or relevance of the submitted
information. The study sponsor or investigator is responsible for ensuring
that the studies follow all applicable laws and regulations.
* Randomized allocation
A type of allocation strategy in which participants are assigned to the arms
of a clinical trial by chance.
* Recruitment status
* Not yet recruiting: The study has not started recruiting participants.
* Recruiting: The study is currently recruiting participants.
* Enrolling by invitation: The study is selecting its participants from a
population, or group of people, decided on by the researchers in advance.
These studies are not open to everyone who meets the eligibility criteria
but only to people in that particular population, who are specifically
invited to participate.
* Active, not recruiting: The study is ongoing, and participants are
receiving an intervention or being examined, but potential participants
are not currently being recruited or enrolled.
* Suspended: The study has stopped early but may start again.
* Terminated: The study has stopped early and will not start again.
Participants are no longer being examined or treated.
* Completed: The study has ended normally, and participants are no longer
being examined or treated (that is, the last participant's last visit has
occurred).
* Withdrawn: The study stopped early, before enrolling its first
participant.
* Unknown: A study on ClinicalTrials.gov whose last known status was
recruiting; not yet recruiting; or active, not recruiting but that has
passed its completion date, and the status has not been last verified
within the past 2 years.
* Registration
The process of submitting and updating summary information about a clinical
study and its protocol, from its beginning to end, to a structured, public
Web-based study registry that is accessible to the public, such as
ClinicalTrials.gov.
* Removed location countries
Countries that appeared under listed location countries but were removed from
the study record by the sponsor or investigator.
* Reporting group
A grouping of participants in a clinical study that is used for summarizing
the data collected during the study. This grouping may be the same as or
different from a study arm or group.
* Responsible party
The person responsible for submitting information about a clinical study to
ClinicalTrials.gov and updating that information. Usually the study sponsor
or investigator.
* Results database
A structured online system, such as the ClinicalTrials.gov results database,
that provides the public with access to registration and summary results
information for completed or terminated clinical studies. A study with
results available on ClinicalTrials.gov is described as having the results
"posted."
Note: The ClinicalTrials.gov results database became available in September
2008. Older studies are unlikely to have results available in the database.
* Results delayed
Indicates that the sponsor or investigator submitted a certification or
extension request.
* Results first posted
The date on which summary results information was first available on
ClinicalTrials.gov after National Library of Medicine (NLM) quality control
(QC) review has concluded. There is typically a delay between the date the
study sponsor or investigator first submits summary results information (the
results first submitted date) and the results first posted date. Some results
information may be available at an earlier date if Results First Posted with
QC Comments.
* Results first posted with QC comments
The date on which summary results information was first available on
ClinicalTrials.gov with quality control review comments from the National
Library of Medicine (NLM) identifying major issues that must be addressed by
the sponsor or investigator. As of January 1, 2020, initial results
submissions for applicable clinical trials (ACTs) that do not meet quality
control review criteria will be publicly posted on ClinicalTrials.gov with
brief standardized major comments. Accordingly, the Results First Posted with
QC Comments date may be earlier than the Results First Posted date for an ACT
with summary results information that is not consistent with NLM quality
control review criteria.
* Results first submitted
The date on which the study sponsor or investigator first submits a study
record with summary results information. There is typically a delay between
the results first submitted date and when summary results information becomes
available on ClinicalTrials.gov (the results first posted date).
* Results first submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study
record with summary results information that is consistent with National
Library of Medicine (NLM) quality control (QC) review criteria. The sponsor
or investigator may need to revise and submit results information 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.
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DLL3-DIRECTED CHIMERIC ANTIGEN RECEPTOR T-CELLS IN SUBJECTS WITH EXTENSIVE STAGE
SMALL CELL LUNG CANCER
The safety and scientific validity of this study is the responsibility of the
study sponsor and investigators. Listing a study does not mean it has been
evaluated by the U.S. Federal Government. Know the risks and potential benefits
of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05680922
Recruitment Status : Recruiting
First Posted : January 11, 2023
Last Update Posted : October 17, 2023
See Contacts and Locations
View this study on the modernized ClinicalTrials.gov
Sponsor:
Legend Biotech USA Inc
Information provided by (Responsible Party):
Legend Biotech USA Inc
* Study Details
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Study Description
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Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a phase 1, first-in-human, open-label, multicenter, dose escalation and
expansion study of DLL3-targeted chimeric antigen receptor T-cells in subjects
with extensive stage small cell lung cancer or large cell neuroendocrine lung
cancer.
Condition or disease Intervention/treatment Phase Small Cell Lung Cancer
Extensive Stage Large Cell Neuroendocrine Carcinoma of the Lung Biological:
LB2102 Phase 1
Detailed Description:
This is a phase 1, first-in-human, open-label, multicenter, dose escalation and
expansion study of DLL3-targeted chimeric antigen receptor T-cells in subjects
with extensive stage small cell lung cancer or large cell neuroendocrine lung
cancer. The study comprises a dose-escalation component (Part A) and a cohort
expansion component (Part B). Up to 41 subjects will be treated in this study.
Part A will enroll and treat up to 24 subjects and Part B will be conducted
after the recommended dose for expansion (RDE) has been identified in Part A and
enroll up to 17 subjects. Both parts of this trial will include a Screening
Period, a Pretreatment Period, a Treatment Period, a Follow-Up Period, and a
Post-Progression Follow-Up Period.
Study Design
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Measures Eligibility Criteria Contacts and Locations More Information
Layout table for study information Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 41 participants Allocation: N/A Intervention Model:
Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title: A First in Human Dose Escalation and Cohort Expansion Study of
DLL3-directed Chimeric Antigen Receptor T-cells in Subjects With Extensive Stage
Small Cell Lung Cancer Actual Study Start Date : July 26, 2023 Estimated Primary
Completion Date : January 2028 Estimated Study Completion Date : March 2028
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics: Lung cancer
MedlinePlus related topics: Lung Cancer
Genetic and Rare Diseases Information Center resources: Small Cell Lung Cancer
Neuroendocrine Tumor Neuroepithelioma
U.S. FDA Resources
Arms and Interventions
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Measures Eligibility Criteria Contacts and Locations More Information
Arm Intervention/treatment Experimental: Experimental LB2102
DLL3-Directed Chimeric Antigen Receptor T-cells (CAR T)
Biological: LB2102
DLL3 directed autologous Chimeric Antigen Receptor T-cells
Outcome Measures
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Measures Eligibility Criteria Contacts and Locations More Information
Primary Outcome Measures :
1. To characterize the safety and tolerability of LB2102 and determine
recommended dose for expansion (RDE) [ Time Frame: 28 days ]
Multiple doses will be tested to establish a recommended dose
2. To further characterize the safety and tolerability of LB2102 with the RDE
identified in the dose-escalation and determine the recommended Phase 2 dose
(RP2D) [ Time Frame: 90 days ]
Treatment of additional patients at the recommended dose as identified in
the initial dose escalation part of the study
Secondary Outcome Measures :
1. To evaluate the preliminary efficacy of LB2102 [ Time Frame: Through study
completion, a minimum of 2 years ]
Measured by Response Evaluation Criteria In Solid Tumors (RECIST)
2. To characterize the pharmacokinetics of LB2102 in blood
[ Time Frame: Through study completion, a minimum of 2 years ]
CAR-positive T cell counts in cells/microliter (μL) blood
3. To evaluate the immunogenicity of LB2102 [ Time Frame: Through study
completion, a minimum of 2 years ]
Number of subjects with presence of anti-LB2102 antibodies
Eligibility Criteria
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Measures Eligibility Criteria Contacts and Locations More Information
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with
your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the contacts provided below. For general information, Learn About
Clinical Studies.
Layout table for eligibility information Ages Eligible for Study: 18 Years and
older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy
Volunteers: No
Criteria
Inclusion Criteria:
* Be at least 18 years of age and willing and able to provide a written
informed consent
* Have histologically/cytologically confirmed unresectable small cell lung
carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), combined
SCLC, or combined LCNEC as per WHO 2021 criteria
* Subjects who have at least one prior line of standard treatment, and have
progressed after or have had an insufficient response, and for whom standard
treatment is intolerable, unlikely to confer significant clinical benefit, is
no longer effective, or the subject declines further standard treatment
* Have available formalin-fixed, paraffin-embedded tumor specimen in a tissue
block or unstained serial slides accompanied by an associated pathology
report prior to enrollment. Archival or fresh biopsy tissue is required
* Presence of ≥ 1 radiologically measurable lesion per Response Evaluation
Criteria In Solid Tumors (RECIST) Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 4 months
* Have adequate organ function
* Women of childbearing potential must have a negative pregnancy test at
screening using a highly sensitive serum pregnancy test (β-human chorionic
gonadotropin [β-hCG])
* All subjects must agree to practice a highly effective method of
contraception (failure rate of <1% per year when used consistently and
correctly) from the time of signing the informed consent form (ICF) to 1 year
after receiving a LB2102 infusion
* Women and men must agree not to donate eggs (ova, oocytes) or sperm,
respectively, until at least 1 year after receiving a LB2102 infusion
* Must have adequate leukapheresis material of non-mobilized cells available
for manufacturing
Exclusion Criteria:
* Prior treatment with cellular immunotherapy (e.g., CAR-T) or gene therapy
product
* Prior treatment with DLL3-targeted therapy
* Prior history of checkpoint inhibitor associated pneumonitis
* Clinically significant ascites, pleural or peritoneal effusions
* Primary acquired or inherited immunodeficiency syndromes
* Known leptomeningeal metastases
* Active or symptomatic brain metastasis. Subjects with treated brain
metastasis are eligible provided additional requirements are met per
protocol.
* Active autoimmune disease receiving immunomodulatory treatments (e.g.,
cyclosporine or high dose systemic steroids)
* Impaired cardiac function or clinically significant cardiac disease not
controlled by medications
* Previous or concurrent malignancy, excluding certain exceptions
* Serious and /or uncontrolled medical condition that, in the Investigator's
judgment, would cause unacceptable safety risk, interfere with study
procedures or results, or compromise compliance with the protocol
* Subjects with known active infection with HIV, hepatitis B, and/or hepatitis
C virus (HBV/HCV) are not eligible unless additional protocol requirements
are met.
* Contraindications or life-threatening allergies, hypersensitivity, or
intolerance to LB2102 excipients, such as dimethyl sulfoxide; or to
fludarabine, cyclophosphamide, or tocilizumab
* Ongoing toxicity of organ functions from previous anticancer therapy that has
not resolved to Grade 1 or less, except for alopecia
* Major surgery within 4 weeks prior to apheresis, or planned within 4 weeks
after LB2102 administration
* Pregnant or breast-feeding
* Plans to become pregnant or breastfeed, or father a child within 1 year after
receiving a LB2102 infusion
* Previous history of allogeneic hematopoietic stem cell transplantation
(HSCT), organ transplant, or in preparation for organ transplant
Contacts and Locations
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Measures Eligibility Criteria Contacts and Locations More Information
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study
research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number):
NCT05680922
Contacts
Layout table for location contacts Contact: Legend Biotech USA 17323175050
medical.information@legendbiotech.com
Locations
Layout table for location information United States, Florida Moffitt Cancer
Center Recruiting Tampa, Florida, United States, 33612 Contact: Tina
Swartzlander 813-745-5517 Tina.Swartzlander@moffitt.org Principal
Investigator: Alberto Chiappori, MD United States, Kentucky University
of Kentucky - Markey Cancer Center Recruiting Lexington, Kentucky, United
States, 40536 Contact: Zhonglin Hao, MD Contact: Heather L Heath
heather.flynn@uky.edu Principal Investigator: Zhonglin Hao, MD
United States, Massachusetts Dana-Farber Cancer Institute Recruiting Boston,
Massachusetts, United States, 02215 Contact: Hope Wei, BA 617-632-3486
HopeY_Wei@DFCI.HARVARD.EDU Contact: Jordan Weiss, BA 617-632-4582
jacob_sands@dfci.harvard.edu Principal Investigator: Jacob Sands, MD
United States, New York Memorial Sloan Kettering Cancer Center Not yet
recruiting New York, New York, United States, 10017 Contact: Adam Schoenfeld, MD
Sponsors and Collaborators
Legend Biotech USA Inc
More Information
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Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information Responsible Party: Legend Biotech USA Inc
ClinicalTrials.gov Identifier: NCT05680922 History of Changes Other Study ID
Numbers: LB2102-1001
First Posted: January 11, 2023 Key Record Dates Last Update Posted: October
17, 2023 Last Verified: October 2023
Layout table for additional information Studies a U.S. FDA-regulated Drug
Product: Yes Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
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