Non-Small Cell Lung CancerNCT03389399
Pulmonary Physiology and Systemic Inflammatory in EO Pulmonary Events With Brigatinib Use in NSCLC and Other Diseases
An observational study of Non-Small Cell Lung Cancer, run by University of Colorado, Denver at 5 sites in 2 countries.
Trial summary
To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib at 90mg QD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 18 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Feb 2018to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational study. Brigatinib is not administered by this study. Instead, participants will receive brigatinib as part of an ongoing thereapeutic clinical trial or will be prescribed brigatinib, which is now an FDA-approved drug. Entry criteria for this study will focus on those suitable for this observational study. Any brigatinib-related safety procedure or follow-up will also be set forth by the FDA label or the relevant clinical trial that is administering brigatinib to the participant in this study.
Who may be able to join
- Provision to sign and date the consent form, indicating that he or she has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
- Stated willingness and ability to comply with all scheduled visits and study procedures, and be available for the duration of the study.
- Be a male or female aged ≥ 18.
- Must plan on receiving brigatinib at a starting dose of 90 mg QD, regardless of whether they are receiving brigatinib as a part of clinical trial (if they meet eligibility criteria for given clinical trial) or outside of clinical trial as part of standard of care cancer treatment per the FDA license.
- Suitable for treatment with brigatinib per either FDA labels, an acceptable clinical indication or within brigatinib clinical trials.
- Participants must plan on taking Brigatinib as the only systemic cancer treatment. This means that participants cannot be receiving other targeted therapies, chemotherapies, or immunotherapies while on brigatinib (Exceptions: nonimmunosuppressive supportive cancer therapies such as bone targeting agents [e.g., denosumab], and anti-emetics are allowed).
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- Must have Hemoglobin (Hb) of ≥10 g/dL.
- Recovered from clinically relevant toxicities (in the opinion of the investigator) related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.03) grade ≤2.
- Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Must have clearly documented information of previously received systemic cancer treatments including chemotherapy, immunotherapy, small molecule tyrosine-kinase inhibitors (incl. ALK-targeted TKI) and stop date of most recent systemic therapy.
Who cannot join
- Have baseline oxygen supplementation requirement (i.e., resting O2 sats on room air ≥ 90%).
- Have history or presence of pulmonary interstitial disease or drug-related pneumonitis on CT imaging of chest performed within 28 days prior to starting brigatinib.
- Have malabsorption syndrome or other GI illness that could affect oral absorption of the study drug in the opinion of the investigator.
- Have had a blood transfusion within past 120 days.
- Have received any small molecule inhibitors, including crizotinib, within 7 days of the first dose of Brigatinib (e.g., If first scheduled dose of brigatinib is on a Monday, May 1st, 2017 then last dose of the prior line of small molecule inhibitor must have been given BEFORE Monday, April 24, 2017).
- Have received cytotoxic chemotherapy, investigational agents, or cytotoxic doses of radiation within 14 days of brigatinib, except SRS or stereotactic body radiosurgery to anatomic sites not involving lung tissue.
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- Have received immunotherapy within 28 days of first dose of brigatinib.
- Be on corticosteroid within 48 hours prior to first dose of brigatinib.
- Have uncontrolled, or active cardiac, pulmonary or hematologic disease that can affect interpretation of DLCO, specifically including, but not restricted to:
- Pulmonary interstitial disease or drug-related pneumonitis
- Symptomatic or poorly controlled congestive heart failure (CHF) within 6 months prior to first dose
- Symptomatic or poorly controlled pulmonary embolism within last 6 months
- Have an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.
- Have a known or suspected hypersensitivity to AP26113 or its excipients.
- Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation of the drug study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Colorado Denver
Aurora, Colorado, 80045
UT Southwestern Harold C Simmons Comprehensive Cancer Center
Dallas, Texas, 75390
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Pulmonary Physiology and Systemic Inflammatory Signature Investigations in Early Onset Pulmonary Events Associated With Brigatinib Use in Non-Small Cell Lung Cancer and Other Diseases
To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib at 90mg QD.
Read the detailed description
This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Participants who enroll on this study protocol will either be taking brigatinib in the context of an ongoing clinical trial, or as part of standard of care treatment as licensed by FDA.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Brigatinib, Early Onset Pulmonary Events
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days | This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Study procedures include PFTs, 6minute walk test, Modified Borg dyspnea scale (mBDS), and phlebotomy before participants commence brigatinib and on days 2 and 8 of brigatinib treatment. Participants that develop a peak reduction in DLCO of 20% or more from baseline whose DLCO does not return to their baseline level on day 8 may, at the discretion of the investigator, undergo repeated testing on a subsequent time point (e.g., day 15) for serial observation to ensure resolution of EOPE if that is the suspected cause of DLCO reduction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the incidence of Early Onset Pulmonary Events (EOPEs)
EOPEs is defined as the proportion of participants with a peak reduction in Diffusion capacity in the Lung of Carbon monoxide (DLCO) of 20% or greater after commencing brigatinib at 90mg once daily QD.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start22 Feb 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Criterium, Inc.
- Responsible party
- Sponsor
- Investigators
- Camidge Ross, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389399
- Sponsor's protocol ID
- 17-0846.cc
- Status last verified
- Mar 2025
- First submitted
- 27 Dec 2017
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Physiology and Systemic Inflammatory Signature Investigations in Early Onset Pulmonary Events Associated With Brigatinib Use in Non-Small Cell Lung Cancer and Other Diseases
- ClinicalTrials.gov ID
- NCT03389399
- Acronym / sponsor ID
- 17-0846.cc
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Brigatinib, Early Onset Pulmonary Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Criterium, Inc.
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the incidence of Early Onset Pulmonary Events (EOPEs), defined as the proportion of participants with a peak reduction in DLCO of 20% or greater after commencing brigatinib at 90mg QD.
Detailed description
This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Participants who enroll on this study protocol will either be taking brigatinib in the context of an ongoing clinical trial, or as part of standard of care treatment as licensed by FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days | – | –This is a single-arm study of patients who plan on starting brigatinib 90 mg QD or brigatinib 90 mg QD x 7 days to brigatinib 180 mg QD. Study procedures include PFTs, 6minute walk test, Modified Borg dyspnea scale (mBDS), and phlebotomy before participants commence brigatinib and on days 2 and 8 of brigatinib treatment. Participants that develop a peak reduction in DLCO of 20% or more from baseline whose DLCO does not return to their baseline level on day 8 may, at the discretion of the investigator, undergo repeated testing on a subsequent time point (e.g., day 15) for serial observation to ensure resolution of EOPE if that is the suspected cause of DLCO reduction. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study. Brigatinib is not administered by this study. Instead, participants will receive brigatinib as part of an ongoing thereapeutic clinical trial or will be prescribed brigatinib, which is now an FDA-approved drug. Entry criteria for this study will focus on those suitable for this observational study. Any brigatinib-related safety procedure or follow-up will also be set forth by the FDA label or the relevant clinical trial that is administering brigatinib to the participant in this study.
Key inclusion criteria (10 listed)
- Provision to sign and date the consent form, indicating that he or she has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
- Stated willingness and ability to comply with all scheduled visits and study procedures, and be available for the duration of the study.
- Be a male or female aged ≥ 18.
- Must plan on receiving brigatinib at a starting dose of 90 mg QD, regardless of whether they are receiving brigatinib as a part of clinical trial (if they meet eligibility criteria for given clinical trial) or outside of clinical trial as part of standard of care cancer treatment per the FDA license.
- Suitable for treatment with brigatinib per either FDA labels, an acceptable clinical indication or within brigatinib clinical trials.
Key exclusion criteria (15 listed)
- Have baseline oxygen supplementation requirement (i.e., resting O2 sats on room air ≥ 90%).
- Have history or presence of pulmonary interstitial disease or drug-related pneumonitis on CT imaging of chest performed within 28 days prior to starting brigatinib.
- Have malabsorption syndrome or other GI illness that could affect oral absorption of the study drug in the opinion of the investigator.
- Have had a blood transfusion within past 120 days.
- Have received any small molecule inhibitors, including crizotinib, within 7 days of the first dose of Brigatinib (e.g., If first scheduled dose of brigatinib is on a Monday, May 1st, 2017 then last dose of the prior line of small molecule inhibitor must have been given BEFORE Monday, April 24, 2017).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the incidence of Early Onset Pulmonary Events (EOPEs)
Time frame: 8 days
EOPEs is defined as the proportion of participants with a peak reduction in Diffusion capacity in the Lung of Carbon monoxide (DLCO) of 20% or greater after commencing brigatinib at 90mg once daily QD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camidge Ross, MD principal investigator
University of Colorado, Denver
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by University of Colorado, Denver at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the incidence of Early Onset Pulmonary Events (EOPEs) (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.