Non Small Cell Lung CancerNCT04187768
Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, run by Indiana University at 1 site in United States.
Trial summary
This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Healthy
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 13 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced NSCLC and healthy volunteers with no diagnosis of cancer, known immunodeficiency or other serious chronic illness
Who may be able to join
- ≥ 18 years old at the time of informed consent
- Written informed consent and HIPAA authorization for release of personal health information.
- Subjects with histologically and radiographically confirmed NSCLC.
- Subjects must have stage IV disease or recurrent disease.
- Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.
- Subjects who are eligible to receive single agent immunotherapy must have documentation of a PD-L1 Tumor Proportion Score (TPS) of at least 1%.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Who cannot join
- Subjects with curable or potentially curable NSCLC.
- Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.
- Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.
- Subjects eligible for combination treatment with chemoimmunotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy
This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer
- Keywords
- Blood Donation, Lung Cancer, Non Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
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 |
|---|---|---|
| Healthy Group | Healthy volunteers will donate a sample of blood to be used as controls | |
| NSCLC Group | Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in myeloid derived suppressive cells (MDSCs)
change in MDSCs before and after treatment
Measured: baseline and cycle 3
Mean change in B regulatory cells (Bregs)
change in Bregs before and after treatment
Measured: baseline and cycle 3
Mean change in T regulatory cells (Tregs) before and after treatment
change in Tregs before and after treatment
Measured: baseline and cycle 3
Secondary outcomes (2)
Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
Measured: baseline, cycle 3
Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
Measured: baseline, cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start26 Nov 2019
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Hanna, Indiana University
- Investigators
- Nasser Hanna, MD, Principal investigator, Indiana Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187768
- Sponsor's protocol ID
- CTO-IUSCC-0701
- Status last verified
- Jul 2022
- First submitted
- 3 Dec 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Profile Changes In Patients With Advanced Non-Small Cell Lung Cancer Undergoing Treatment With Checkpoint Inhibitor Monotherapy
- ClinicalTrials.gov ID
- NCT04187768
- Acronym / sponsor ID
- CTO-IUSCC-0701
- Keywords
- Blood Donation, Lung Cancer, Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 5 Dec 2019 (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.
This is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. Blood will be collected from healthy volunteers and patients with non small cell lung cancer
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | –Healthy volunteers will donate a sample of blood to be used as controls |
| NSCLC Group | – | –Patients with advanced NSCLC will have blood collected prior to treatment and after completing 3 cycles of immune checkpoint therapy. . If a patient is noted to have progressive disease after 2 cycles of treatment, a sample will be collected after the 2nd cycle. If a patient is noted to have pseudoprogression (determined at the discretion of the treating physician), an additional sample may be collected after 3 cycles of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced NSCLC and healthy volunteers with no diagnosis of cancer, known immunodeficiency or other serious chronic illness
Key inclusion criteria (7 listed)
- ≥ 18 years old at the time of informed consent
- Written informed consent and HIPAA authorization for release of personal health information.
- Subjects with histologically and radiographically confirmed NSCLC.
- Subjects must have stage IV disease or recurrent disease.
- Subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. Prior radiation or surgery is permissible.
Key exclusion criteria (4 listed)
- Subjects with curable or potentially curable NSCLC.
- Subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria.
- Patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy.
- Subjects eligible for combination treatment with chemoimmunotherapy.
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
Mean change in myeloid derived suppressive cells (MDSCs)
Time frame: baseline and cycle 3
change in MDSCs before and after treatment
Mean change in B regulatory cells (Bregs)
Time frame: baseline and cycle 3
change in Bregs before and after treatment
Mean change in T regulatory cells (Tregs) before and after treatment
Time frame: baseline and cycle 3
change in Tregs before and after treatment
2 secondary outcomes
Describe the programmed death-ligand 1 (PD-L1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
Time frame: baseline, cycle 3
Describe the programmed death-ligand 1 (PD1) expression profile on peripheral blood MDSCs, Bregs, and Tregs
Time frame: baseline, cycle 3
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 20 Jul 2022.
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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.
Nasser Hanna, MD principal investigator
Indiana Unversity
1 site in 1 country: 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 and Non Small Cell Lung Cancer Metastatic, run by Indiana University at 1 site in United States.
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 7 inclusion and 4 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Mean change in myeloid derived suppressive cells (MDSCs) (time frame: baseline and cycle 3). The study lists 3 primary outcomes in all. 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 20 Jul 2022.