Lung CancerNCT03047616
A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
An observational study of Lung Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood and Urine Collection
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to 31 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adults with non-small cell lung cancer (NSCLC)
Who may be able to join
- Advanced Metastatic NSCLC
- Scheduled to initiate an immune checkpoint inhibitor
- Age >= 18 years
- Able to provide informed consent
Who cannot join
- Other, unrelated, concomitant active, invasive malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.
- Conditions
- Lung Cancer
- Being tested
- Blood and Urine Collection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and Urine CollectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between markers identified in the blood and in the primary tumor.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start22 Nov 2016
- Primary completion1 Jan 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charu Aggarwal, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047616
- Sponsor's protocol ID
- 27516
- Status last verified
- Apr 2021
- First submitted
- 6 Feb 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aggarwal C, Thompson JC, Chien AL, Quinn KJ, Hwang WT, Black TA, Yee SS, Christensen TE, LaRiviere MJ, Silva BA, Banks KC, Nagy RJ, Helman E, Berman AT, Ciunci CA, Singh AP, Wasser JS, Bauml JM, Langer CJ, Cohen RB, Carpenter EL. Baseline Plasma Tumor Mutation Burden Predicts Response to Pembrolizumab-based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 May 15;26(10):2354-2361. doi: 10.1158/1078-0432.CCR-19-3663. Epub 2020 Feb 26.
PubMed 32102950
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Develop Predictive Biomarkers for the Response to Immunotherapy in Lung Cancer
- ClinicalTrials.gov ID
- NCT03047616
- Acronym / sponsor ID
- 27516
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Several immune checkpoint inhibitors targeting the PD-1 pathway have been developed with clinical trials showing an approximately 20% durable response in unselected patients with advanced non-small cell lung cancer (NSCLC). At the moment, no clear biomarker exists to accurately predict anti-PD1/PDL1 tumor responsiveness. The goal of this study is to broadly discover and evaluate the utility of blood based biomarkers for use in measuring and predicting response to immunotherapy in patients with lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with non-small cell lung cancer (NSCLC)
Key inclusion criteria (4 listed)
- Advanced Metastatic NSCLC
- Scheduled to initiate an immune checkpoint inhibitor
- Age >= 18 years
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Other, unrelated, concomitant active, invasive malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and Urine Collection | Other | – |
Primary outcome
the correlation between markers identified in the blood and in the primary tumor.
Time frame: 5 years
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 19 Apr 2021.
- Derived from this study: PubMed 32102950Aggarwal C, Thompson JC, Chien AL, Quinn KJ, Hwang WT, Black TA, Yee SS, Christensen TE, LaRiviere MJ, Silva BA, Banks KC, Nagy RJ, Helman E, Berman AT, Ciunci CA, Singh AP, Wasser JS, Bauml JM, Langer CJ, Cohen RB, Carpenter EL. Baseline Plasma Tumor Mutation Burden Predicts Response to Pembrolizumab-based Therapy in Patients with Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 May 15;26(10):2354-2361. doi: 10.1158/1078-0432.CCR-19-3663. Epub 2020 Feb 26.
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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.
Charu Aggarwal, MD principal investigator
Abramson Cancer Center at Penn Medicine
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 Lung Cancer, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 1 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 19 Apr 2021. 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?
the correlation between markers identified in the blood and in the primary tumor. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047616, which also lists 1 linked publication.
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 19 Apr 2021.