Non Small Cell Lung CancerNCT03877250
Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
An observational study of Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Pre-Treatment Biopsy, On-Treatment Biopsy and Biopsy at Disease Progression
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Mar 2019to 26 Aug 2020
- 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: Participants with newly diagnosed or recurrent, PD-L1 high (>50%) metastatic non-small cell lung cancer without prior PD-(L)1 therapy
Who may be able to join
- Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 >/= 50%)
- Intended treatment with a PD-(L)1 inhibitor
- Age >/= 18 years
- Karnofsky Performance Status >/= 70% and medically fit to undergo a biopsy procedure
Who cannot join
- Any medical condition or any sites of disease that would preclude a biopsy
- Pregnant or breastfeeding women
- Cognitively impairment affecting ability to understand and provide informed consent
- Prior PD-(L)1 blockade treatment
- Chemotherapy within 6 months prior to enrollment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
Commack, New York, 11725
Memoral Sloan Kettering Westchester (Consent & Follow Up)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, 07645
Memorial Sloan - Kettering Cancer Center (Consent and follow-up)
New York, New York, 10021
About this study
Official title: Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pre-Treatment Biopsy, On-Treatment Biopsy, Biopsy at Disease Progression, Peripheral Blood-Based Studies
- Keywords
- PD-L1 High, 19-030, Memorial Sloan Kettering Cancer Center
- 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.
Pre-Treatment BiopsyDiagnostic test
Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.
On-Treatment BiopsyDiagnostic test
All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed ~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.
Biopsy at Disease ProgressionDiagnostic test
All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.
Peripheral Blood-Based StudiesDiagnostic test
All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.
| Study group | Role | What they receive |
|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry Receives: Diagnostic Test: Pre-Treatment Biopsy; Diagnostic Test: On-Treatment Biopsy; Diagnostic Test: Biopsy at Disease Progression; Diagnostic Test: Peripheral Blood-Based Studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start8 Mar 2019
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Why it stopped: The primary objectives have not been met due to no patient enrollment therefore, the PI is requesting to close the study at this time.
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 Memorial Sloan Kettering Cancer CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wang Initiative in Lung Cancer Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Matthew Hellmann, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877250
- Sponsor's protocol ID
- 19-030
- Status last verified
- Aug 2020
- First submitted
- 12 Mar 2019
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
- ClinicalTrials.gov ID
- NCT03877250
- Acronym / sponsor ID
- 19-030
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- PD-L1 High, 19-030, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The primary objectives have not been met due to no patient enrollment therefore, the PI is requesting to close the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Wang Initiative in Lung Cancer Clinical Trials
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 15 Mar 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.
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | – | Diagnostic Test: Pre-Treatment Biopsy, Diagnostic Test: On-Treatment Biopsy, Diagnostic Test: Biopsy at Disease Progression, Diagnostic Test: Peripheral Blood-Based StudiesParticipants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with newly diagnosed or recurrent, PD-L1 high (>50%) metastatic non-small cell lung cancer without prior PD-(L)1 therapy
Key inclusion criteria (4 listed)
- Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 >/= 50%)
- Intended treatment with a PD-(L)1 inhibitor
- Age >/= 18 years
- Karnofsky Performance Status >/= 70% and medically fit to undergo a biopsy procedure
Key exclusion criteria (5 listed)
- Any medical condition or any sites of disease that would preclude a biopsy
- Pregnant or breastfeeding women
- Cognitively impairment affecting ability to understand and provide informed consent
- Prior PD-(L)1 blockade treatment
- Chemotherapy within 6 months prior to enrollment
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 |
|---|---|---|
| Pre-Treatment BiopsyParticipants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started. | Diagnostic test | Non Small Cell Lung Cancer (NSCLC) |
| On-Treatment BiopsyAll participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed ~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response. | Diagnostic test | Non Small Cell Lung Cancer (NSCLC) |
| Biopsy at Disease ProgressionAll participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy. | Diagnostic test | Non Small Cell Lung Cancer (NSCLC) |
| Peripheral Blood-Based StudiesAll participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing. | Diagnostic test | Non Small Cell Lung Cancer (NSCLC) |
Primary outcome
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Matthew Hellmann, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 sites 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, run by Memorial Sloan Kettering Cancer Center at 6 sites 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 5 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: withdrawn, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC (time frame: 24 weeks). 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 15 May 2025.