Non-Small Cell Lung CancerNCT06630429
A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors
An observational study of Non-Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Renal Cell Carcinoma (RCC)
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Subjects receiving care at The Ohio State University Comprehensive Cancer Center
Who may be able to join
- Males and females, age ≥ 18 years
- Cohort A will include patients with confirmed diagnosis of all non-small cell lung cancer (NSCLC) histologies including adenocarcinoma, squamous cell, adenosquamous, sarcomatoid/pleomorphic, and poorly differentiated/NOS, as well as patients diagnosed with malignant pleural mesothelioma. Cohort B will include patients with confirmed diagnosis of RCC (clear cell or any non-clear cell histology) receiving first treatment with immunotherapy alone or in combination therapy for metastatic disease or as adjuvant or neoadjuvant therapy.
- Patients planned for standard of care treatment with immune checkpoint inhibitors (ICIs, see appendix 3 for list) either as monotherapy or in combination therapy.
- Scheduled for imaging every 6 to 12 weeks for stage IV NSCLC and RCC as is standard of care per NCCN guidelines.
- Able to read, understand, and provide written informed consent.
- Willing to provide blood specimen and stool samples for research studies as outlined in the calendar h. ECOG performance status 0-2 i. Life expectancy ≥ 3 months
Who cannot join
- Individuals <18 years of age
- Patients who have received previous immune checkpoint inhibitor therapy.
- Unable or unwilling to provide consent.
- Other malignancy requiring active ongoing treatment with systemic therapy (excluding hormonal therapy).
- Women who are known to be pregnant are excluded. However no additional pregnancy testing out of what would be recommended prior to initiating anti-cancer therapy will be performed solely for this study.
- Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Pilot Study of Blood-Based Biomarkers for Response to Immune Checkpoint Inhibitors
A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response. Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy. Measurements will include circulating IL-6 and other cytokine levels, glucocorticoid levels, ketone levels and stool analysis for assessment of gut microbiome.
Read the detailed description
Primary objective:
The primary objective of this protocol is to establish whether TFx can be reliably measured in patients with NSCLC and RCC undergoing treatment with ICI
Secondary objectives:
- To incorporate and evaluate relationships among other known risk factors for cachexia relative to ICI therapy pharmacokinetics and clinical outcomes (to include baseline and longitudinal measures of body weight, body composition determinations via L3 CT scans, and albumin for cachexia, and baseline ICI mAb clearance and changes in clearance over time for PK).
- To determine whether detected changes in TFx can be appreciated during treatment and whether these changes are associated with clinical benefit by RECIST v1.1, progression free survival (PFS) and overall survival (OS).
Exploratory Objectives:
- To determine potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy (by RECIST 1.1, PFS, and OS)
- This includes measurement of cytokines and other signaling markers, including, but not limited to IL-6, Interferon-γ and TGF-β
- Endogenous glucocorticoids and ketones
- Soluble PD-L1
- Ki-67+PD-1+CD8+ T cells, Treg cells, and PBMC analysis for measurement of expression of FcRn
- To quantify the performance of a modifiable biomarker - the gut microbiome - to use as a predictive indicator of clinical benefit in lung cancer patients who receive randomized treatment combinations.
- To determine whether TFx changes differ by stage of cancer or setting of ICI therapy in NSCLC 11
- To compare peripheral blood changes in inflammation including CD8+ T Cells and Treg
- Being tested
- Biospecimen Collection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
Undergo collection of blood and stool samples
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Includes patients with Stage IB-IV NSCLC receiving treatment with immune checkpoint inhibitors either alone or in combination with chemotherapy. Receives: Other: Biospecimen Collection | |
| Cohort B | Includes patients with metastatic RCC receiving first line combination with nivolumab and ipilimumab. Receives: Other: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with tumor fraction change
The primary outcome is the percentage of patients having >5% change (better or worse) in tumor fraction during the first two cycles. With 90 patients having detectable tumor fraction, the % of patients having >5% change in tumor fraction can be estimated with a 95% confidence interval of ±10%. Assuming the response rate of 30%, 27 responders will provide at least 80% power to detect an effect size of 0.5 standard deviations reduction of tumor fraction from baseline to treatment by cycle 3 at significance level of 0.05, based on a one-sided paired t-test. If the response rate is higher, a smaller reduction can be detected.
Measured: From enrollment up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start2 Sep 2020
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwight Owen, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630429
- Sponsor's protocol ID
- OSU-20001
- Status last verified
- Sep 2026
- First submitted
- 4 Oct 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Blood-Based Biomarkers for Response to Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06630429
- Acronym / sponsor ID
- OSU-20001
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response. Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy. Measurements will include circulating IL-6 and other cytokine levels, glucocorticoid levels, ketone levels and stool analysis for assessment of gut microbiome.
Detailed description
Primary objective:
The primary objective of this protocol is to establish whether TFx can be reliably measured in patients with NSCLC and RCC undergoing treatment with ICI
Secondary objectives:
- To incorporate and evaluate relationships among other known risk factors for cachexia relative to ICI therapy pharmacokinetics and clinical outcomes (to include baseline and longitudinal measures of body weight, body composition determinations via L3 CT scans, and albumin for cachexia, and baseline ICI mAb clearance and changes in clearance over time for PK).
- To determine whether detected changes in TFx can be appreciated during treatment and whether these changes are associated with clinical benefit by RECIST v1.1, progression free survival (PFS) and overall survival (OS).
Exploratory Objectives:
- To determine potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy (by RECIST 1.1, PFS, and OS)
- This includes measurement of cytokines and other signaling markers, including, but not limited to IL-6, Interferon-γ and TGF-β
- Endogenous glucocorticoids and ketones
- Soluble PD-L1
- Ki-67+PD-1+CD8+ T cells, Treg cells, and PBMC analysis for measurement of expression of FcRn
- To quantify the performance of a modifiable biomarker - the gut microbiome - to use as a predictive indicator of clinical benefit in lung cancer patients who receive randomized treatment combinations.
- To determine whether TFx changes differ by stage of cancer or setting of ICI therapy in NSCLC 11
- To compare peripheral blood changes in inflammation including CD8+ T Cells and Treg
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: Biospecimen CollectionIncludes patients with Stage IB-IV NSCLC receiving treatment with immune checkpoint inhibitors either alone or in combination with chemotherapy. |
| Cohort B | – | Other: Biospecimen CollectionIncludes patients with metastatic RCC receiving first line combination with nivolumab and ipilimumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects receiving care at The Ohio State University Comprehensive Cancer Center
Key inclusion criteria (6 listed)
- Males and females, age ≥ 18 years
- Cohort A will include patients with confirmed diagnosis of all non-small cell lung cancer (NSCLC) histologies including adenocarcinoma, squamous cell, adenosquamous, sarcomatoid/pleomorphic, and poorly differentiated/NOS, as well as patients diagnosed with malignant pleural mesothelioma. Cohort B will include patients with confirmed diagnosis of RCC (clear cell or any non-clear cell histology) receiving first treatment with immunotherapy alone or in combination therapy for metastatic disease or as adjuvant or neoadjuvant therapy.
- Patients planned for standard of care treatment with immune checkpoint inhibitors (ICIs, see appendix 3 for list) either as monotherapy or in combination therapy.
- Scheduled for imaging every 6 to 12 weeks for stage IV NSCLC and RCC as is standard of care per NCCN guidelines.
- Able to read, understand, and provide written informed consent.
Key exclusion criteria (6 listed)
- Individuals <18 years of age
- Patients who have received previous immune checkpoint inhibitor therapy.
- Unable or unwilling to provide consent.
- Other malignancy requiring active ongoing treatment with systemic therapy (excluding hormonal therapy).
- Women who are known to be pregnant are excluded. However no additional pregnancy testing out of what would be recommended prior to initiating anti-cancer therapy will be performed solely for this study.
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and stool samples | Other | Cohort A, Cohort B |
Primary outcome
Percentage of patients with tumor fraction change
Time frame: From enrollment up to 12 months
The primary outcome is the percentage of patients having >5% change (better or worse) in tumor fraction during the first two cycles. With 90 patients having detectable tumor fraction, the % of patients having >5% change in tumor fraction can be estimated with a 95% confidence interval of ±10%. Assuming the response rate of 30%, 27 responders will provide at least 80% power to detect an effect size of 0.5 standard deviations reduction of tumor fraction from baseline to treatment by cycle 3 at significance level of 0.05, based on a one-sided paired t-test. If the response rate is higher, a smaller reduction can be detected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Cell Carcinoma (RCC), run by Ohio State University Comprehensive Cancer Center 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of patients with tumor fraction change (time frame: From enrollment up to 12 months). 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 30 Sep 2026.