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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

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

Other trials in United States

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

Conditions: Non-Small Cell Lung Cancer, Renal Cell Carcinoma (RCC)
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 groups in NCT06630429
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.

2 Sep 202031 Jul 2027

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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