Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Nilogen Oncosystems
Study ID
NCT03371992
Phase
EARLY_PHASE1
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab, pembrolizumab or atezolizumab will be administered as per the established standard of care for the eligible population.
  • 3D-EX — DIAGNOSTIC_TEST
    Analysis of drug-mediated changes in the tumor microenvironment.
  • Evaluation of Response by RECIST — OTHER
    Evaluation of tumor response using the set of published rules to determine if a tumor has responded, is stable or progressed during treatments.

Study Details

Subjects will be eligible for this study if they are about to start on a drug called nivolumab for lung cancer. Some patients' cancers respond to nivolumab but a majority of patients do not. To better determine which patients will most likely respond to nivolumab or not, the investigators are testing an assay that tests biopsy tissue to determine if the subject's tumor will likely respond to nivolumab. The main purpose of this research study is to see if this specialized test can help identify people with locally advanced or metastatic non-small cell lung cancer who are more likely to benefit from treatment with nivolumab. The results of the tests will not affect whether or not subjects receive nivolumab but may help identify future patients who are more likely to benefit from nivolumab. The study assay is extra and experimental.

Key Dates

Start date
Mar 9, 2018
Status verified
Mar 2020
Primary completion
Dec 31, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Lung Cancer Patients
    Lung cancer patients receiving one of three standard of care immunotherapy drugs including nivolumab, pembrolizumab or atezolizumab. 3D-EX will be performed on biopsies from patients enrolled in the study to correlate with the patient's evaluation of response by RECIST.

Primary Outcome Measure

Evaluation of target lesions by RECIST [ Time Frame: Tumor size is assessed via CT every 8 weeks and RECIST criteria will be documented every 8 weeks after the first treatment for progression or date of death, whichever comes first, for up to 60 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Health SystemsDetroitMichigan48202-

Find similar trials in Detroit, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Henry Ford Health Systems· Detroit, MI

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