Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC (NO3DEXPL)
|ClinicalTrials.gov Identifier: NCT03371992|
Recruitment Status : Enrolling by invitation
First Posted : December 13, 2017
Last Update Posted : March 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Nivolumab Diagnostic Test: 3D-EX Other: Evaluation of Response by RECIST||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pilot Study of the Nilogen Ex-Vivo Assay (3D-EX) and Its Ability to Predict Therapeutic Response to Anti-PD1 (Nivolumab, Embrolizumab) or Anti-PDL1(Atezolizumab) in Advanced Non-small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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.
Nivolumab, pembrolizumab or atezolizumab will be administered as per the established standard of care for the eligible population.
Diagnostic Test: 3D-EX
Analysis of drug-mediated changes in the tumor microenvironment.
Other Name: 3D ex vivo assay
Other: Evaluation of Response by RECIST
Evaluation of tumor response using the set of published rules to determine if a tumor has responded, is stable or progressed during treatments.
- 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. ]Complete Response (CR) is defined as disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of longest dimension (LD) of target lesions taking as reference the baseline sum LD Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371992
|United States, Michigan|
|Henry Ford Health Systems|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Soner Altiok, MD, PhD||Nilogen Oncosystems|
|Principal Investigator:||Igor Rybkin, MD||Henry Ford Health System|