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Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC (NO3DEXPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03371992
Recruitment Status : Unknown
Verified March 2020 by Nilogen Oncosystems.
Recruitment status was:  Enrolling by invitation
First Posted : December 13, 2017
Last Update Posted : March 27, 2020
Henry Ford Health System
Information provided by (Responsible Party):
Nilogen Oncosystems

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Drug: Nivolumab
Nivolumab, pembrolizumab or atezolizumab will be administered as per the established standard of care for the eligible population.
Other Names:
  • pembrolizumab
  • atezolizumab

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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

In order to be eligible for participation in this trial, the subject must:

  1. Be willing and able to provide written informed consent for the trial.
  2. Be at least 18 years of age on the day of signing informed consent.
  3. Have a histologic or cytologic diagnosis of Stage IV NSCLC.
  4. Must be medically eligible to receive nivolumab, pembrolizumab or atezolizumab as the standard of care for the next line of therapy (must have previously received first line platinum doublet chemotherapy) as determined by their oncologist.
  5. Have measurable disease based on RECIST 1.1 (see section 7.1 or appropriate number).
  6. Be willing and medically fit to undergo a fresh (newly obtained) diagnostic biopsy of a metastatic lesion or primary site of disease before receiving nivolumab, pembrolizumab or atezolizumab. "Fresh (newly-obtained)" is defined as a specimen obtained up to 6 weeks prior to initiation of treatment with nivolumab, pembrolizumab or atezolizumab on Day 1.
  7. Fit in either of these categories:

    1. Stage I-III NSCLC patients who develop metastatic disease within 6 months of receiving definitive (curative) treatment that includes platinum-based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
    2. Stage IV NSCLC patients with progression of disease following platinum based chemotherapy, and who require biopsy for either confirmation of diagnosis or further molecular or immunohistochemical testing to guide treatment.
    3. Stage IV NSCLC patients who will receive nivolumab, pembrolizumab or atezolizumab as the standard of care in special circumstances (eg, when chemotherapy is contraindicated or if a patient declines to be treated with chemotherapy).
  8. Be willing to undergo at least 4 fine needle aspirations for experimental purposes at the time of the standard of care biopsy.
  9. Have a performance status of 0 or 1 on the ECOG Performance Scale.

Exclusion Criteria:

The subject must be excluded from participating in the trial if the subject:

  1. Is currently participating in and receiving therapy as part of a different clinical trial.
  2. Is not a candidate to receive nivolumab, pembrolizumab or atezolizumab as determined by the patient's oncologist.
  3. Has an active infection requiring systemic therapy.
  4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might; (1) confound the results of the trial, (2) that would substantially increase risk of incurring adverse events (AEs) from nivolumab, pembrolizumab or atezolizumab, (3) that would interfere with the subject's participation for the full duration of the trial, or (4) is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  6. Is pregnant or breastfeeding.
  7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  8. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03371992

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United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Nilogen Oncosystems
Henry Ford Health System
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Principal Investigator: Soner Altiok, MD, PhD Nilogen Oncosystems
Principal Investigator: Igor Rybkin, MD Henry Ford Health System

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Responsible Party: Nilogen Oncosystems Identifier: NCT03371992    
Other Study ID Numbers: NO88352235
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will not be shared but the results of the clinical trial will be published in a peer-reviewed journal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nilogen Oncosystems:
drug mechanism
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action