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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

NCT03371992 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-03-27

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Nivolumab

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

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.

Sponsors & Collaborators

  • Henry Ford Health System

    collaborator OTHER

  • Nilogen Oncosystems

    lead INDUSTRY

Principal Investigators

  • Soner Altiok, MD, PhD · Nilogen Oncosystems

  • Igor Rybkin, MD · Henry Ford Health System

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-09
Primary Completion
2020-12-31
Completion
2021-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03371992 on ClinicalTrials.gov