GEMINI-NSCLC: NSCLC Biomarker Study

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Description

Non-interventional study that will be collecting clinical and molecular health information from patients with NSCLC who will receive longitudinal blood collection in addition to their standard of care therapy and disease surveillance.

Targeted Conditions

Study Overview

Start Date
June 22, 2022
Completion Date
February 1, 2027
Enrollment
813
Date Posted
February 11, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
MemorialCare
Fountain Valley, California 92708, United States

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720, United States

Hawaii Cancer Care
Honolulu, Hawaii 96813, United States

Community Health Network
Indianapolis, Indiana 46250, United States

University of Iowa
Iowa City, Iowa 52242, United States

Johns Hopkins University
Baltimore, Maryland 21287, United States

The Center for Cancer and Blood Disorder
Bethesda, Maryland 20817, United States

Oncology Hematology Associates
Springfield, Missouri 65807, United States

Nebraska Cancer Specialists
Omaha, Nebraska 68130, United States

Duke University
Durham, North Carolina 27710, United States

Southeastern Medical Oncology Center (SMOC)
Goldsboro, North Carolina 27534, United States

Aultman Hospital
Canton, Ohio 44710, United States

TriHealth Cancer Institute
Cincinnati, Ohio 45220, United States

OhioHealth Reseach Institute
Columbus, Ohio 43214, United States

Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma 74146, United States

Cancer Care Associates of York
York, Pennsylvania 17403, United States

Baptist Cancer Center
Memphis, Tennessee 38120, United States

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911, United States

Gundersen Health System
La Crosse, Wisconsin 54601, United States

Eligibility

Study Population
This protocol targets patients with Non-Small Cell Lung Cancer (NSCLC)
Minimum Age (years)
18
Eligibility Criteria
For Cohort 1 Inclusion, the participant has/is:

A known or suspected NSCLC treated with curative intent
Undergone or planning to undergo a surgical resection
18 years old or older
Willing and able to provide informed consent
Willing to have additional blood samples collected during routine surveillance visits

For Cohort 2 Inclusion, the participant has/is:

Histologically or cytologically documented Stage IV NSCLC (de novo metastatic or relapse setting) not amenable to curative surgery or radiation therapy.
Intended to receive first line immunotherapy (as monotherapy or in combination with chemotherapy)
Tumors that lack activating EGFR mutations and ALK fusions
18 years and older
Willing and able to provide informed consent
Willing to have additional blood samples collected during routine surveillance visits

Exclusion Criteria (both Cohorts):

Suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e., those without a known or suspected NSCLC primary diagnosis)
Not willing to have additional blood samples collected
Patients with a secondary malignancy <2 years prior to enrollment

Study Contact Info

Study Contact Name
GEMINI NSCLC
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05236114