Prospective Clinicogenomic Program

NCT ID: NCT04180176

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

945 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-13

Study Completion Date

2023-11-30

Brief Summary

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The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All-Comer Cohort

Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.

Group Type EXPERIMENTAL

Blood Draw

Intervention Type OTHER

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Front-line Immunotherapy Re-enrollment Cohort

Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.

Group Type EXPERIMENTAL

Blood Draw

Intervention Type OTHER

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Interventions

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Blood Draw

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Documented diagnosis of mNSCLC or ES-SCLC
* Planned initiation of SOC systemic anti-cancer treatment
* Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

Exclusion Criteria

\- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Flatiron Health, Inc.; Foundation Medicine, Inc.

UNKNOWN

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Alabama Oncology

Birmingham, Alabama, United States

Site Status

Clearview Cancer Institute

Huntsville, Alabama, United States

Site Status

Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Florida Cancer Specialists; Department of Oncology

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialist, North Region

St. Petersburg, Florida, United States

Site Status

SCRI Florida Cancer Specialists PAN

Tallahassee, Florida, United States

Site Status

Florida Cancer Specialists

West Palm Beach, Florida, United States

Site Status

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States

Site Status

Piedmont Cancer Institute, PC

Atlanta, Georgia, United States

Site Status

Fort Wayne Med Oncology & Hematology Inc

Fort Wayne, Indiana, United States

Site Status

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

Jackson Oncology Associates, PLLC

Jackson, Mississippi, United States

Site Status

Southeast Nebraska Cancer Ctr

Lincoln, Nebraska, United States

Site Status

Regional Cancer Care Associates LLC, Central Jersey Division

East Brunswick, New Jersey, United States

Site Status

Hematology Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

West Clinic

New York, New York, United States

Site Status

National Translational Research Group

Port Jefferson Station, New York, United States

Site Status

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, United States

Site Status

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

Site Status

Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

Site Status

Virginia Cancer Institute - Richmond

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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GX41563

Identifier Type: -

Identifier Source: org_study_id

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