Prospective Clinicogenomic Program (PCG)

January 15, 2024 updated by: Genentech, Inc.

A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

945

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Oncology
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer & Research Centers
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists; Department of Oncology
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialist, North Region
      • Tallahassee, Florida, United States, 32308
        • SCRI Florida Cancer Specialists PAN
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC; Research
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, PC
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Med Oncology & Hematology Inc
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer & Hematology Centers of Western Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Jackson Oncology Associates, PLLC
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Ctr
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Regional Cancer Care Associates LLC, Central Jersey Division
    • New York
      • East Syracuse, New York, United States, 13057
        • Hematology Oncology Associates of Central New York
      • New York, New York, United States, 10055
        • West Clinic
      • Port Jefferson Station, New York, United States, 11776
        • National Translational Research Group
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Scri Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg, Inc.
      • Richmond, Virginia, United States, 23236
        • Virginia Cancer Institute - Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All-Comer Cohort
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
Other: Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Experimental: 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.
Other: Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Potential Eligible Participant Enrollment
Time Frame: Up to 5 years
Up to 5 years
Proportion of Enrolled Participants Submitting Sufficient Blood Samples
Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.
At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Level of ctDNA
Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.
At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

Flatiron Health, Inc.; Foundation Medicine, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2019

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX41563

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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