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Prospective Clinicogenomic Program (PCG)

Primary Purpose

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

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Blood Draw
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Oncology
  • Clearview Cancer Institute
  • Ironwood Cancer & Research Centers
  • Yale University
  • Florida Cancer Specialists; Department of Oncology
  • Florida Cancer Specialist, North Region
  • SCRI Florida Cancer Specialists PAN
  • Florida Cancer Specialists
  • University Cancer & Blood Center, LLC; Research
  • Piedmont Cancer Institute, PC
  • Fort Wayne Med Oncology & Hematology Inc
  • Cancer & Hematology Centers of Western Michigan
  • Jackson Oncology Associates, PLLC
  • Southeast Nebraska Cancer Ctr
  • Regional Cancer Care Associates LLC, Central Jersey Division
  • Hematology Oncology Associates of Central New York
  • West Clinic
  • National Translational Research Group
  • Oklahoma Cancer Specialists and Research Institute
  • SCRI Tennessee Oncology Chattanooga
  • Tennessee Oncology
  • Hematology Oncology Associates of Fredericksburg, Inc.
  • Virginia Cancer Institute - Richmond

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

All-Comer Cohort

Front-line Immunotherapy Re-enrollment Cohort

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Proportion of Potential Eligible Participant Enrollment
Proportion of Enrolled Participants Submitting Sufficient Blood Samples

Secondary Outcome Measures

Blood Level of ctDNA

Full Information

First Posted
November 19, 2019
Last Updated
October 18, 2023
Sponsor
Genentech, Inc.
Collaborators
Flatiron Health, Inc.; Foundation Medicine, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04180176
Brief Title
Prospective Clinicogenomic Program
Acronym
PCG
Official Title
A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
March 27, 2025 (Anticipated)
Study Completion Date
March 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Flatiron Health, Inc.; Foundation Medicine, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC)

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All-Comer Cohort
Arm Type
Experimental
Arm Description
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
Arm Title
Front-line Immunotherapy Re-enrollment Cohort
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Draw
Intervention Description
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Primary Outcome Measure Information:
Title
Proportion of Potential Eligible Participant Enrollment
Time Frame
Up to 5 years
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Clearview Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Ironwood Cancer & Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Florida Cancer Specialists; Department of Oncology
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
SCRI Florida Cancer Specialists PAN
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
University Cancer & Blood Center, LLC; Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Piedmont Cancer Institute, PC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Fort Wayne Med Oncology & Hematology Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Jackson Oncology Associates, PLLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Southeast Nebraska Cancer Ctr
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Regional Cancer Care Associates LLC, Central Jersey Division
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Hematology Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
West Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10055
Country
United States
Facility Name
National Translational Research Group
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Virginia Cancer Institute - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23236
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

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Prospective Clinicogenomic Program

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