Clinical trial NCT04180176: Prospective Clinicogenomic Program
Official title: A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Small-Cell Lung Cancer (SCLC)
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Flatiron Health, Inc.; Foundation Medicine, Inc.
First posted: 2019-11-27
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of Potential Eligible Participant Enrollment
timeFrame: Up to 5 years
measure: Proportion of Enrolled Participants Submitting Sufficient Blood Samples
timeFrame: 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 outcomes:
measure: Blood Level of ctDNA
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer & Research Centers
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; Department of Oncology
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist, North Region
state: Florida
city: Tallahassee
country: United States
facility: SCRI Florida Cancer Specialists PAN
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC; Research
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Med Oncology & Hematology Inc
state: Indiana
city: Grand Rapids
country: United States
facility: Cancer & Hematology Centers of Western Michigan
state: Michigan
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Ctr
state: Nebraska
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates LLC, Central Jersey Division
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York
state: New York
city: New York
country: United States
facility: West Clinic
state: New York
city: Port Jefferson Station
country: United States
facility: National Translational Research Group
state: New York
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg, Inc.
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute - Richmond
state: Virginia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: