Non-Small Cell Lung Cancer (NSCLC)Phase 4PCGNCT04180176
Prospective Clinicogenomic Program
A Phase 4 study testing Blood Draw in people with Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC), run by Genentech, Inc. at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC)
- What is being tested?
- Blood Draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 945 participants
- Where
- 23 sitesUnited States
- Study dates
- 13 Dec 2019to 30 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318
Alabama Oncology
Birmingham, Alabama, 35205
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404
Regional Cancer Care Associates LLC, Central Jersey Division
East Brunswick, New Jersey, 08816
Hematology Oncology Associates of Central New York
East Syracuse, New York, 13057
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, 33901-8101
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, 46845
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, 22408
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Clearview Cancer Institute
Huntsville, Alabama, 35805
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Southeast Nebraska Cancer Ctr
Lincoln, Nebraska, 68510
Tennessee Oncology
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06510
West Clinic
New York, New York, 10055
National Translational Research Group
Port Jefferson Station, New York, 11776
Virginia Cancer Institute - Richmond
Richmond, Virginia, 23236
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705
SCRI Florida Cancer Specialists PAN
Tallahassee, Florida, 32308
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146
Florida Cancer Specialists
West Palm Beach, Florida, 33401
About this study
Official title: 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.
- Being tested
- Blood Draw
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
| Study group | Role | What they receive |
|---|---|---|
| All-Comer Cohort | Experimental | Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling. Receives: Other: Blood Draw |
| Front-line Immunotherapy Re-enrollment Cohort | Experimental | 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. Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Potential Eligible Participant Enrollment
Measured: Up to 5 years
Proportion of Enrolled Participants Submitting Sufficient Blood Samples
Measured: 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 (1)
Blood Level of ctDNA
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start13 Dec 2019
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Flatiron Health, Inc.; Foundation Medicine, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180176
- Sponsor's protocol ID
- GX41563
- Acronym
- PCG
- Status last verified
- Jan 2024
- First submitted
- 19 Nov 2019
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program
- ClinicalTrials.gov ID
- NCT04180176
- Acronym / sponsor ID
- PCG / GX41563
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Flatiron Health, Inc.; Foundation Medicine, Inc.
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-Comer Cohort | Experimental | Other: Blood DrawParticipants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling. |
| Front-line Immunotherapy Re-enrollment Cohort | Experimental | Other: Blood DrawParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawParticipants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy. | Other | All-Comer Cohort, Front-line Immunotherapy Re-enrollment Cohort |
Primary outcome
Proportion of Potential Eligible Participant Enrollment
Time frame: 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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood Draw in people with Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC), run by Genentech, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Potential Eligible Participant Enrollment (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.