Prospective Clinicogenomic Program (PCG)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04180176 |
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Recruitment Status :
Active, not recruiting
First Posted : November 27, 2019
Last Update Posted : January 26, 2023
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Sponsor:
Genentech, Inc.
Collaborator:
Flatiron Health, Inc.; Foundation Medicine, Inc.
Information provided by (Responsible Party):
Genentech, Inc.
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) Small-Cell Lung Cancer (SCLC) | Other: Blood Draw | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1000 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program |
| Actual Study Start Date : | December 13, 2019 |
| Estimated Primary Completion Date : | March 27, 2025 |
| Estimated Study Completion Date : | March 27, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: All-Comer Cohort
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
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Other: Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy. |
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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.
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Other: Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy. |
Primary Outcome Measures :
- 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. ]
Secondary Outcome Measures :
- 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. ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180176
Locations
Show 23 study locations
Sponsors and Collaborators
Genentech, Inc.
Flatiron Health, Inc.; Foundation Medicine, Inc.
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT04180176 |
| Other Study ID Numbers: |
GX41563 |
| First Posted: | November 27, 2019 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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). |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |