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| Name | Class |
|---|---|
| Flatiron Health, Inc.; Foundation Medicine, Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All-Comer Cohort | Experimental | Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Draw | Other | Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Potential Eligible Participant Enrollment | Up to 5 years | |
| Proportion of Enrolled Participants Submitting Sufficient Blood Samples | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Level of ctDNA | 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35205 | United States | ||
| Clearview Cancer Institute |
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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| Huntsville |
| Alabama |
| 35805 |
| United States |
| Ironwood Cancer & Research Centers | Chandler | Arizona | 85224 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Florida Cancer Specialists; Department of Oncology | Fort Myers | Florida | 33901-8101 | United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | 32308 | United States |
| Florida Cancer Specialists | West Palm Beach | Florida | 33401 | United States |
| University Cancer & Blood Center, LLC; Research | Athens | Georgia | 30607 | United States |
| Piedmont Cancer Institute, PC | Atlanta | Georgia | 30318 | United States |
| Fort Wayne Med Oncology & Hematology Inc | Fort Wayne | Indiana | 46845 | United States |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | United States |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | United States |
| Southeast Nebraska Cancer Ctr | Lincoln | Nebraska | 68510 | United States |
| Regional Cancer Care Associates LLC, Central Jersey Division | East Brunswick | New Jersey | 08816 | United States |
| Hematology Oncology Associates of Central New York | East Syracuse | New York | 13057 | United States |
| West Clinic | New York | New York | 10055 | United States |
| National Translational Research Group | Port Jefferson Station | New York | 11776 | United States |
| Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | 74146 | United States |
| SCRI Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | 22408 | United States |
| Virginia Cancer Institute - Richmond | Richmond | Virginia | 23236 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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