Back to resultsA Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1st)
Primary Purpose
Metastatic Lung Cancer, Metastatic Gastrointestinal Cancer
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
FoundationOne® Liquid CDx Assay
Standard of Care Diagnostic Pathway
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Lung Cancer
Eligibility Criteria
Inclusion Criteria: Participants presenting with a clinical diagnosis of advanced cancer, falling into one of the following two clinical presentations: i) De novo metastatic lung cancer as evidenced by imaging demonstrating a lung nodule/mass and objective evidence of a metastatic process; OR, ii) De novo metastatic gastrointestinal cancer as evidenced by imaging demonstrating a metastatic process in the abdomen/pelvis Participants who are treatment naïve for the metastatic setting under study Ability to comply with the study protocol Participants must either: i) Have a tissue biopsy intended/planned to confirm malignant disease and histology; OR, ii) Have a tissue biopsy already performed but pathology has not yet been finalized. If a tissue biopsy has already been performed prior to ICF signature, then the subtyping of primary tumor may have already been assessed (i.e., for lung cancer TTF1, p40, and napsin A IHC staining may have already been performed). Exclusion Criteria: Participants deemed not fit for treatment with systemic therapy Participants deemed not fit for tissue biopsy Participants with hematological neoplasm Participants with primary malignant neoplasm of the brain Participants with any previous molecular testing (NGS or other methods) e.g., all immunohistochemistry staining recommended by ESMO aiming to define the treatment decision (i.e., for lung cancer ALK, EGFR, and PD-L1 IHC staining must not have already been performed). Participants in which tissue biopsy and primary histotyping have been performed can be included in the study. Prior treatment for metastatic cancer with the exception of participants who have already been diagnosed and treated for cancer, other than the cancer type under study, who have no evidence of relapse History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Sites / Locations
- Institut Sainte Catherine;Recherche CliniqueRecruiting
- Centre Eugène MarquisRecruiting
- Gustave RoussyRecruiting
- Asklepios Klinik München-GautingRecruiting
- Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia MedicaRecruiting
- Ospedale Papardo- Piemonte;Oncologia MedicaRecruiting
- Azienda Ospedaliera Universitaria Integrata Verona; UOC OncologiaRecruiting
- Hospital Universitario Reina Sofia; Servicio de OncologiaRecruiting
- Hospital Universitario Son Espases; Servicio de OncologiaRecruiting
- Clinica Universidad de Navarra Madrid; Servicio de OncologíaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Basic Workup: Metastatic Lung Cancer Cohort
Basic Workup: Metastatic Gastrointestinal Cancer Cohort
Extended Workup: Metastatic Lung Cancer Cohort
Extended Workup: Metastatic Gastrointestinal Cancer Cohort
Arm Description
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic lung cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic lung cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').
Outcomes
Primary Outcome Measures
Median Time to Diagnosis
Secondary Outcome Measures
Median Time to Treatment Recommendation
Number of Molecular Testing Failures
Molecular testing failure is defined as cases in which the results of liquid biopsy or tissue biopsy/standard of care cannot be delivered to the treating physician.
Percentage of Participants in Which Comprehensive Genomic Profiling (CGP) Led to a Molecularly Guided Treatment Option (MGTO) Recommendation
CGP refers to both the liquid biopsy and the standard of care diagnostic pathway.
Percentage of Participants Diagnosed with an Actionable Driver Mutation Who Did Not Receive a MGTO Because Anticancer Treatment Needed to Begin Before the CGP Results Were Available
Percentage of Participants With Concordant CGP Results Between the Liquid Biopsy and the Standard of Care Diagnostic Pathway on the Gene Alteration Level
Percentage of Participants in Which Treatment Recommendation Based on Molecular Data from the Liquid Biopsy Were the Same as That Based on the Standard of Care Diagnostic Pathway
Percentage of Participants in Which the MGTO Recommendation Issued Was Discordant Between the Liquid Biopsy Results and the Standard of Care Diagnostic Pathway Results
Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events
Full Information
NCT ID
NCT05846594
First Posted
April 27, 2023
Last Updated
October 20, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Foundation Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05846594
Brief Title
A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
Acronym
L1st
Official Title
An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Foundation Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an international, prospective study to assess the impact of concomitant early use of liquid biopsy (FoundationOne® Liquid CDx) within the diagnostic pathway, compared with the standard of care diagnostic pathway, on the timing of routine cancer care in treatment-naïve participants presenting with a clinical diagnosis of advanced cancer, where the pathologic diagnosis has not yet been confirmed. Participants with one of the following two clinical presentations will be included: participants with evidence of de novo metastatic lung cancer or participants with evidence of de novo metastatic gastrointestinal cancer.
Participants may have undergone different levels of diagnostic workup prior to enrollment. Participants who have not had tissue biopsy performed prior to enrollment will be classified as 'basic workup' and those who have had tissue biopsy performed prior to enrollment will be classified as 'extended workup'.
During the diagnosis period, eligible participants will undergo liquid biopsy (FoundationOne® Liquid CDx assay; as per label) on blood samples. Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. In parallel, participants will undergo the standard of care diagnostic pathway, including tissue biopsy and histology workup, if not already done before enrollment, and molecular workup according to ESMO guidelines or national guidelines for each tumor type included in this study.
Once a complete pathologic diagnosis has been made, the investigator (or multidisciplinary team) can complete an anti-cancer treatment recommendation assessment. Anti-cancer treatment recommendation should follow current practice and professional guidelines based on the results provided by either liquid biopsy (as per label) or tissue biopsy/standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Lung Cancer, Metastatic Gastrointestinal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basic Workup: Metastatic Lung Cancer Cohort
Arm Type
Other
Arm Description
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic lung cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
Arm Title
Basic Workup: Metastatic Gastrointestinal Cancer Cohort
Arm Type
Other
Arm Description
This cohort will enroll approximately 160 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have not had tissue biopsy performed prior to enrollment (classified as 'basic workup').
Arm Title
Extended Workup: Metastatic Lung Cancer Cohort
Arm Type
Other
Arm Description
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic lung cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').
Arm Title
Extended Workup: Metastatic Gastrointestinal Cancer Cohort
Arm Type
Other
Arm Description
This cohort will enroll approximately 100 participants who have clinical evidence of de novo metastatic gastrointestinal cancer and who have had tissue biopsy performed prior to enrollment (classified as 'extended workup').
Intervention Type
Diagnostic Test
Intervention Name(s)
FoundationOne® Liquid CDx Assay
Intervention Description
Participants will undergo liquid biopsy (FoundationOne® Liquid CDx) on blood samples collected once they have a clinical diagnosis of advanced cancer (as per label). Blood samples will be tested using the FoundationOne® Liquid CDx assay at a central laboratory. Results of the FoundationOne® Liquid CDx assay will be provided to the investigator to be used in accordance with professional guidelines in oncology for patients with malignant neoplasms.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of Care Diagnostic Pathway
Intervention Description
Participants will undergo the local standard of care diagnostic pathway including tissue biopsy/standard of care (if tissue not available), pathology workup, and molecular workup, according to ESMO guidelines or national guidelines for each tumor type included in this study.
Primary Outcome Measure Information:
Title
Median Time to Diagnosis
Time Frame
From the date of first request for biopsy (tissue or blood) by a healthcare professional to the date of complete pathologic diagnosis (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Median Time to Treatment Recommendation
Time Frame
From the date of first request for biopsy (tissue or blood) by a healthcare professional to the date of investigator's anticancer treatment recommendation (up to 12 weeks)
Title
Number of Molecular Testing Failures
Description
Molecular testing failure is defined as cases in which the results of liquid biopsy or tissue biopsy/standard of care cannot be delivered to the treating physician.
Time Frame
Up to 12 weeks
Title
Percentage of Participants in Which Comprehensive Genomic Profiling (CGP) Led to a Molecularly Guided Treatment Option (MGTO) Recommendation
Description
CGP refers to both the liquid biopsy and the standard of care diagnostic pathway.
Time Frame
Up to 12 weeks
Title
Percentage of Participants Diagnosed with an Actionable Driver Mutation Who Did Not Receive a MGTO Because Anticancer Treatment Needed to Begin Before the CGP Results Were Available
Time Frame
Up to 12 weeks
Title
Percentage of Participants With Concordant CGP Results Between the Liquid Biopsy and the Standard of Care Diagnostic Pathway on the Gene Alteration Level
Time Frame
Up to 12 weeks
Title
Percentage of Participants in Which Treatment Recommendation Based on Molecular Data from the Liquid Biopsy Were the Same as That Based on the Standard of Care Diagnostic Pathway
Time Frame
Up to 12 weeks
Title
Percentage of Participants in Which the MGTO Recommendation Issued Was Discordant Between the Liquid Biopsy Results and the Standard of Care Diagnostic Pathway Results
Time Frame
Up to 12 weeks
Title
Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events
Time Frame
Up to 17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants presenting with a clinical diagnosis of advanced cancer, falling into one of the following two clinical presentations:
i) De novo metastatic lung cancer as evidenced by imaging demonstrating a lung nodule/mass and objective evidence of a metastatic process; OR, ii) De novo metastatic gastrointestinal cancer as evidenced by imaging demonstrating a metastatic process in the abdomen/pelvis
Participants who are treatment naïve for the metastatic setting under study
Ability to comply with the study protocol
Participants must either:
i) Have a tissue biopsy intended/planned to confirm malignant disease and histology; OR, ii) Have a tissue biopsy already performed but pathology has not yet been finalized.
If a tissue biopsy has already been performed prior to ICF signature, then the subtyping of primary tumor may have already been assessed (i.e., for lung cancer TTF1, p40, and napsin A IHC staining may have already been performed).
Exclusion Criteria:
Participants deemed not fit for treatment with systemic therapy
Participants deemed not fit for tissue biopsy
Participants with hematological neoplasm
Participants with primary malignant neoplasm of the brain
Participants with any previous molecular testing (NGS or other methods) e.g., all immunohistochemistry staining recommended by ESMO aiming to define the treatment decision (i.e., for lung cancer ALK, EGFR, and PD-L1 IHC staining must not have already been performed). Participants in which tissue biopsy and primary histotyping have been performed can be included in the study.
Prior treatment for metastatic cancer with the exception of participants who have already been diagnosed and treated for cancer, other than the cancer type under study, who have no evidence of relapse
History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MO43989 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
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
Institut Sainte Catherine;Recherche Clinique
City
Avignon
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik München-Gauting
City
München-Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Papardo- Piemonte;Oncologia Medica
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98158
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Son Espases; Servicio de Oncologia
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra Madrid; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For eligible studies, qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Learn more about this trial
A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
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