A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer

NCT05846594 | Completed

• 1 other identifier: MO43989
• Study Type: interventional
• Target: 463
• Locations: 4 countries
• Sites: 18

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.

Conditions

Metastatic Lung Cancer; Metastatic Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Median Time to Diagnosis

  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 Outcomes (8)

• Median Time to Treatment Recommendation

  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)

• Number of Molecular Testing Failures

  Up to 12 weeks

• Percentage of Participants in Which Comprehensive Genomic Profiling (CGP) Led to a Molecularly Guided Treatment Option (MGTO) Recommendation

  Up to 12 weeks

• 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

  Up to 12 weeks

• Percentage of Participants With Concordant CGP Results Between the Liquid Biopsy and the Standard of Care Diagnostic Pathway on the Gene Alteration Level

  Up to 12 weeks

Study Arms (4)

Basic Workup: Metastatic Lung Cancer Cohort

OTHER

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').

Diagnostic Test: FoundationOne® Liquid CDx Assay; Diagnostic Test: Standard of Care Diagnostic Pathway

Basic Workup: Metastatic Gastrointestinal Cancer Cohort

OTHER

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').

Diagnostic Test: FoundationOne® Liquid CDx Assay; Diagnostic Test: Standard of Care Diagnostic Pathway

Extended Workup: Metastatic Lung Cancer Cohort

OTHER

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').

Diagnostic Test: FoundationOne® Liquid CDx Assay; Diagnostic Test: Standard of Care Diagnostic Pathway

Extended Workup: Metastatic Gastrointestinal Cancer Cohort

OTHER

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').

Diagnostic Test: FoundationOne® Liquid CDx Assay; Diagnostic Test: Standard of Care Diagnostic Pathway

Interventions

FoundationOne® Liquid CDx Assay DIAGNOSTIC_TEST

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.

Basic Workup: Metastatic Gastrointestinal Cancer Cohort; Basic Workup: Metastatic Lung Cancer Cohort; Extended Workup: Metastatic Gastrointestinal Cancer Cohort; Extended Workup: Metastatic Lung Cancer Cohort

Standard of Care Diagnostic Pathway DIAGNOSTIC_TEST

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.

Basic Workup: Metastatic Gastrointestinal Cancer Cohort; Basic Workup: Metastatic Lung Cancer Cohort; Extended Workup: Metastatic Gastrointestinal Cancer Cohort; Extended Workup: Metastatic Lung Cancer Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Foundation Medicine: collaborator

Study Sites (18)

Institut Sainte Catherine

Avignon, 84918, France

Location

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

Hamburg, 20246, Germany

Location

Med. Hochschule Hannover

Hanover, 30625, Germany

Location

Universität Mannheim

Mannheim, 68167, Germany

Location

Klinikum der LMU München, Campus Großhadern, Krebszentrum München

München, 81377, Germany

Location

Asklepios Klinik Gauting

München-Gauting, 82131, Germany

Location

Klinikum Stuttgart - Katharinenhospital

Stuttgart, 70174, Germany

Location

Università degli Studi della Campania Luigi Vanvitelli

Naples, Campania, 80131, Italy

Location

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Veneto, 37126, Italy

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Cordoba, 14004, Spain

Location

Clinica Universidad de Navarra Madrid

Madrid, 28027, Spain

Location

MeSH Terms

Conditions

Lung Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: September 14, 2023
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); FR (6); IT (3); ES (3)