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

Metastatic Lung Cancer Clinical Trial

— L1st  

Official title:

An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846594
• Other study ID #: MO43989
• Status: Recruiting
• Phase: Phase 4
• Start date: September 14, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: MO43989 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Metastatic Gastrointestinal Cancer
• Metastatic Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut Sainte Catherine;Recherche Clinique	Avignon
France	Hopital Marie Lannelongue	Le Plessis Robinson
France	Centre Oscar Lambret; Chir Cancerologie General	Lille
France	Centre Eugène Marquis	Rennes
France	CHU Strasbourg - Nouvel Hopital Civil	Strasbourg
France	Gustave Roussy	Villejuif
Germany	Asklepios Klinik Gauting; Onkologisches Studienzentrum	Gauting
Germany	Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II	Hamburg
Germany	Med. Hochschule Hannover	Hannover
Germany	Universität Mannheim; Personalisierte Onkologie	Mannheim
Germany	Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU	München
Germany	Klinikum Stuttgart - Katharinenhospital	Stuttgart
Italy	Ospedale Papardo- Piemonte;Oncologia Medica	Messina	Sicilia
Italy	Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica	Napoli	Campania
Italy	Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia	Udine	Friuli-Venezia Giulia
Italy	Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia	Verona	Veneto
Netherlands	Hagaziekenhuis, locatie Leyweg	Den-Haag
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Clinica Universidad de Navarra Madrid; Servicio de Oncología	Madrid
Spain	Hospital Universitario Son Espases; Servicio de Oncologia	Palma De Mallorca	Islas Baleares

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Foundation Medicine

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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.	Up to 12 weeks
Secondary	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.	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	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		Up to 12 weeks
Secondary	Percentage of Participants in Which the MGTO Recommendation Issued Was Discordant Between the Liquid Biopsy Results and the Standard of Care Diagnostic Pathway Results		Up to 12 weeks
Secondary	Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events		Up to 17 weeks