A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1st)

Roche

Status: Completed

Conditions: Metastatic Gastrointestinal Cancer; Metastatic Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05846594

MO43989

Details and patient eligibility

About

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.

Enrollment: 463 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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463 participants in 4 patient groups

Basic Workup: Metastatic Lung Cancer Cohort

Other group

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').

Treatment:

Diagnostic Test: FoundationOne® Liquid CDx Assay

Diagnostic Test: Standard of Care Diagnostic Pathway

Basic Workup: Metastatic Gastrointestinal Cancer Cohort

Other group

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').

Treatment:

Diagnostic Test: FoundationOne® Liquid CDx Assay

Diagnostic Test: Standard of Care Diagnostic Pathway

Extended Workup: Metastatic Lung Cancer Cohort

Other group

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').

Treatment:

Diagnostic Test: FoundationOne® Liquid CDx Assay

Diagnostic Test: Standard of Care Diagnostic Pathway

Extended Workup: Metastatic Gastrointestinal Cancer Cohort

Other group

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').

Treatment:

Diagnostic Test: FoundationOne® Liquid CDx Assay

Diagnostic Test: Standard of Care Diagnostic Pathway