Metastatic Lung CancerL1stNCT05846594
A Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer
A study testing FoundationOne® Liquid CDx Assay in people with Metastatic Lung Cancer and Metastatic Gastrointestinal Cancer, run by Hoffmann-La Roche at 18 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Cancer, Metastatic Gastrointestinal Cancer
- What is being tested?
- FoundationOne® Liquid CDx Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 463 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 14 Sep 2023to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants presenting with a clinical diagnosis of advanced cancer, falling into one of the following two clinical presentations:
- 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:
- 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).
Who cannot join
- 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 locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
France6 sites
Institut Sainte Catherine
Avignon, 84918
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
Centre Oscar Lambret
Lille, 59000
Centre Eugène Marquis
Rennes, 35042
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, 67091
Gustave Roussy
Villejuif, 94800
Germany6 sites
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
Hamburg, 20246
Med. Hochschule Hannover
Hanover, 30625
Universität Mannheim
Mannheim, 68167
Klinikum der LMU München, Campus Großhadern, Krebszentrum München
München, 81377
Asklepios Klinik Gauting
München-Gauting, 82131
Klinikum Stuttgart - Katharinenhospital
Stuttgart, 70174
Italy3 sites
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80131
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli Venezia Giulia, 33100
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Veneto, 37126
Spain3 sites
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
Clinica Universidad de Navarra Madrid
Madrid, 28027
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)
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'.
Read more
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.
- Being tested
- FoundationOne® Liquid CDx Assay, Standard of Care Diagnostic Pathway
- Medical subject headings
- Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOne® Liquid CDx AssayDiagnostic 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.
Standard of Care Diagnostic PathwayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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'). Receives: 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'). Receives: 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'). Receives: 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'). Receives: Diagnostic Test: FoundationOne® Liquid CDx Assay; Diagnostic Test: Standard of Care Diagnostic Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Diagnosis
Measured: 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
Measured: 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
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.
Measured: Up to 12 weeks
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.
Measured: 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
Measured: 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
Measured: Up to 12 weeks
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
Measured: Up to 12 weeks
Percentage of Participants in Which the MGTO Recommendation Issued Was Discordant Between the Liquid Biopsy Results and the Standard of Care Diagnostic Pathway Results
Measured: Up to 12 weeks
Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events
Measured: Up to 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 Sep 2023
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation Medicine
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846594
- Sponsor's protocol ID
- MO43989
- Acronym
- L1st
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Prospective Study to Evaluate the Impact of Liquid Biopsy in Participants With a Clinical Diagnosis of Advanced Cancer (L1ST)
- ClinicalTrials.gov ID
- NCT05846594
- Acronym / sponsor ID
- L1st / MO43989
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Foundation Medicine
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Basic Workup: Metastatic Lung Cancer Cohort | Other | Diagnostic Test: FoundationOne® Liquid CDx Assay, Diagnostic Test: Standard of Care Diagnostic PathwayThis 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'). |
| Basic Workup: Metastatic Gastrointestinal Cancer Cohort | Other | Diagnostic Test: FoundationOne® Liquid CDx Assay, Diagnostic Test: Standard of Care Diagnostic PathwayThis 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'). |
| Extended Workup: Metastatic Lung Cancer Cohort | Other | Diagnostic Test: FoundationOne® Liquid CDx Assay, Diagnostic Test: Standard of Care Diagnostic PathwayThis 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'). |
| Extended Workup: Metastatic Gastrointestinal Cancer Cohort | Other | Diagnostic Test: FoundationOne® Liquid CDx Assay, Diagnostic Test: Standard of Care Diagnostic PathwayThis 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'). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants presenting with a clinical diagnosis of advanced cancer, falling into one of the following two clinical presentations:
- Participants who are treatment naïve for the metastatic setting under study
- Ability to comply with the study protocol
- Participants must either:
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoundationOne® Liquid CDx AssayParticipants 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. | Diagnostic test | 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 PathwayParticipants 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. | Diagnostic test | Basic Workup: Metastatic Gastrointestinal Cancer Cohort, Basic Workup: Metastatic Lung Cancer Cohort, Extended Workup: Metastatic Gastrointestinal Cancer Cohort, Extended Workup: Metastatic Lung Cancer Cohort |
Primary outcome
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)
8 secondary outcomes
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)
Number of Molecular Testing Failures
Time frame: Up to 12 weeks
Percentage of Participants in Which Comprehensive Genomic Profiling (CGP) Led to a Molecularly Guided Treatment Option (MGTO) Recommendation
Time frame: 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
Time frame: 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
Time frame: Up to 12 weeks
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
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
Incidence and Severity of Liquid Biopsy Sample Collection-Related Adverse Events
Time frame: Up to 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoundationOne® Liquid CDx Assay in people with Metastatic Lung Cancer and Metastatic Gastrointestinal Cancer, run by Hoffmann-La Roche at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.