Advanced Solid TumorPROFILER 02NCT03163732
Evaluation of the Added Value of a Large Molecular Profiling Panel Versus a Limited Molecular Profiling Panel in Advanced Solid Tumors.
A study testing Blood and tumor samples in people with Advanced Solid Tumor, run by Centre Leon Berard at 15 sites in France.
Trial summary
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Blood and tumor samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 15 sitesFrance
- Study dates
- 29 Jun 2017to 23 Nov 2021
- 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
- Male or female patient aged ≥ 18 years at time of inform consent signature.
- Currently treated by a first or a second line of chemotherapy for their advanced cancer (local relapse or metastatic; Immunotherapies, Endocrine therapies and Targeted therapies are not considered as a line of chemotherapy).
- Histologically confirmed diagnosis of advanced (local relapse or metastatic), incurable solid tumors from any histological types (except those listed in exclusion criteria 3).
- I4. Availability of an adequate tumor sample to be sent imperatively to the CLB within 15 days after ICF signature by order of preference either (i1) a tumor archival FFPE block not older than 3 months prior to ICF signature or if not available :(ii2) a dedicated biopsy from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm or if not feasible (3) an archival tumor sample (primary tumor or metastatic lesion) not older than 3 years at time of ICF signature. Quality (at least 20-30% of tumor cells) and quantity (sample size surface area > 5mm2 and > 90um depth) of the tumor sample have to be confirmed mandatorily within 7 days by a central pathological review before confirmation of inclusion.
- Patient's disease which is not susceptible to progress during the next 45 days following the ICF signature.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
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- Adequate organ and marrow function based on a medical records (within 21 days before randomization) as defined below :
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Lymphocyte count ≥ 1 x 109/L
- Serum creatinine CL > 50 mL/min per 1.73m2 using MDRD or CKD-EPI
- AST and ALT ≤ 2.5 Upper Limit Normal (ULN) (up to 5 ULN may be tolerated in case of liver metastases)
- Serum bilirubin ≤ 1. 5 ULN (in the absence of Gilbert's syndrome).
- Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patient must be covered by a medical insurance.
Who cannot join
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
- Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate an anti-cancer treatment and its procedures (these conditions include but are not limited to severely impaired lung function, active gastrointestinal tract ulceration, acute or chronic uncontrolled liver disease/or severe renal disease, uncontrolled diabetes, history of HIV infection/or active viral infection (HBV, HCV), history of organ allograft or patient taking immunosuppressive treatment).
- Patient with the following advanced cancers :
- Cancer bearing one of the oncogenic driver mutation: Colorectal cancer : KRAS, NRAS, HRAS and BRAF/Lung cancer: ALK, EGFR, ROS or MET/Breast cancers : RH+ and/or HER2+
- High-grade serous ovarian cancers platinum-sensitive,
- Liposarcoma.
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- Melanoma: BRAF
- Patient with non assessable tumor sample.
- Patient already included in this study for a type of cancer, can't be included a second time for the same cancer or for any other type of cancer.
- Pregnant or breastfeeding woman
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Institut Bergonié
Bordeaux, 33076
Centre Jean PERRIN
Clermont-Ferrand
Centre Georges François LECLERC
Dijon
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon, 69008
Hôpital Privé Jean Mermoz
Lyon
Institut Paoli Calmettes
Marseille, 13273
AP-HM MARSEILLE - Hôpital Nord
Marseille, 13915
Institut cancer Montpellier - ICM
Montpellier
Institut Curie
Paris, 75231
Hopital Tenon
Paris, 75970
Centre Eugène Marquis
Rennes
ICO site René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie Lucien NEUWIRTH
Saint-Priest-en-Jarez, 422270
Institut Claudius Regaud
Toulouse, 31059
About this study
Official title: A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.
This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).
Read the detailed description
The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample.
For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given patient based on its molecular profile. First, the genomics data issued from the panel defined by the randomization will be reviewed and recommended therapy resulting from randomization will be revealed to the Investigator. If a recommended therapy can be identified, this therapy will be recommended.
If none recommended therapy can be identified, the 2nd panel performed will then be reviewed.
In case of confirmed clinical or radiological progression (at Investigator's discretion) and/or unacceptable toxicity as per Investigator judgment during the line of therapy recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other treatment options. All results will be disclosed to Investigator in order to offer other treatment options.
- Conditions
- Advanced Solid Tumor
- Being tested
- Blood and tumor samples
- Keywords
- Solid tumor, Advanced tumor, Profiling panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tumor samplesGenetic
Also called Evaluation of the added value of a molecular profiling panel
Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
| Study group | Role | What they receive |
|---|---|---|
| Large molecular profiling panel | Other | This panel is FOne Panel with a 324 cancer-related gene. Receives: Genetic: Blood and tumor samples |
| Limited molecular profiling panel | Other | This panel is CONTROL Panel with a 87 cancer-related gene. Receives: Genetic: Blood and tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proportion of patients for whom a genomically identified recommended therapy could be initiated using the large NGS panel from FoundationOne versus the limited CONTROL panel.
Measured: 28 months
Secondary outcomes (10)
Compare in the 2 randomization arms the number of patients with at least one actionable alteration.
Measured: 28 months
Compare in the 2 randomization arms the proportion of patients for which a genomically identified recommended therapy is effectively initiated.
Measured: 28 months
Describe in both arms the number of patients for whom a genomically identified recommended therapy was available but not initiated.
Measured: 28 months
Evaluate proportion of patients who could have been initiated a recommended therapy considering only the INCa panel.
Evaluate proportion of patients with at least one actionable alteration and for whom a genomically identified recommended therapy could have been initiated considering only the INCa panel with only 16 cancer-related genes already included in CONTROL panel
Measured: 28 months
Progression-Free Survival (PFS)
Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.
Measured: 24 months
Overall response Rate (ORR)
the most clinically favorable response recorded from the start of a recommended therapy until the end of treatment, according to RECIST 1.1
Measured: 24 months
Duration of response (DoR)
Calculated from date of first documented objective response (i.e., Complete Response or Partial Response) until date of first documented progression disease (measurements according to RECIST 1.1 criteria).
Measured: 24 months
Patient Quality Of Life
Measured by the questionnaire EuroQoL-5Dimension-3L
Measured: 12 months
Perform a health economic evaluation
A Cost-Effectiveness and a Cost-utility Analyses comparing the two molecular profiling strategies.
Measured: 12 months
Perform a health economic evaluation
A budget impact analysis to estimate the financial consequences of adoption and diffusion of the large FondationOne panel.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start29 Jun 2017
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Arm A: Tumor-based genomics according to the 324 cancer-related genes Next Generation Sequencing (NGS) panel from Foundation One (FOne panel). * Arm B: Tumor-based genomics according to the 87 cancer-related genes NGS panel performed at Centre Leon Berard "Unité de Caractérisation Tumorale" (CONTROL panel). Both panels will be performed concomitantly for all patients using the same patient tumor specimen.
- Masking
- None (open label)
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Olivier Olivier, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163732
- Sponsor's protocol ID
- ET16-115
- Acronym
- PROFILER 02
- Status last verified
- Mar 2022
- First submitted
- 17 May 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tredan O, Pouessel D, Penel N, Chabaud S, Gomez-Roca C, Delord JP, Pannier D, Brahmi M, Fabbro M, Garcia ME, Larrieu-Ciron D, Ray-Coquard I, Viala M, Italiano A, Tosi D, Cassier P, Dufresne A, Attignon V, Boyault S, Treilleux I, Viari A, Perol D, Blay JY. Broad versus limited gene panels to guide treatment in patients with advanced solid tumors: a randomized controlled trial. Nat Med. 2025 May;31(5):1502-1508. doi: 10.1038/s41591-025-03613-x. Epub 2025 Apr 7.
PubMed 40195451
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT03163732
- Acronym / sponsor ID
- PROFILER 02 / ET16-115
- Conditions
- Advanced Solid Tumor
- Keywords
- Solid tumor, Advanced tumor, Profiling panel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 23 May 2017 (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.
The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.
This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).
Detailed description
The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample.
For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given patient based on its molecular profile. First, the genomics data issued from the panel defined by the randomization will be reviewed and recommended therapy resulting from randomization will be revealed to the Investigator. If a recommended therapy can be identified, this therapy will be recommended.
If none recommended therapy can be identified, the 2nd panel performed will then be reviewed.
In case of confirmed clinical or radiological progression (at Investigator's discretion) and/or unacceptable toxicity as per Investigator judgment during the line of therapy recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other treatment options. All results will be disclosed to Investigator in order to offer other treatment options.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Arm A: Tumor-based genomics according to the 324 cancer-related genes Next Generation Sequencing (NGS) panel from Foundation One (FOne panel). * Arm B: Tumor-based genomics according to the 87 cancer-related genes NGS panel performed at Centre Leon Berard "Unité de Caractérisation Tumorale" (CONTROL panel). Both panels will be performed concomitantly for all patients using the same patient tumor specimen.
| Arm | Type | Receives |
|---|---|---|
| Large molecular profiling panel | Other | Genetic: Blood and tumor samplesThis panel is FOne Panel with a 324 cancer-related gene. |
| Limited molecular profiling panel | Other | Genetic: Blood and tumor samplesThis panel is CONTROL Panel with a 87 cancer-related gene. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female patient aged ≥ 18 years at time of inform consent signature.
- Currently treated by a first or a second line of chemotherapy for their advanced cancer (local relapse or metastatic; Immunotherapies, Endocrine therapies and Targeted therapies are not considered as a line of chemotherapy).
- Histologically confirmed diagnosis of advanced (local relapse or metastatic), incurable solid tumors from any histological types (except those listed in exclusion criteria 3).
- I4. Availability of an adequate tumor sample to be sent imperatively to the CLB within 15 days after ICF signature by order of preference either (i1) a tumor archival FFPE block not older than 3 months prior to ICF signature or if not available :(ii2) a dedicated biopsy from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm or if not feasible (3) an archival tumor sample (primary tumor or metastatic lesion) not older than 3 years at time of ICF signature. Quality (at least 20-30% of tumor cells) and quantity (sample size surface area > 5mm2 and > 90um depth) of the tumor sample have to be confirmed mandatorily within 7 days by a central pathological review before confirmation of inclusion.
- Patient's disease which is not susceptible to progress during the next 45 days following the ICF signature.
Key exclusion criteria (10 listed)
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
- Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate an anti-cancer treatment and its procedures (these conditions include but are not limited to severely impaired lung function, active gastrointestinal tract ulceration, acute or chronic uncontrolled liver disease/or severe renal disease, uncontrolled diabetes, history of HIV infection/or active viral infection (HBV, HCV), history of organ allograft or patient taking immunosuppressive treatment).
- Patient with the following advanced cancers :
- Patient with non assessable tumor sample.
- Patient already included in this study for a type of cancer, can't be included a second time for the same cancer or for any other type of cancer.
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 |
|---|---|---|
| Blood and tumor samplesAlso: Evaluation of the added value of a molecular profiling panelEvaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel | Genetic | Large molecular profiling panel, Limited molecular profiling panel |
Primary outcome
Compare the proportion of patients for whom a genomically identified recommended therapy could be initiated using the large NGS panel from FoundationOne versus the limited CONTROL panel.
Time frame: 28 months
10 secondary outcomes
Compare in the 2 randomization arms the number of patients with at least one actionable alteration.
Time frame: 28 months
Compare in the 2 randomization arms the proportion of patients for which a genomically identified recommended therapy is effectively initiated.
Time frame: 28 months
Describe in both arms the number of patients for whom a genomically identified recommended therapy was available but not initiated.
Time frame: 28 months
Evaluate proportion of patients who could have been initiated a recommended therapy considering only the INCa panel.
Time frame: 28 months
Progression-Free Survival (PFS)
Time frame: 24 months
Overall response Rate (ORR)
Time frame: 24 months
Duration of response (DoR)
Time frame: 24 months
Patient Quality Of Life
Time frame: 12 months
Perform a health economic evaluation
Time frame: 12 months
Perform a health economic evaluation
Time frame: 12 months
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 9 May 2022.
- Derived from this study: PubMed 40195451Tredan O, Pouessel D, Penel N, Chabaud S, Gomez-Roca C, Delord JP, Pannier D, Brahmi M, Fabbro M, Garcia ME, Larrieu-Ciron D, Ray-Coquard I, Viala M, Italiano A, Tosi D, Cassier P, Dufresne A, Attignon V, Boyault S, Treilleux I, Viari A, Perol D, Blay JY. Broad versus limited gene panels to guide treatment in patients with advanced solid tumors: a randomized controlled trial. Nat Med. 2025 May;31(5):1502-1508. doi: 10.1038/s41591-025-03613-x. Epub 2025 Apr 7.
- 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.
Olivier Olivier, MD principal investigator
Centre Leon Berard
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and tumor samples in people with Advanced Solid Tumor, run by Centre Leon Berard at 15 sites in France.
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 16 inclusion and 10 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
Compare the proportion of patients for whom a genomically identified recommended therapy could be initiated using the large NGS panel from FoundationOne versus the limited CONTROL panel. (time frame: 28 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163732, which also lists 1 linked publication.
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 9 May 2022.