Evaluation of the Added Value of a Large Molecular Profiling Panel Versus a Limited Molecular Profiling Panel in Advanced Solid Tumors.

NCT03163732 | Completed DMC

• 1 other identifier: ET16-115
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 15

Brief 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. 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).

Conditions

Advanced Solid Tumor

Keywords

Solid tumor; Advanced tumor; Profiling panel

Outcome Measures

Primary Outcomes (1)

• 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.

  28 months

Secondary Outcomes (10)

• Compare in the 2 randomization arms the number of patients with at least one actionable alteration.

  28 months

• Compare in the 2 randomization arms the proportion of patients for which a genomically identified recommended therapy is effectively initiated.

  28 months

• Describe in both arms the number of patients for whom a genomically identified recommended therapy was available but not initiated.

  28 months

• Evaluate proportion of patients who could have been initiated a recommended therapy considering only the INCa panel.

  28 months

• Progression-Free Survival (PFS)

  24 months

Study Arms (2)

Large molecular profiling panel

OTHER

This panel is FOne Panel with a 324 cancer-related gene.

Genetic: Blood and tumor samples

Limited molecular profiling panel

OTHER

This panel is CONTROL Panel with a 87 cancer-related gene.

Genetic: Blood and tumor samples

Interventions

Blood and tumor samples GENETIC

Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel

Also known as: Evaluation of the added value of a molecular profiling panel

Large molecular profiling panel; Limited molecular profiling panel

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• 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 :

Sponsors & Collaborators

• Centre Leon Berard: lead
• Roche Pharma AG: collaborator

Study Sites (15)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Jean PERRIN

Clermont-Ferrand, France

Location

Centre Georges François LECLERC

Dijon, France

Location

Centre Oscar Lambret

Lille, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

AP-HM MARSEILLE - Hôpital Nord

Marseille, 13915, France

Location

Institut cancer Montpellier - ICM

Montpellier, France

Location

Institut Curie

Paris, 75231, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Eugène Marquis

Rennes, France

Location

ICO site René Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancérologie Lucien NEUWIRTH

Saint-Priest-en-Jarez, 422270, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 40195451 DERIVED

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olivier Olivier, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: * 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.

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 23, 2017
• Study Start: June 29, 2017
• Primary Completion: November 23, 2021
• Study Completion: November 23, 2021
• Last Updated: May 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)