Tumor Mutational Burden in Lung Cancer Patients

NCT04289259 | Terminated

• 3 other identifiers: APHP1800232019-A00129-48CA209-8RK
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 8

Brief Summary

Tumor mutational burden (TMB) seems to be is an important marker for immune checkpoint inhibitors efficacy. This study aims to assess the feasibility of the TMB assessment in first-line lung cancer in routine practice both on biopsy and surgical tumor samples. Results will be an element of discussion for the generalization of the TMB implementation in cancer centers.

Conditions

Non Small Cell Lung Cancer; Non-Small Cell Carcinoma of Lung; Non Small Cell Lung Cancer Stage III; Non-small Cell Lung Cancer Stage IV

Keywords

Tumor mutational burden; Cancer gene panel; Whole-exome sequencing; FoundationOne CDx assay panel; RNA-sequencing

Outcome Measures

Primary Outcomes (1)

• Global attrition rate

  Number of cases without result

  Time of sample analysis

Secondary Outcomes (7)

• Turnaround time to determine tumor mutational burden (TMB)

  3 weeks

• Attrition rate for RNA-sequencing (RNAseq)

  Time of sample analysis

• Rate of misclassification for TMB determined by RNA-seq

  Time of sample analysis

• Rate of misclassification for TMB determined by Cancer Genome Panel (CGP)

  Time of sample analysis

• Rate of misclassification for TMB determined by FoundationOne CDx assay panel

  Time of sample analysis

Study Arms (3)

Biopsy sample

Tumor mutational burden (TMB) will be assessed on a sample of the biopsy done during standard care of patients.

Other: TMB assessment

Surgical sample

TMB will be assessed on a sample of the tumor surgical specimen resected during standard care of patients.

Other: TMB assessment

Biopsy sample + surgical sample

TMB will be assessed both on a sample of the biopsy and a sample of the tumor surgical specimen resected during standard care of patients.

Other: TMB assessment

Interventions

TMB assessment OTHER

Tumor mutational burden could be calculated by cancer gene panel (CGP), whole-exome sequencing (WES), RNA-sequencing (RNA-seq), FoundationOne CDx assay panel (FMI).

Biopsy sample; Biopsy sample + surgical sample; Surgical sample

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with a non-small cell lung cancer (NSCLC) and naive of treatment

You may not qualify if:

• Patient age will be ≥ 18 years old and \< 85 years old
• The pre-analytical features of the patient's sample are compatible with the CGP / WES analysis.
• Patient has signed the ICF.
• The FFPE material from the patient's sample needs to be available to be analyzed on site and sent for central analyses. If FFPE sample is not available within 1 month, on-site analysis can begin on extracted DNA previously screened in small panel NGS.
• The neoplastic cells in the patient's sample should be superior to 30%.
• The TMB in patient's NSCLC is already known or estimated in the case of a clinical trial.
• Patient with relapsing NSCLC if the initial cancer has received a neoadjuvant / adjuvant treatment.
• Patient under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Bristol-Myers Squibb: collaborator

Study Sites (8)

Centre Jean Perrin

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63000, France

Location

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France

Location

Institut Bergonié

Bordeaux, Nouvelle-Aquitaine, 33000, France

Location

Institut Curie

Paris, Île-de-France Region, 75005, France

Location

AP-HP - Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Location

AP-HP - Hôpital Européen Georges-Pompidou

Paris, Île-de-France Region, 75015, France

Location

AP-HP - Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

20 ml of blood samples will be collected to reach 10 ml of plasma

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jacques Cadranel, MD

  AP-HP - Hôpital Tenon

  PRINCIPAL INVESTIGATOR

• Benjamin Besse, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

• Pierre Laurent-Puig, MD

  AP-HP - Hôpital Européen Georges-Pompidou

  STUDY DIRECTOR

• Etienne Rouleau, PharmD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: June 10, 2020
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.

Locations

FR (8)