Status:
TERMINATED
Tumor Mutational Burden in Lung Cancer Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non Small Cell Lung Cancer
Non-Small Cell Carcinoma of Lung
Eligibility:
All Genders
18-85 years
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...
Detailed Description
1. Current knowledge about the field under investigation Clinical evidence demonstrates that treatment with immune checkpoint blocker (ICB) agents benefit to patients across multiple tumor type. H...
Eligibility Criteria
Inclusion
- Patient with any NSCLC, stage III and IV with a molecular analysis on the French platform. There will be no exclusion criteria on the presence of an oncogenic mutation as EGFR, KRAS, ALK.
- 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%.
Exclusion
- 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
Key Trial Info
Start Date :
June 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04289259
Start Date
June 10 2020
End Date
July 6 2020
Last Update
June 24 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 63000
2
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France, 69008
3
Institut Bergonié
Bordeaux, Nouvelle-Aquitaine, France, 33000
4
Institut Curie
Paris, Île-de-France Region, France, 75005