Clinical trial · Observational
Tumor Mutational Burden in Lung Cancer Patients
National Real-life Study of Tumor Mutational Burden Assessment in First-line Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The funder stopped to fund this study.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Carcinoma of Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non Small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TMB assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Biopsy sample
- description
- Tumor mutational burden (TMB) will be assessed on a sample of the biopsy done during standard care of patients.
- interventionNames
- Other: TMB assessment
- label
- Surgical sample
- description
- TMB will be assessed on a sample of the tumor surgical specimen resected during standard care of patients.
- interventionNames
- Other: TMB assessment
- label
- Biopsy sample + surgical sample
- description
- 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.
- interventionNames
- Other: TMB assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available