Clinical trial · Interventional
Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA
Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy. Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response. An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ctDNA analysis
- description
- additional blood sample of 20 ml
- interventionNames
- Other: ctDNA analysis
Primary outcomes (1)
- measure
- Biological response at week 3
- timeFrame
- week 3 after patient's recruitment date (baseline)
- description
- Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.
Secondary outcomes (4)
- measure
- Progression-free survival (radiological assessment) and biological response at week 3.
- timeFrame
- week 3 after baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or locally advanced non-small cell lung cancer (stage III or IV) * At least one measurable target according to RECIST criteria * Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management * Performance Status 0 to 2 * Affiliated to a social security system * Patient who can be followed under the protocol * Patient agreed to participate in the study and gave his/her express consent Exclusion Criteria: * Minor * Small cell or mixed bronchial cancer * Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days * Patient who has already started a first line of treatment * Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study * History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years * Patient which, does present a substantial risk of recurrence. * Major under guardianship, curators or deprived of liberty * Pregnant or lactating woman, or of childbearing age without effective contraception * Not affiliated to a social security system * Inability to understand the protocol and / or to give express consent
References
Publications (1)
- BACKGROUNDHerbreteau G, Marcq M, Sauzay C, Carpentier M, Pierre-Noel E, Pons-Tostivint E, Vallee A, Theoleyre S, Bizieux A, Bennouna J, Denis MG. Absolute Quantification of Nucleotide Variants in Cell-Free DNA via Quantitative NGS: Clinical Application in Non-Small Cell Lung Cancer Patients. Cancers (Basel). 2025 Feb 25;17(5):783. doi: 10.3390/cancers17050783. PMID 40075630