LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG
Recruiting · NCT04790682 · Interventional (participants receive a specific treatment) · Lead sponsor: Institut Curie
View the official record on ClinicalTrials.gov →Interventions studied
assessment of the predictive value of ctDNA level of the prominent mutant allele variation between baseline and week 6, on response to treatment according to RECIST 1.1 criteria.
What this trial is about
Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically-proven NSCLC.
- Age ≥ 18 years.
- Advanced or metastatic stage IV.
- Treatment-naïve patient.
- Eligibility to first-line treatment with immune checkpoint inhibitor.
- Measurable disease according to RECIST 1.1 criteria on CT-Scan.
- Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy.
- No ALK or EGFR gene alteration.
- Availability of tumor tissue for NGS analysis (7 slides).
- PS 0 or 1.
- Signed informed consent of the patient.
Exclusion criteria
- No social security affiliation.
- Person under legal protection.
- Pregnant and breastfeeding women.
- Patients can participate to another clinical trial that is not modifying immunotherapy or immunotherapy/chemotherapy treatment nor study follow-up ; after investigator's information
Where it is running
3 locations listed.
- Hopital Ambroise Pare - Boulogne-Billancourt, France
- Institut Curie - Paris, France
- Institut Curie - Saint-Cloud, France