Clinical trial NCT04790682: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG
Official title: LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Lung Cancer
Keywords: Lung Cancer NSCLC
metastatic stage
first-line treatment with immunotherapy
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: A pre-screening consent will be obtained for NGS analysis on tumor tissue. Only patients with at least 1 mutation at NGS on the tumor tissue will ultimately be enrolled in the study, to have the possibility to follow the mutation using ctDNA. Main consent will be obtained after results of the NGS and before initiation of pembrolizumab. Computed Tomography (CT)-scan imaging will be done every 9 weeks as part of routine care practice. Blood specimens will be taken with EDTA tubes or streck tubes at the time of puncture for pembrolizumab infusion at baseline before starting treatment, at 3 weeks, 6 weeks and then every 6 weeks. Blood immunomonitoring will be done before starting the treatment, at 6 weeks and at 18 week. An additional measurement will be performed if treatment is stopped before the end of the study.

- Optional blood samples will be realized to analyse the degree of activity of the plasmatic lymphocytes.

Eligibility criteria: Inclusion Criteria:

1. Histologically-proven NSCLC.
2. Age ≥ 18 years.
3. Advanced or metastatic stage IV.
4. Treatment-naïve patient.
5. Eligibility to first-line treatment with immune checkpoint inhibitor.
6. Measurable disease according to RECIST 1.1 criteria on CT-Scan.
7. Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy.
8. No ALK or EGFR gene alteration.
9. Availability of tumor tissue for NGS analysis (7 slides).
10. PS 0 or 1.
11. Signed informed consent of the patient.

Exclusion Criteria:

1. No social security affiliation.
2. Person under legal protection.
3. 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

Primary outcomes:
measure: ctDNA variation of the prominent mutant allele variation
timeFrame: 6 weeks on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on RECIST 1.1 criteria
Secondary outcomes:
measure: ctDNA variation of the prominent mutant allele variation
timeFrame: 6 weeks on response to treatment defined as the proportion of patients who will achieve a complete or partial response at CT-scan based on iRECIST criteria.
measure: Free survival
timeFrame: End of study
measure: Overall survival
timeFrame: End of study
measure: Survival (FS)
timeFrame: End of study
measure: Survival (OS)
timeFrame: End of study
measure: Progression-free
timeFrame: End of study
measure: Survival
timeFrame: End of study
measure: Response rate to the second line of treatment
timeFrame: End of study
measure: Adverse events of special interest
timeFrame: End of study
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare
city: Paris
country: France
facility: Institut Curie
city: Saint-cloud
country: France
facility: Institut Curie
Study officials:
affiliation: INSTITUT CURIE - Medical Oncology
name: Nicolas GIRARD, PR
role: STUDY_DIRECTOR
affiliation: INSTITUT CURIE - Medical Oncology
name: Pierre FUMOLEAU
role: STUDY_CHAIR
References: