Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
IC 2020-02
- NCT ID:
NCT04790682
Conditions
- NSCLC Patient in a Metastatic Stage Eligible for First-line Treatment With Immune Checkpoint Inhibitor
Interventions
| Drug | Synonyms | Arms |
|---|
| 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. | | NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor. |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| NSCLC patient in a metastatic stage eligible for 1st-line TT with immune checkpoint inhibitor. | Experimental | | - 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.
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | ctDNA variation of the prominent mutant allele variation |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | ctDNA variation of the prominent mutant allele variation between baseline and week 6, 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 Outcome Measures
| Measure: | ctDNA variation of the prominent mutant allele variation |
| Time Frame: | 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. |
| Safety Issue: | |
| Description: | ctDNA variation of the prominent mutant allele variation between baseline and week 6, 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: | Progression-free survival |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Progression-free survival according to immune cell levels in the blood |
| Measure: | Overall survival |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Overall survival according to immune cell levels in the blood |
| Measure: | Progression-free survival |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Progression-free survival according to immune cell levels variations in the blood |
| Measure: | Overall survival |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Overall survival according to immune cell levels variations in the blood |
| Measure: | Progression-free |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Progression-free survival according to ctDNA level variations. |
| Measure: | Overall survival |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Overall survival according to ctDNA level variations. |
| Measure: | Response rate to the second line of treatment |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Response rate to the second line of treatment based on RECIST 1.1 and iRECIST criteria according to ctDNA level at week 6 of the second line of treatment. |
| Measure: | Adverse events of special interest |
| Time Frame: | 6 weeks after progression after first-line treatment or a maximum of 21 months |
| Safety Issue: | |
| Description: | Adverse events of special interest of grade 3 or more (CTCAE v5.0). |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Institut Curie |
Trial Keywords
- Lung Cancer NSCLC
- metastatic stage
- first-line treatment with immune checkpoint inhibitor
Last Updated
July 13, 2021
