LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cel
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.
| Condition(s) | Metastatic Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ; af |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Institut Curie |
| Locations | Boulogne-Billancourt, France; Paris, France; Saint-Cloud, France |
| Start date | 2021-05-22 |
| NCT ID | NCT04790682 |
| Official listing | https://clinicaltrials.gov/study/NCT04790682 |