Using liquid biopsy to predict responses to immunotherapy in metastatic lung cancer
LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer
This study is testing if measuring tumor DNA in the blood can help predict how well new immunotherapy treatments work for people with advanced lung cancer who haven't started treatment yet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab |
| Locations | 3 sites (Boulogne-Billancourt and 2 other locations) |
| Trial ID | NCT04790682 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the predictive value of circulating tumor DNA (ctDNA) levels in patients with metastatic non-small cell lung cancer (NSCLC) who are treatment-naïve and eligible for first-line immunotherapy. Patients will undergo next-generation sequencing (NGS) analysis on tumor tissue to identify mutations, and only those with at least one mutation will be enrolled. Blood samples will be collected at various intervals to monitor ctDNA levels and assess treatment response using RECIST 1.1 criteria. The study will also include routine imaging to evaluate disease progression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically-proven metastatic NSCLC who have not received prior treatment and are eligible for first-line immunotherapy.
Not a fit: Patients with ALK or EGFR gene alterations or those who are not treatment-naïve may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with metastatic lung cancer, improving their response to immunotherapy.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for monitoring treatment responses in various cancers, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boulogne-Billancourt and 2 other locations
- Hopital Ambroise Pare — Boulogne-Billancourt, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- Institut Curie — Saint-Cloud, France (Recruiting)
Study contacts
- Study coordinator: Marie-Emmanuelle Legrier
- Email: marieemmanuelle.legrier@curie.fr
- Phone: 01 56 24 56 49
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.