Using liquid biopsy to predict responses to immunotherapy in metastatic lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.