Molecular Monitoring of cfDNA by ddPCR in Non-small Cell Lung Cancer Treated by Immunotherapy.

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: IMMUNOTHERAPY; QUANTIFICATION OF CELL-FREE DNA; NSCLC

Treatments: Genetic: Molecular monitoring by quantification of cell-free DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT04720339

7652

Details and patient eligibility

About

Non-small cell lung cancer (NSCLC) is a major public health problem. New treatments as immunotherapy can improve prognosis of patients with NCLC tumors. Nevertheless, no robust biomarker is actually available.

The hypothesis of the trial is to realize a longitudinal molecular monitoring of NSCLC patients treated by immunotherapy using a quantitative analysis of cell-free DNA.

The primary purposes is to study the predictive value of quantification of cell-free DNA at the first reevaluation time, on the clinical benefit, in NSCLC patients treated by immunotherapy (regardless of line, or associated treatments) The secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free DNA, and its relationship with refractory disease and pseudo-progressive disease.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18
• informed of the objectives of the project and signed consent
• non small cell lung cancer, stage IIIA, IIIB or IV
• PS (WHO performance status) < or =2
• treatment based on immunotherapy (monotherapy or combination)
• at least one measurable target
• available results of PD-L1 expression

Exclusion criteria

• concomitant other type of cancer
• another cancer in the last 5 years

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Experimental arm

Experimental group

Treatment:

Genetic: Molecular monitoring by quantification of cell-free DNA