Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers

NCT ID: NCT05091190

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2026-12-11

Brief Summary

Immunotherapy is widely administrated as anticancer treatment in metastatic setting. Despite a proved efficacy in several cancer types and clinical situations, it exists a wide variability of responses in terms of efficacy and toxicity. The rate of responders depends mostly on the type of pathology, with 40% of responders among melanoma patients, 20-30% among lung and head and neck cancer patients and only 1% of responders among pancreatic cancer patients. Thus, the main challenge today is to be able to select patients for whom the treatment is likely to be effective. Several studies suggested that tumors with a high mutational burden and expressing PD-L1 are better responders to immunotherapy.

However, a proportion of PD-L1 negative cancers responds to immunotherapy, suggesting that other parameters have to be considered together with PD-L1 expression. Of that, the immunotherapy clearance seems to have an impact on overall survival, but larger studies, including different molecules and cancer types, are needed to better understand the correlation between the clearance and the response to immunotherapy.

Tumor cells released from the primary tumor in the blood circulation (CTCs, for circulating tumor cells) are considered as "liquid biopsies", as they contain the entire genetic and phenotypic information representative of the tumor, including PD-L1 expression. Thus, the variation of PD-L1 expression under treatment can be easily followed-up on blood samples collected during the time.

The objective of MADMAS is to study the correlation between the immunotherapy clearance, measured at the different times during treatment, and the variation of the number of CTCs expressing PD-L1 after two cures of treatment.

MADMAS will enroll patients with lung or head and neck cancers, treated with an immunotherapy-based therapy. Blood samples will be collected at the baseline and before the first two cures of treatment. The immunotherapy clearance will be measured with an innovative approach of Mass Spectrometry, and PD-L1 expression will be measured on CTCs, purified with a highly sensitive microfluidics technology.

Conditions

Metastatic NSCLC; Metastatic Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

cancer patients

MADMAS will include 30 patients with metastatic NSCLC and 30 patients with metastatic head and neck cancers; patients will NSCLC will receive an immunotherapy-based treatment in first line metastatic setting; patients with head and neck cancers are included if they are planned to receive an immunotherapy-based treatment, whatever the line.

Group Type: OTHER

Blood draws

Intervention Type: OTHER

Blood draws will be realized at the following time points:

C1T1: at the baseline, before treatment administration. C1T2: cycle 1, after treatment administration. C2T1: the day of the 2nd cycle, before treatment administration. C2T2: the day of 2nd cycle, after treatment administration. C3T1: the day of the 3rd cycle, before treatment administration. C3T2: the day of 3rd cycle, after treatment administration.

Interventions

Blood draws

Blood draws will be realized at the following time points:

C1T1: at the baseline, before treatment administration. C1T2: cycle 1, after treatment administration. C2T1: the day of the 2nd cycle, before treatment administration. C2T2: the day of 2nd cycle, after treatment administration. C3T1: the day of the 3rd cycle, before treatment administration. C3T2: the day of 3rd cycle, after treatment administration.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Lung cancer (n= 30):

• Adult patients
• Patients who gave its written informed consent to participate to the study
• Weight at inclusion ≥ 48 kg
• NSCLC histology only
• Stage IV according to 8th TNM classification
• Planned to be treated with immunotherapy (+/- chemotherapy) as a first line treatment in metastatic setting
• PD-L1 status on primary tumor available at the inclusion
• Patients affiliated to a social insurance regime

Head and neck cancer (n= 30):

• Adult patients
• Patients who gave its written informed consent to participate to the study
• Weight at inclusion ≥ 48 kg
• Recurrent or metastatic epidermoid carcinomas from oral cavity, oropharynx, hypopharynx, larynx (except nasopharynx)
• Stage IV according to 8th TNM classification
• Planned to be treated with immunotherapy (+/- chemotherapy)
• PD-L1 status on primary tumor available at the inclusion
• Patients affiliated to a social insurance regime

Exclusion Criteria

• History of previous cancers, except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, treated and with no evidence of disease for ≥ 5 years
• Patients under tutorship or guardianship
• Pregnant or breast feeding women
• Patients under psychiatric care

• Patients already treated with immunotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre PHILOUZE, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Croix Rousse Hospital

Lyon, , France

Lyon Sud Hospital

Pierre-Bénite, , France

Countries

France

Other Identifiers

2021-A01482-39

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL21_0458

Identifier Type: -

Identifier Source: org_study_id