Inflammation, Cachexia and Therapeutic Response in Lung Cancer Treated With Immune Checkpoint Inhibitors: Exploratory Observational Study

NCT07004868 | Recruiting

• 1 other identifier: DR240341 - LCab
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer-related death in France and globally, with 2.48 million new cases diagnosed in 2022, accounting for nearly 13% of global cancer incidence. Despite recent advances, it remains a major health issue due to late-stage diagnosis and high patient and societal burden. New insights into tumor and immune pathways have led to the development of targeted therapies, including tyrosine kinase inhibitors and therapeutic antibodies. Among these, immune checkpoint inhibitors (ICIs) such as nivolumab, pembrolizumab, atezolizumab, and durvalumab have significantly improved outcomes for some patients by reactivating T-cell responses. The LCAb (Lung Cancer Antibodies) research project focuses on studying the interindividual variability of clinical response to ICI in lung cancer. These therapies are now used across various lung cancer types and stages, including early and advanced disease. Most ICIs are administered at fixed doses, without considering patient-specific factors as blood concentrations, tumor burden, body weight or nutritional status. The study hypothesizes that fixed dosing may affect treatment response and survival outcomes, highlighting the need for more personalized approaches.

Conditions

Lung Cancer (NSCLC)

Keywords

immune checkpoint inhibitors; inflammation; cachexia

Outcome Measures

Primary Outcomes (1)

• time to progression

  time between 1st administration of Ab ICI and progression or death from any cause.

  Month 36

Secondary Outcomes (5)

• weight

  from day 0 to month 36 at each patient visit

• Serum CRP concentration

  from day 0 to month 36 at each patient visit

• Serum Ab ICI concentration

  from day 0 to month 36 at each patient visit

• Drug toxicity

  from day 0 to month 36 at each patient visit

• Overall survival

  from day 0 to month 36 at each patient visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a lung cancer treated with immune checkpoint inhibitors

You may qualify if:

• Age greater than or equal to 18 years
• Diagnosis of lung cancer, any histology, any stage
• Treatment with Ab ICI, with or without chemotherapy
• st administration of Ab ICI

You may not qualify if:

• Patient not followed at the CHRU de Tours
• Person under protective supervision
• Opposition to data processing

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

university hospital, Tours

Tours, 37000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Inflammation; Cachexia

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Marion FERREIRA, Dr

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion FERREIRA, Dr

CONTACT

0247471640; marion.ferreira@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

FR (1)