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RecruitingNCT07004868LCabUpdated Aug 11, 2025

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

An observational study in Lung Cancer (NSCLC), sponsored by University Hospital, Tours. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by University Hospital, Tours · Observational

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Lung cancer is the leading cause of cancer-related death in France and worldwide. Its incidence is significant, with 2.48 million new cases diagnosed in 2022, representing nearly 13% of the total global cancer incidence. Despite recent therapeutic advances, it remains a major public health issue due to its frequent diagnosis at a metastatic stage, which results in high morbidity and mortality for patients and significant costs for society.

A better understanding of tumor and immune signaling pathways has recently led to the discovery of new molecular targets, such as immune checkpoints. The therapeutic arsenal against lung cancer has thus expanded to include new molecules such as tyrosine kinase inhibitors and therapeutic antibodies (Abs). The latter represent the majority of anticancer biotherapies, with more than 50 approved agents for solid or hematologic cancers.

In particular, antibodies targeting immune checkpoints (ICIs - immune checkpoint inhibitors), such as nivolumab, pembrolizumab, atezolizumab, and durvalumab, have revolutionized the management of certain lung cancer patients by reversing T-cell exhaustion, allowing some of them to become long-term responders.

The research project "Pharmacokinetics of Immune Checkpoint Inhibitor Antibodies Used in Lung Cancer" (LCAb - Lung Cancer Antibodies) aims to study the blood concentrations and pharmacokinetics of various ICI-type antibodies used in the treatment of lung cancer.

Lung cancer is characterized by multiple histological types, stages, and molecular profiles, each associated with different therapeutic options. ICI-type antibodies have numerous indications in lung cancer, and these indications have continued to expand in recent years. They are now used not only in metastatic stages but also in localized and locally advanced stages. These molecules have led to a marked improvement in the prognosis of lung cancer patients. However, their effectiveness varies from one patient to another.

The study focuses on anti-PD-1 and anti-PD-L1 ICI antibodies used routinely in lung cancer, regardless of histology or stage, whether administered alone or in combination with chemotherapy. Most of these antibodies are administered at a fixed dose, without adjustment for age, weight, general health, or nutritional status of the patients.We hypothesize that the use of fixed-dose ICIs in lung cancer may influence therapeutic response and patient survival.

02

Conditions studied

  • Lung Cancer (NSCLC)

Keywords

  • immune checkpoint inhibitors
  • inflammation
  • cachexia
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In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with a lung cancer treated with immune checkpoint inhibitors

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age greater than or equal to 18 years
  • Diagnosis of lung cancer, any histology, any stage
  • Treatment with Ab ICI, with or without chemotherapy
  • 1st administration of Ab ICI

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. time to progression

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

    Time frame: Month 36

Secondary outcomes

  1. weight

    Time frame: from day 0 to month 36 at each patient visit

  2. Serum CRP concentration

    Time frame: from day 0 to month 36 at each patient visit

  3. Serum Ab ICI concentration

    measured using validated ELISA (Enzyme-Linked Immunosorbent Assay) techniques

    Time frame: from day 0 to month 36 at each patient visit

  4. Drug toxicity

    Time frame: from day 0 to month 36 at each patient visit

  5. Overall survival

    time between first administration of Ab ICI and death from any cause.

    Time frame: from day 0 to month 36 at each patient visit

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07004868
Responsible party
Sponsor
First posted
Jun 4, 2025
Start date
Jun 3, 2025
Primary completion
Jun 2030 (estimated)
Completion
Jun 2030 (estimated)
Last update
Aug 11, 2025

Study contacts

Marion FERREIRA, Dr
Contact
marion.ferreira@chu-tours.fr
0247471640 ext. +33
Marion FERREIRA, Dr
principal investigator · University Hospital, Tours

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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