Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer (Telocap02)

September 15, 2023 updated by: Centre Hospitalier Universitaire de Besancon

Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France
        • Centre Hospitalier Régional Universitaire de Besançon
      • Dijon, France
        • Centre Georges François Leclerc
      • Dijon, France, 21079
        • CHU de Dijon
      • Reims, France
        • Institut Jean Godinot
      • Strasbourg, France
        • Hôpitaux universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)
  • stade IIIb or metastatic
  • Patient candidate to a first-line therapy
  • Performance status 0, 1 or 2 on the ECOG scale
  • Written informed consent

Exclusion Criteria:

  • History of adjuvant chemotherapy for lung cancer treatment
  • Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
  • Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
  • Active autoimmune diseases, HIV, hepatitis C or B virus
  • Patients with any medical or psychiatric condition or disease,
  • Patients under guardianship, curatorship or under the protection of justice.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological samples

Blood samples will be collected at baseline, after the first-line therapy and at 12 months.

Tumor tissues will be collected if available.
Other: Biological samples
blood and tumor tissue samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: date of death from any cause (within 2 years after the initiation of the treatment)
time between the date of initiation of treatment and the date of death from any cause
date of death from any cause (within 2 years after the initiation of the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UCP-specific Th1 responses measured by ELISPOT assay
Time Frame: up to 12 months
up to 12 months
Progression free survival
Time Frame: date of first progression of the disease (within 2 years after the initiation of the treatment)
time interval between the date of initiation of treatment and the date of first progression (local, remote [extent of the disease by RECIST v1.1] second cancer) or death from any cause.
date of first progression of the disease (within 2 years after the initiation of the treatment)
quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.
Time Frame: from the inclusion to patient death, up to 2 years
from the inclusion to patient death, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

July 27, 2022

Study Completion (Actual)

September 14, 2023

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimated)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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