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NCT Number: NCT02846103

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

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).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional Universitaire de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological Samples

Other

blood and tumor tissue samples

Primary outcomes

  1. 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

Secondary outcomes

  1. UCP-specific Th1 responses measured by ELISPOT assay

    Time frame: up to 12 months

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: Telocap02

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Jul 27, 2016
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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