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

Centre Hospitalier Universitaire de Besancon321 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

321

Conditions

Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

CHU de Dijon

Dijon, France

Centre Georges François Leclerc

Dijon, France

Institut Jean Godinot

Reims, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Outcomes

Primary Outcomes

overall survival

time between the date of initiation of treatment and the date of death from any cause

Time frame: date of death from any cause (within 2 years after the initiation of the treatment)

Secondary Outcomes

UCP-specific Th1 responses measured by ELISPOT assay

Time frame: up to 12 months

Progression free survival

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.

Time frame: 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