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

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Lung Cancer

Treatments

Other: Biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02846103

P/2013/207

Details and patient eligibility

About

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).

Enrollment

321 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.