Lung Cancer
Conditions
Brief summary
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).
Interventions
OTHERBiological samples
blood and tumor tissue samples
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 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
| Measure | Time frame | Description |
|---|---|---|
| UCP-specific Th1 responses measured by ELISPOT assay | up to 12 months | — |
| Progression free survival | 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. |
| quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries. | from the inclusion to patient death, up to 2 years | — |
Countries
France
Outcome results
None listed