Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT02846103
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- 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
Centre Hospitalier Régional Universitaire de Besançon🇫🇷Besançon, France