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

Study Overview
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Brief Summary
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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).

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Biological samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biological samples<br>Blood samples will be collected at baseline, after the first-line therapy and at 12 months. Tumor tissues will be collected if available. | Other: Biological samples<br>* blood and tumor tissue samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | time between the date of initiation of treatment and the date of death from any cause | date of death from any cause (within 2 years after the initiation of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UCP-specific Th1 responses measured by ELISPOT assay |  | 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. | 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. |  | from the inclusion to patient death, up to 2 years |