Clinical trial NCT02846103: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer
Official title: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: date of death from any cause (within 2 years after the initiation of the treatment)
Secondary outcomes:
measure: UCP-specific Th1 responses measured by ELISPOT assay
timeFrame: up to 12 months
measure: Progression free survival
timeFrame: date of first progression of the disease (within 2 years after the initiation of the treatment)
measure: quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.
timeFrame: from the inclusion to patient death, up to 2 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Dijon
country: France
facility: CHU de Dijon
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Reims
country: France
facility: Institut Jean Godinot
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References:
citation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillere B, Tartour E, Borg C, Adotevi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.
citation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619. doi: 10.4161/onci.21513.