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

NCT02846103 | Completed

• 1 other identifier: P/2013/207
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 5

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).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• quality of life related to health measured by EORTC-QLQC30 and LC13 questionaries.

  from the inclusion to patient death, up to 2 years

Study Arms (1)

Biological samples

EXPERIMENTAL

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

Interventions

Biological samples OTHER

blood and tumor tissue samples

Biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (5)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

CHU de Dijon

Dijon, 21079, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Institut Jean Godinot

Reims, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Related Publications (2)

• 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.

  PMID: 22407833 BACKGROUND

• 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.

  PMID: 23264913 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 27, 2016
• Study Start: December 1, 2015
• Primary Completion: July 27, 2022
• Study Completion: September 14, 2023
• Last Updated: September 18, 2023

Record last verified: 2022-05

Locations

FR (5)