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Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer (Telocap02)

C

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Lung Cancer

Treatments

Other: Biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02846103
P/2013/207

Details and patient eligibility

About

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).

Enrollment

321 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

321 participants in 1 patient group

Biological samples
Experimental group
Description:
Blood samples will be collected at baseline, after the first-line therapy and at 12 months. Tumor tissues will be collected if available.
Treatment:
Other: Biological samples

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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