臨床研究等提出・公開システム

Multicenter Study to Evaluate the Usefulness of TCR Repertoire as a Prognostic Marker in Postoperative Adjuvant Atezolizumab for Non-Small Cell Lung Cancer (SEATRAIN)

Multicenter Study to Evaluate the Usefulness of TCR Repertoire as a Prognostic Marker in Postoperative Adjuvant Atezolizumab for Non-Small Cell Lung Cancer (SEATRAIN)

Suzuki Hiroyuki

Fukushima Medical University

Hikarigaoka 1, Fukushima city, Fukushima

hiro@fmu.ac.jp

Muto Satoshi

Fukushima Medical University

Hikarigaoka 1, Fukushima city, Fukushima

+81-24-547-1252

smutoo@fmu.ac.jp

Recruiting

Oct. 31, 2023

Observational

single arm study

open(masking not used)

uncontrolled control

single assignment

other

(1) Patients must be at least 18 years of age at the time of consent.
(ii) Patients with a clinical diagnosis of c-stage I-III non-small cell lung cancer that can be completely resected and who will undergo surgery
(iii) Patients with performance status 0-1 judged by physician to be tolerant to postoperative adjuvant chemotherapy including cisplatin
(iv) Patients judged by physician to be tolerant of adjuvant atezolizumab therapy.
(v) Patients who have consented to participate in this study
(vi) Patients whose postoperative pathology diagnosis is p-stage II-IIIA and who have been treated with atezolizumab as adjuvant therapy will be included in the analysis.
(7) Patients who fulfill the above conditions and newly consent to this study among those who have collected and stored peripheral blood mononuclear cells and tumor-infiltrating lymphocytes prior to surgery in a previous study (Ethics Committee approval number: General 30163) will also be included.

(i) Pregnant or lactating women
(ii) Patients with a history of interstitial lung disease or pulmonary inflammation
(iii) Patients with active autoimmune diseases
(iv) Patients with postoperative pathological diagnosis other than p-stage II-IIIA
5) Patients with positive postoperative residual disease
(vi) Patients with PD-L1 TPS<1% (regardless of the type of anti-PD-L1 antibody used for immunostaining)
(vii) Patients who did not receive postoperative adjuvant therapy with atezolizumab

Both

non-small cell lung cancer

non-small cell lung cancer, carcinoma, lung cancer, immune checkpoint inhibitor, immunotherapy

D002289

Association of clonal changes in TCR repertoire in peripheral blood T cells during postoperative adjuvant therapy with atezolizumab for non-small cell lung cancer with 2-year disease-free survival

1) The association between the increase in peripheral blood T-cell clones with TCR repertoires consistent with tumor-infiltrating lymphocytes during postoperative adjuvant therapy with atezolizumab for non-small cell lung cancer and 2-year disease-free survival.
2) Association between clonality of peripheral blood TCR repertoire prior to surgery and initiation of treatment with atezolizumab and 2-year disease-free survival.

+81-24-547-1825

Aug. 15, 2023

none