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

JRCT ID: jRCT1021230030

Registered date:31/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 26/12/2023
• Target sample size: 20
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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

Related Information

• Primary Sponsor: Suzuki Hiroyuki
• Source(s) of Monetary Support: Chugai Pharmaceutical Co., Ltd.