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

Not Applicable

Recruiting

• Conditions: non-small cell lung cancer; non-small cell lung cancer, carcinoma, lung cancer, immune checkpoint inhibitor, immunotherapy; D002289

• Registration Number: JPRN-jRCT1021230030
• Lead Sponsor: Suzuki Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified