Prospective multicenter observational study of adjuvant atezolizumab in resected non-small-cell lung cancer

JRCT ID: jRCT1031220647

Registered date:17/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 03/04/2023
• Target sample size: 600
• Study type: Observational

Outcome(s)

• Primary Outcome: 3-year disease-free survival rate

Secondary Outcome

(1) DFS
(2) Disease-free survival rate
(3) OS
(4) Recurrence site
(5) Incidence rate of Adverse Events
(6) irAE incidence rate
(7) the following items for subgroup analysis
1) sex
2) age at the time of consent
3) ECOG PS
4) smoking history
5) histological type
6) preoperative clinical stage and postoperative pathological stage
7) prescribed regimen of postoperative adjuvant chemotherapy
8) administrated cycle number of postoperative adjuvant chemotherapy
9) completion or discontinuation of Atezolizumab treatment
10) PD-L1 status
11) with or without irAE onset
12) driver mutation
13) Other by patient background

Key inclusion & exclusion criteria

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

Include criteria

1) Patients 18 years of age or older at the time of written consent.
2) Patients with PD-L1 positive non-small cell lung cancer who had received complete resection and are scheduled to receive atezolizumab adjuvant therapy in clinical practice, based on the atezolizumab package insert and the Optimal Use Promotion Guideline.
3) Patients who had received appropriate explanation about the study and was willing to give written consent.

• Exclude criteria: 1) Patients who are unsuitable for enrolment into the study by the investigator's judgment.

Related Information

• Primary Sponsor: Ikeda Norihiko
• Source(s) of Monetary Support: A non Profit organization The Japan Lung Cancer Society