Adjuvant therapy in pathological stage IA2-IIA EGFR-mutated NSCLC: a multicenter prospective observational study

UMIN ID: UMIN000054291

Registered date:07/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: non-small cell lung cancer(non-squamous cell cancer)
• Date of first enrollment: 2024/05/07
• Target sample size: 800
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Disease-free survival

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Cases that fall under any of the following items will be excluded. 1) Have active multiple cancers*1 2) Have a local or systemic active infection that requires treatment 3) Pregnant women, lactating women, and women who may be currently pregnant. 4) Registration in this study is judged to be difficult due to a clinically problematic mental illness. 5) Receiving continuous systemic administration of steroids or immunosuppressants 6) Have a history of severe hypersensitivity 7) Exclusion provisions regarding complications (a) Have a history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or have active ILD. (b) Viral hepatitis HBs antigen positive or HCV antibody positive (c) HIV positive (however, negative confirmation by serum test is not required). 8) Other cases deemed inappropriate by the attending physician

Related Information

• Primary Sponsor: National Cancer Center
• Source(s) of Monetary Support: Astrazenaca
• Secondary ID(s): WJOG17123L