This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.
This study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage IA-IB) non-small cell lung cancer (NSCLC) who have undergone complete surgical resection but are at high risk of recurrence. Based on each patient's specific driver gene mutation status (e.g., EGFR or ALK/ROS1) or wild-type status, participants will receive either targeted therapy or immunotherapy compared to routine follow-up (observation). The goal is to see if these approaches can improve disease-free survival and potentially reduce the risk of lung cancer recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Oral icotinib tablets (125 mg) administered three times daily (TID) for up to 1 year or until disease recurrence or unacceptable toxicity. Icotinib is an EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing mutations.
Oral rezivertinib capsules (100 mg) taken once daily (QD) for up to 1 year or until disease recurrence or unacceptable toxicity. Rezivertinib is an EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing mutations.
Oral ensartinib capsules (225 mg) taken once daily (QD) for up to 1 year or until disease recurrence or unacceptable toxicity. Ensartinib is an ALK/ROS1 tyrosine kinase inhibitor designed to inhibit ALK/ROS1 fusion-driven NSCLC.
Disease-Free Survival (DFS)
Disease-free survival (DFS) is defined as the time from randomization to the first documented disease recurrence (local relapse or distant metastasis confirmed by imaging or pathology) or death from any cause, whichever occurs first. Participants without documented recurrence or death at the time of analysis will be censored at their last disease assessment date.
Time frame: From randomization until disease recurrence or death (up to approximately 5 years)
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who remain alive or are lost to follow-up at the time of analysis will be censored at the date of last contact.
Time frame: From randomization to death or last follow-up (up to approximately 5 years)
Central Nervous System Disease-Free Survival (CNS DFS)
CNS DFS is defined as the time from randomization to the date of first occurrence of central nervous system (CNS) metastases or death from any cause, whichever occurs first, as determined by imaging or clinical assessment. Participants without a CNS event or death at the time of analysis will be censored at their last disease assessment date.
Time frame: From randomization until CNS progression or death, whichever occurs first (up to approximately 5 years)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
AEs graded by CTCAE version 5.0
Time frame: From date of randomization up to approximately 5 years
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Intravenous infusion of bemosumab 1200 mg every 3 weeks (Q3W). Treatment continues for up to 4 cycles initially, and may be extended (maintenance) for up to 3 years or until disease recurrence or unacceptable toxicity. Bemosumab is a monoclonal antibody under investigation for immunotherapy in NSCLC.