This multicenter, retrospective cohort study plans to enroll patients with lung adenocarcinoma who received neoadjuvant immunotherapy prior to surgery and did not achieve pathological complete response (non-pCR) upon postoperative pathological evaluation. Using Deoxyribonucleic Acid(DNA) and Ribonucleic Acid(RNA) next-generation sequencing (NGS), the investigators aim to detect driver genetic alterations to investigate the real-world frequency of driver gene positivity in postoperative samples from patients with lung adenocarcinoma-whose EGFR and ALK status had been previously excluded via pathological complete response(pCR) or DNA-based next-generation sequencing-yet still did not attain pathological complete response(pCR) after neoadjuvant immunotherapy. Additionally, the study will characterize the driver-positive patient subgroup and compare the efficacy of postoperative adjuvant immunotherapy between driver-positive and driver-negative populations.
Study Type
OBSERVATIONAL
Enrollment
300
Not applicable- observational study
Tianjin Medical University Cancer Institute and Hospital(Lead Center)
Tianjin, China
Proportion of driver-alteration-positive patients detected by combined DNA+RNA testing
We selected patients with lung adenocarcinoma who had received preoperative neoadjuvant immunotherapy, did not achieve pathological complete response (pCR) after surgery, and had pre-treatment biopsy samples testing negative for EGFR and ALK alterations. Subsequent combined DNA/RNA next-generation sequencing (NGS) was performed using the 3DMed Onco™ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study.
Time frame: through study completion, an average of 1 year
Comparative Analysis of Adjuvant Immunotherapy Efficacy Between Driver-Alteration-Positive and Negative Cohorts
For the comparison between driver gene-positive and negative populations: Disease-Free Survival (DFS) will be compared between patients who received adjuvant immunotherapy and were driver gene-positive versus those who were driver gene-negative. DFS is defined as the time from surgery to the first occurrence of disease recurrence, distant metastasis, or death from any cause.
Time frame: through study completion, an average of 1 year
Stratified Analysis of EGFR/ALK-Positive Versus Other Driver-Alteration-Positive Subgroups
For the stratified analysis among positive populations: Among the driver gene-positive patients who received adjuvant immunotherapy, a stratified analysis will be performed comparing patients with EGFR or ALK mutations versus those with mutations in other driver genes (e.g., ROS1, BRAF V600E, MET, RET, etc.).
Time frame: through study completion, an average of 1 year
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