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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not applicable- observational study | Other | Not applicable- observational study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Oncoâ„¢ Core Tissue Detection Kit. The proportion of patients with identified driver genomic alterations served as the primary endpoint of the study. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This multicenter, retrospective cohort study plans to enroll patients with non-small cell lung cancer (NSCLC). Cases meeting the eligibility criteria between January 2022 and December 2024 will first be identified through the hospital pathology information management system. The screening process consists of two stages:
Initial Screening: Extraction of data from electronic medical records for patients aged ≥18 years, with pathologically confirmed NSCLC, and who underwent genetic testing prior to surgery.
Collection of Neoadjuvant Immunotherapy Information:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongsheng Yue Chief Physician of Surgery | Contact | +8602223109106 | yuedongsheng_cg@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital(Lead Center) | Tianjin | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2025 | Sep 14, 2025 |
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| 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.). | through study completion, an average of 1 year |
| Prot_000.pdf |