NCT07710599Active, not recruiting
LKB1 Expression and Clinical Outcomes in Non-Small Cell Lung Cancer: A Retrospective Cohort Study
Expression of LKB1 (STK11) and Its Prognostic and Therapeutic Implications in Non-Small Cell Lung Cancer: A Retrospective Cohort Study
Source: ClinicalTrials.gov · Last updated 17 Jul 2026
Brief summary (registry, in English)
The goal of this observational study is to investigate whether LKB1 alterations can serve as a clinically meaningful biomarker for predicting therapeutic response and survival outcomes in patients with non-small cell lung cancer (NSCLC), and to determine how LKB1 mutation status together with co-occurring genomic alterations influences treatment sensitivity across different therapeutic strategies. This study will include adult patients diagnosed with NSCLC who underwent surgical resection or tumor biopsy, genomic profiling, PD-L1 immunohistochemical evaluation, and clinical follow-up. Tumor samples from approximately 300 patients will be analyzed for genomic alterations involving LKB1 (STK11), KRAS, KEAP1, TP53, and other cancer-related genes. Clinical characteristics, including age, sex, smoking history, TNM stage, treatment modalities (chemotherapy, targeted therapy, immunotherapy), and survival outcomes will be collected and integrated for comprehensive analysis. The main questions this study aims to answer are: 1. Does LKB1 mutation status independently predict clinical outcomes, including overall survival and progression-free survival, in patients with NSCLC? 2. Does LKB1 alteration modify the predictive value of PD-L1 expression and determine differential responses to immunotherapy, chemotherapy, and targeted therapy? 3. Do distinct genomic backgrounds defined by LKB1, KRAS, KEAP1, and TP53 co-mutation patterns represent biologically and clinically meaningful subgroups with different therapeutic vulnerabilities? 4. Can an LKB1-centered genomic classification model improve patient stratification and provide a more accurate framework for personalized treatment selection in NSCLC? The primary outcome measures will include overall survival (OS) and progression-free survival (PFS). Secondary outcome measures will include objective response rate (ORR), disease control rate (DCR), treatment-specific clinical benefit, and the association between genomic alterations, PD-L1 expression, and therapeutic outcomes.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (actual)
- First submitted
- 7 Jul 2026
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- Ling Zhiqiang
- Diseases
- Lung cancer
- NCT number
- NCT07710599
What you commit to
- Study type: Observational
- Participants enrolled: 300
- From 1 Jan 2024 to the primary completion date, 1 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who did not receive first-line systemic therapy.
Other illness
- Pathological diagnosis of small cell lung cancer or mixed small cell/non-small cell lung cancer tumors.
Other
- Insufficient tumor tissue or unavailable testing results that prevent assessment of STK11/LKB1 status, co-mutation profiles, or PD-L1 expression.
- Missing key clinical information, treatment records, or follow-up data required for survival analysis.
Who the study is looking for
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
- Patients who received first-line systemic therapy, including chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, or combined treatment.
- Available clinicopathologic data, including TNM stage, treatment information, and follow-up records.
- Available tumor tissue samples or clinically validated molecular testing results for assessment of STK11/LKB1 status and co-mutation profiles, including KRAS, KEAP1, and TP53.
- Available PD-L1 immunohistochemistry (IHC) results or sufficient tumor tissue for PD-L1 TPS assessment, when applicable.
Age in the registry: 45 years to 94 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.