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LKB1 Expression and Clinical Outcomes in Non-Small Cell Lung Cancer: A Retrospective Cohort Study

NCT07710599 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-07-17

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Ling Zhiqiang

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
94 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-10-01
Completion
2027-10-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710599 on ClinicalTrials.gov