Non-small Cell Lung CancerLKB1-NSCLCNCT07710599
LKB1 Expression and Clinical Outcomes in Non-Small Cell Lung Cancer: A Retrospective Cohort Study
An observational study of Non-small Cell Lung Cancer, run by Ling Zhiqiang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 94 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study enrolls 300 patients with pathologically confirmed non-small cell lung cancer with archived frozen tumor samples. All eligible participants received routine clinical pathological examination, targeted gene panel sequencing covering STK11, KRAS, KEAP1, TP53and PD-L1 IHC testing. We collect real-world clinical data, treatment regimens and long-term follow-up data to analyze the predictive value of STK11 mutation combined with co-mutation profiles on chemotherapy, targeted therapy and immune checkpoint inhibitor efficacy.
Who may be able to join
- 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.
Who cannot join
- Pathological diagnosis of small cell lung cancer or mixed small cell/non-small cell lung cancer tumors.
- 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.
- Patients who did not receive first-line systemic therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310022
Hangzhou, Zhejiang, 310022
About this study
Official title: Expression of LKB1 (STK11) and Its Prognostic and Therapeutic Implications in Non-Small Cell Lung Cancer: A Retrospective Cohort Study
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.
Read more
The main questions this study aims to answer are:
- Does LKB1 mutation status independently predict clinical outcomes, including overall survival and progression-free survival, in patients with NSCLC?
- Does LKB1 alteration modify the predictive value of PD-L1 expression and determine differential responses to immunotherapy, chemotherapy, and targeted therapy?
- Do distinct genomic backgrounds defined by LKB1, KRAS, KEAP1, and TP53 co-mutation patterns represent biologically and clinically meaningful subgroups with different therapeutic vulnerabilities?
- 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.
Read the detailed description
The goal of this observational study is to investigate the clinical and biological significance of LKB1 (STK11) alterations in patients with non-small cell lung cancer (NSCLC) and to determine whether LKB1 mutation status, together with co-occurring genomic alterations, can predict therapeutic response and survival outcomes across different treatment strategies.
The main question this study aims to answer is whether LKB1-driven molecular subgroups can define distinct clinical behaviors, immune phenotypes, and treatment vulnerabilities in NSCLC patients.
Participants included in this study are adult patients diagnosed with NSCLC who have available tumor tissue samples, genomic sequencing data, PD-L1 immunohistochemical evaluation, and clinical follow-up information. Approximately 300 patients with NSCLC will be retrospectively enrolled. Clinical characteristics, including age, sex, smoking history, pathological subtype, TNM stage, treatment history, and survival outcomes, will be collected from medical records.
Tumor tissue samples will be analyzed using targeted next-generation sequencing to identify genomic alterations involving LKB1 (STK11), KRAS, KEAP1, TP53, and other cancer-related genes. Immunohistochemistry will be performed to evaluate LKB1 protein expression and PD-L1 expression levels. Genomic profiles will be integrated with clinical characteristics and treatment information, including chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, and combination treatment regimens.
The study will classify patients according to biologically relevant genomic backgrounds, with LKB1 mutation as the primary molecular factor and KRAS, KEAP1, and TP53 alterations considered as important co-molecular modifiers. Different genomic subgroups will be compared to determine their associations with PD-L1 expression patterns, treatment responses, and long-term clinical outcomes.
The study will evaluate whether LKB1 alteration contributes to therapeutic heterogeneity by influencing immune checkpoint inhibitor efficacy and modifying the prognostic impact of PD-L1 expression. In addition, this study will explore whether specific LKB1-associated genomic subtypes represent distinct patient populations with different responses to immunotherapy, chemotherapy, or targeted treatment approaches.
Participants will not receive any experimental intervention as part of this study. All clinical treatments will have been administered according to routine medical practice. The study will analyze previously collected clinical and molecular data, together with long-term follow-up information, to establish an LKB1-centered genomic classification framework for personalized treatment stratification in NSCLC.
The primary outcomes of this study are overall survival (OS) and progression-free survival (PFS). Secondary outcomes include objective response rate (ORR), disease control rate (DCR), treatment-specific clinical benefit, and the relationship between genomic alterations, PD-L1 expression, and therapeutic outcomes.
This study aims to improve the understanding of how LKB1 loss influences tumor immune biology and treatment response in NSCLC and may provide a clinically applicable strategy for identifying patients who are more likely to benefit from specific therapeutic approaches.
- Conditions
- Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Non-Small Cell Lung Cancer Patients | Retrospectively enrolled 300 patients diagnosed with non-small cell lung cancer, archived frozen tumor tissues were collected to detect LKB1 protein expression via immunohistochemistry. Subgroup analysis of LKB1 positive/negative status will be performed statistically after data collection, no prospective intervention or treatment manipulation for subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) of first-line systemic therapy stratified by STK11/LKB1 mutation status
Progression-free survival (PFS), measured in months, is defined as the time from initiation of first-line systemic therapy to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed by retrospective review of radiologic imaging reports and medical records, using RECIST v1.1 criteria when available or treating physician-documented progression in routine clinical practice. LKB1 expression status will be assessed by immunohistochemistry (IHC) using archived tumor tissue and categorized as LKB1-low/loss versus LKB1-preserved/high expression according to the study-defined cutoff. PFS will be summarized according to LKB1 expression status and first-line treatment category.
Measured: 1 year
Secondary outcomes (3)
Overall Survival (OS) stratified by STK11/LKB1 mutation and co-mutation profiles
Overall survival (OS), measured in months, is defined as the time from initiation of first-line systemic therapy to death from any cause. Patients who are alive at the last follow-up will be censored at the date of last known survival status. Survival status and date of death will be collected by retrospective review of medical records, follow-up records, and/or death registry data when available. STK11/LKB1 mutation status and co-mutation profiles, including KRAS, KEAP1, and TP53, will be assessed using next-generation sequencing or other clinically validated molecular testing methods. OS will be summarized according to STK11/LKB1 mutation status and co-mutation profiles.
Measured: 1year
PD-L1 TPS distribution in STK11/LKB1-mutant and wild-type molecular subgroups
PD-L1 tumor proportion score (TPS), measured as the percentage of viable tumor cells showing partial or complete membranous PD-L1 staining, will be assessed by immunohistochemistry (IHC) using available tumor tissue samples. TPS will be recorded as a continuous percentage from 0% to 100% and may also be categorized according to clinically used cutoffs, such as <1%, 1%-49%, and >=50%, when applicable. STK11/LKB1 mutation status and co-mutation profiles, including KRAS, KEAP1, and TP53, will be assessed using targeted next-generation sequencing or other clinically validated molecular testing methods. PD-L1 TPS will be summarized according to STK11/LKB1 mutation status and co-mutation profiles.
Measured: 3months
Correlation between STK11/LKB1 mutation status and clinicopathological features of NSCLC
Collect clinical data including tumor stage, pathological subtype, differentiation, smoking status, age, gender, ECOG status. Analyze the distribution of STK11/LKB1-mutant and wild-type patients in different clinicopathological subgroups.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ling Zhiqiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ling Zhiqiang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710599
- Sponsor's protocol ID
- IRB-2026-735(IIT)
- Other IDs
- IRB-2026-735
- Acronym
- LKB1-NSCLC
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of LKB1 (STK11) and Its Prognostic and Therapeutic Implications in Non-Small Cell Lung Cancer: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07710599
- Acronym / sponsor ID
- LKB1-NSCLC / IRB-2026-735(IIT)
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ling ZhiqiangUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does LKB1 mutation status independently predict clinical outcomes, including overall survival and progression-free survival, in patients with NSCLC?
- Does LKB1 alteration modify the predictive value of PD-L1 expression and determine differential responses to immunotherapy, chemotherapy, and targeted therapy?
- Do distinct genomic backgrounds defined by LKB1, KRAS, KEAP1, and TP53 co-mutation patterns represent biologically and clinically meaningful subgroups with different therapeutic vulnerabilities?
- 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.
Detailed description
The goal of this observational study is to investigate the clinical and biological significance of LKB1 (STK11) alterations in patients with non-small cell lung cancer (NSCLC) and to determine whether LKB1 mutation status, together with co-occurring genomic alterations, can predict therapeutic response and survival outcomes across different treatment strategies.
The main question this study aims to answer is whether LKB1-driven molecular subgroups can define distinct clinical behaviors, immune phenotypes, and treatment vulnerabilities in NSCLC patients.
Participants included in this study are adult patients diagnosed with NSCLC who have available tumor tissue samples, genomic sequencing data, PD-L1 immunohistochemical evaluation, and clinical follow-up information. Approximately 300 patients with NSCLC will be retrospectively enrolled. Clinical characteristics, including age, sex, smoking history, pathological subtype, TNM stage, treatment history, and survival outcomes, will be collected from medical records.
Tumor tissue samples will be analyzed using targeted next-generation sequencing to identify genomic alterations involving LKB1 (STK11), KRAS, KEAP1, TP53, and other cancer-related genes. Immunohistochemistry will be performed to evaluate LKB1 protein expression and PD-L1 expression levels. Genomic profiles will be integrated with clinical characteristics and treatment information, including chemotherapy, targeted therapy, immune checkpoint inhibitor therapy, and combination treatment regimens.
The study will classify patients according to biologically relevant genomic backgrounds, with LKB1 mutation as the primary molecular factor and KRAS, KEAP1, and TP53 alterations considered as important co-molecular modifiers. Different genomic subgroups will be compared to determine their associations with PD-L1 expression patterns, treatment responses, and long-term clinical outcomes.
The study will evaluate whether LKB1 alteration contributes to therapeutic heterogeneity by influencing immune checkpoint inhibitor efficacy and modifying the prognostic impact of PD-L1 expression. In addition, this study will explore whether specific LKB1-associated genomic subtypes represent distinct patient populations with different responses to immunotherapy, chemotherapy, or targeted treatment approaches.
Participants will not receive any experimental intervention as part of this study. All clinical treatments will have been administered according to routine medical practice. The study will analyze previously collected clinical and molecular data, together with long-term follow-up information, to establish an LKB1-centered genomic classification framework for personalized treatment stratification in NSCLC.
The primary outcomes of this study are overall survival (OS) and progression-free survival (PFS). Secondary outcomes include objective response rate (ORR), disease control rate (DCR), treatment-specific clinical benefit, and the relationship between genomic alterations, PD-L1 expression, and therapeutic outcomes.
This study aims to improve the understanding of how LKB1 loss influences tumor immune biology and treatment response in NSCLC and may provide a clinically applicable strategy for identifying patients who are more likely to benefit from specific therapeutic approaches.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Non-Small Cell Lung Cancer Patients | – | –Retrospectively enrolled 300 patients diagnosed with non-small cell lung cancer, archived frozen tumor tissues were collected to detect LKB1 protein expression via immunohistochemistry. Subgroup analysis of LKB1 positive/negative status will be performed statistically after data collection, no prospective intervention or treatment manipulation for subjects. |
Who may qualify
- Ages
- 45 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study enrolls 300 patients with pathologically confirmed non-small cell lung cancer with archived frozen tumor samples. All eligible participants received routine clinical pathological examination, targeted gene panel sequencing covering STK11, KRAS, KEAP1, TP53and PD-L1 IHC testing. We collect real-world clinical data, treatment regimens and long-term follow-up data to analyze the predictive value of STK11 mutation combined with co-mutation profiles on chemotherapy, targeted therapy and immune checkpoint inhibitor efficacy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Pathological diagnosis of small cell lung cancer or mixed small cell/non-small cell lung cancer tumors.
- 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.
- Patients who did not receive first-line systemic therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS) of first-line systemic therapy stratified by STK11/LKB1 mutation status
Time frame: 1 year
Progression-free survival (PFS), measured in months, is defined as the time from initiation of first-line systemic therapy to the first documented disease progression or death from any cause, whichever occurs first. Disease progression will be assessed by retrospective review of radiologic imaging reports and medical records, using RECIST v1.1 criteria when available or treating physician-documented progression in routine clinical practice. LKB1 expression status will be assessed by immunohistochemistry (IHC) using archived tumor tissue and categorized as LKB1-low/loss versus LKB1-preserved/high expression according to the study-defined cutoff. PFS will be summarized according to LKB1 expression status and first-line treatment category.
3 secondary outcomes
Overall Survival (OS) stratified by STK11/LKB1 mutation and co-mutation profiles
Time frame: 1year
PD-L1 TPS distribution in STK11/LKB1-mutant and wild-type molecular subgroups
Time frame: 3months
Correlation between STK11/LKB1 mutation status and clinicopathological features of NSCLC
Time frame: 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Ling Zhiqiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) of first-line systemic therapy stratified by STK11/LKB1 mutation status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.