Could a cholesterol drug boost chemo in resistant lung cancer?
NCT ID NCT07351565
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is for people with non-small cell lung cancer that has stopped responding to second-line treatment. Researchers will use a lab test on a patient's own tumor cells to pick the best chemotherapy drugs, then add the statin pitavastatin. The goal is to see if this personalized combo can shrink tumors. About 22 adults aged 18-75 will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age: 18 to 75 years old. * Non-small cell lung cancer diagnosed through pathological methods (including histology or cytology). * Resistance to second-line drug therapy, with imaging (based on RECIST 1.1 criteria) confirming tumor response as either progressive disease (PD) or stable disease (SD). * Presence of measurable lesions according to RECIST 1.1 criteria: tumor lesions must have a CT scan length of ≥ 10 mm; lymph node lesions must have a CT scan short diameter of ≥ 15 mm; scan slice thickness should not exceed 5 mm; and measurable lesions must not have undergone local treatments such as radiotherapy or cryotherapy. * ECOG Performance Status: 0-2 points. * Expected survival period of at least 6 months. * Hematological function is considered sufficient, defined as: absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 80 × 10\^9/L; hemoglobin ≥ 90 g/L (no history of blood transfusion within the past 7 days, and not corrected with G-CSF or other hematopoietic stimulating factors). * Adequate liver function defined as having total bilirubin levels ≤ 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the ULN. * Adequate renal function, defined as a creatinine clearance rate of ≥ 50 mL/min (calculated using the Cockcroft-Gault formula). * Adequate coagulation function defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times the upper limit of normal (ULN). If the subject is receiving anticoagulant therapy, coagulation function is considered adequate as long as the INR/PT values fall within the therapeutic range specified for the anticoagulant medication. * For female subjects of childbearing age, a negative urine or serum pregnancy test must be conducted within three days prior to the first administration of the study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. * If there is a risk of conception, male and female patients should use highly effective contraception (i.e., methods with an annual failure rate of less than 1%) and continue for at least 180 days after stopping the trial treatment. Note: If abstinence is the subject's usual lifestyle and preferred contraceptive method, then abstinence is acceptable. * The subjects voluntarily joined this study, signed a written informed consent form before any trial-related procedures were implemented, demonstrated good compliance, and cooperated with follow-up. Exclusion Criteria: * Individuals known to be allergic to the active or inactive ingredients of pitavastatin, or to drugs with chemical structures similar to pitavastatin. * Individuals with known allergies to pemetrexed, paclitaxel, gemcitabine, or platinum. * Active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction requiring clinical intervention. * Symptomatic, uncontrolled brain metastases or leptomeningeal metastases, or controlled brain metastases with symptoms lasting less than 2 months. * Diagnosed with malignant tumors other than small cell lung cancer within two years prior to enrollment, excluding completely treated basal or squamous cell skin cancer and/or radically resected in situ cancer. * Has undergone major surgery within the 4 weeks prior to the start of the study or has experienced complications or sequelae that have not yet resolved. * Suffering from serious or uncontrolled illnesses, including but not limited to: uncontrollable nausea and vomiting; inability to alleviate symptoms of intestinal obstruction; inability to swallow study medications; gastrointestinal diseases that may interfere with drug absorption and metabolism; respiratory syndrome caused by pleural effusion or ascites (≥ CTCAE grade 2 dyspnea); active viral infections (HIV, HBV, HCV); or uncontrolled epileptic seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders hindering informed consent. * Having a tendency to bleed and a history of thrombosis, specifically: * Any bleeding events of CTCAE grade 2 occurring within the first 3 months of screening, or grade 3 or higher within the first 6 months. * Active bleeding, coagulation dysfunction, bleeding tendency, or current treatment with thrombolytic or anticoagulant therapy. * Requirement for anticoagulant therapy with medications such as warfarin or heparin. * Requirement for long-term antiplatelet therapy, such as aspirin or clopidogrel. * Thrombotic or embolic events within the past six months (including CVA/TIA and pulmonary embolism). * Significant cardiovascular history, specifically: * NYHA Class III and IV congestive heart failure. * Unstable angina, newly diagnosed angina, or myocardial infarction within the previous 12 months. * Arrhythmia requiring therapeutic intervention (patients taking beta blockers or digoxin may be enrolled). * CTCAE Grade ≥ 2 valvular heart disease. * Poor control of hypertension (systolic BP \> 150 mmHg or diastolic BP \> 100 mmHg). * History of non-infectious pneumonia requiring corticosteroid treatment within one year prior to enrollment, or a current diagnosis of non-infectious pneumonia. * Any past or current diseases, treatments, or laboratory abnormalities that may interfere with the research results, affect the patient's full participation, or lead the researcher to believe that the patient is unsuitable to participate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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