Non-Small Cell Lung CancerPhase 1CPPGPTCLCNCT07351565
Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer
A Phase 1 study testing Pitavastatin 1 mg daily or 4 mg daily in people with Non-Small Cell Lung Cancer, run by Chang Chen.
Trial summary
The primary objective of this study is to evaluate the objective response rate (ORR = CR + PR) of pitavastatin combined with chemotherapy, guided by PTC (patient-derived tumor-like cell cluster) drug sensitivity, in patients resistant to second-line treatment (PD/SD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Pitavastatin 1 mg daily or 4 mg daily
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 31 Dec 2026
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer: An Exploratory Phase I Trial
The primary objective of this study is to evaluate the objective response rate (ORR = CR + PR) of pitavastatin combined with chemotherapy, guided by PTC (patient-derived tumor-like cell cluster) drug sensitivity, in patients resistant to second-line treatment (PD/SD). The ORR is defined as the proportion of patients achieving a response after four cycles of combination therapy. The main questions it aims to answer are:
- Does PTC-guided medication is feasible
- Does the administration of Pitavastatin combined with chemotherapy can improve the objective response rate (ORR) in second-line drug-resistant patients
Read more
The medication to participants will be strictly guided by PTC drug testing. The drugs examined in this study included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first.
Pirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. Participants must demonstrate good compliance throughout the entire study, especially when the dosage is reduced, to ensure they receive the correct prescribed dose.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Pitavastatin 1 mg daily or 4 mg daily
- 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.
Pitavastatin 1 mg daily or 4 mg dailyDrug
The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first.
Pirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin plus chemotherapy | Experimental | The drugs used in this arm included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. Treatment plan: The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first. Pitavastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. Receives: Drug: Pitavastatin 1 mg daily or 4 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1.
Measured: From the date of first dose until disease progression or death from any cause, assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351565
- Sponsor's protocol ID
- L25-751-1
- Acronym
- CPPGPTCLC
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer: An Exploratory Phase I Trial
- ClinicalTrials.gov ID
- NCT07351565
- Acronym / sponsor ID
- CPPGPTCLC / L25-751-1
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Chang ChenUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 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 primary objective of this study is to evaluate the objective response rate (ORR = CR + PR) of pitavastatin combined with chemotherapy, guided by PTC (patient-derived tumor-like cell cluster) drug sensitivity, in patients resistant to second-line treatment (PD/SD). The ORR is defined as the proportion of patients achieving a response after four cycles of combination therapy. The main questions it aims to answer are:
- Does PTC-guided medication is feasible
- Does the administration of Pitavastatin combined with chemotherapy can improve the objective response rate (ORR) in second-line drug-resistant patients
The medication to participants will be strictly guided by PTC drug testing. The drugs examined in this study included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first.
Pirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. Participants must demonstrate good compliance throughout the entire study, especially when the dosage is reduced, to ensure they receive the correct prescribed dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin plus chemotherapy | Experimental | Drug: Pitavastatin 1 mg daily or 4 mg dailyThe drugs used in this arm included chemotherapy agents such as cisplatin for injection, carboplatin for injection, pemetrexed disodium for injection, paclitaxel injection, gemcitabine hydrochloride for injection, and docetaxel injection, as well as pitavastatin. Treatment plan: The selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first. Pitavastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitavastatin 1 mg daily or 4 mg dailyThe selection of chemotherapy drugs was based on the results of PTC drug sensitivity testing, with combination therapy showing the highest sensitivity. Drug dosages were administered according to the recommended standards outlined in the guidelines (every three weeks, intravenous). Treatment continued until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol, whichever occurred first. Pirvastatin is administered orally by the subjects themselves at a fixed time each morning (4 mg, once daily), with or without food, until disease progression or intolerance occurs. | Drug | Pitavastatin plus chemotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: From the date of first dose until disease progression or death from any cause, assessed up to 6 months.
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1.
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitavastatin 1 mg daily or 4 mg daily in people with Non-Small Cell Lung Cancer, run by Chang Chen.
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 13 inclusion and 21 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Hang Su, Doctor (86+13917810850, dreamsuhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: From the date of first dose until disease progression or death from any cause, assessed up to 6 months.). 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 20 Jan 2026.