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Study on Atorvastatin’s Role in Enhancing Immunotherapy for Patients with Triple Negative Breast Cancer and Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial, known as the STARK trial, is investigating the use of Atorvastatin (a type of statin medication commonly used to lower cholesterol) in combination with immunotherapy (treatments that help the immune system fight cancer) for patients with Triple Negative Breast Cancer (TNBC) and Non-Small Cell Lung Cancer (NSCLC). The purpose of the study is to determine if adding Atorvastatin can improve the effectiveness of immunotherapy treatments like pembrolizumab in these cancer types.

For breast cancer patients, the study involves receiving Atorvastatin alongside standard immunotherapy and chemotherapy before surgery. For lung cancer patients, Atorvastatin will be given with first-line immunotherapy. The researchers will collect tumor samples and blood samples at different timepoints to analyze how the combination treatment affects the immune response in the tumor and the presence of cancer DNA in the blood.

The trial will monitor both how well the treatment works against the cancer and any side effects that may occur. Various advanced laboratory techniques will be used to understand how Atorvastatin affects the immune system’s response to cancer and to identify markers that might predict which patients will benefit most from this combination approach.

1 Study Enrollment and Initial Assessment

After signing the informed consent form, you will undergo baseline assessments to confirm eligibility for the STARK trial, which studies if atorvastatin (a cholesterol-lowering medication) can improve the effects of immunotherapy.

Your medical history will be reviewed and you will have tests to check your organ function, including blood tests to ensure adequate bone marrow, liver, and kidney function.

Depending on your cancer type (either Triple Negative Breast Cancer or Non-Small Cell Lung Cancer), different baseline requirements will apply.

2 Tumor Sample Collection

A tumor sample will be collected before starting treatment.

For breast cancer patients (Cohort 1), this involves obtaining tissue from your tumor.

For lung cancer patients (Cohort 2), either a fresh tumor sample will be collected or an existing sample may be used if it was obtained within 12 months prior to enrollment and you received no cancer treatment after the sample was taken.

3 Treatment Assignment

You will be randomly assigned to receive either standard immunotherapy treatment alone or standard immunotherapy plus atorvastatin (TORVAST 40 mg film-coated tablets).

The immunotherapy you receive will depend on your cancer type:

4 Treatment Phase – Breast Cancer Patients (Cohort 1)

If you have Triple Negative Breast Cancer, you will receive neoadjuvant therapy (treatment before surgery) consisting of pembrolizumab (an immunotherapy drug) plus chemotherapy.

If assigned to the atorvastatin group, you will take a daily 40 mg tablet of atorvastatin in addition to your standard treatment.

This treatment will continue until you undergo definitive breast surgery.

5 Treatment Phase – Lung Cancer Patients (Cohort 2)

If you have Non-Small Cell Lung Cancer, you will receive first-line immunotherapy according to standard clinical practice.

If assigned to the atorvastatin group, you will take a daily 40 mg tablet of atorvastatin in addition to your standard immunotherapy.

Treatment will continue according to standard guidelines for immunotherapy in lung cancer.

6 Follow-up Assessments and Sample Collection

Throughout treatment, you will have regular follow-up visits to monitor your response to treatment and any side effects.

For breast cancer patients, a second tumor sample will be collected at time point T1 (likely during surgery) to compare with your baseline sample.

For lung cancer patients, blood samples will be collected to analyze circulating tumor DNA (ctDNA) at baseline and after 6 weeks of treatment.

Additional blood samples may be collected to study immune cells and metabolic markers.

7 Side Effect Monitoring

Throughout the study, you will be monitored for side effects from both the immunotherapy and atorvastatin.

Any side effects will be graded according to standardized criteria (NCI CTCAE v5.0).

Your doctor will manage any side effects that occur during treatment.

8 Treatment Completion and Follow-up

For breast cancer patients, the treatment will end when you undergo surgery.

For lung cancer patients, immunotherapy (with or without atorvastatin) will continue according to standard guidelines until disease progression or unacceptable toxicity.

After completing treatment, you will continue to be followed to assess long-term outcomes including survival and cancer recurrence or progression.

Who Can Join the Study?

  • You must be able to understand and be willing to sign an informed consent document.
  • You must be willing and able to follow the scheduled visits, treatment plan, lab tests, and other study procedures.
  • You must be willing to provide biological samples (like blood or tissue) as required by the study.
  • You must be at least 18 years old when signing the consent form.
  • You must have an ECOG Performance Status of 0-1 (this measures your ability to perform daily activities and self-care).
  • You must have adequate organ and bone marrow function as shown by specific blood tests that measure:
    • White blood cell counts (Absolute Neutrophil Count)
    • Platelets (cells that help blood clot)
    • Hemoglobin (protein in red blood cells that carries oxygen)
    • Bilirubin (substance in bile that can indicate liver function)
    • Transaminases (liver enzymes)
    • Creatinine (substance that can indicate kidney function)
  • For Triple Negative Breast Cancer patients (Cohort 1):
    • You must have confirmed breast cancer that is HER2-negative, estrogen receptor negative, and progesterone receptor negative
    • You must have untreated stage II-III cancer
    • You must be planning to have breast surgery after initial treatment
    • You must be a candidate for treatment with pembrolizumab (an immunotherapy) plus chemotherapy
    • You must have an available tumor sample collected before starting treatment
  • For Non-Small Cell Lung Cancer patients (Cohort 2):
    • You must have confirmed lung cancer at Stage IIIB (not treatable with radical therapy) or Stage IV
    • Your cancer must not have certain genetic mutations (EGFR, ALK, ROS1, BRAF, MET, RET, KRAS)
    • You must not have had prior treatment for advanced lung cancer
    • You must have high levels of PD-L1 (≥50%, a protein that helps determine if immunotherapy might work)
    • You must be a candidate for first-line immunotherapy treatment
    • You must have an available tumor sample
  • If you are able to have children, you must agree to use highly effective birth control methods throughout the study or practice sexual abstinence.

Who Cannot Join the Study?

  • Having a prior allergic reaction to atorvastatin (a cholesterol-lowering medication) or similar drugs
  • Having active autoimmune disease that requires treatment with systemic medications that suppress the immune system
  • Having received treatment with immunotherapy (treatments that help your immune system fight cancer) within the last 6 months
  • Having received treatment with statins (cholesterol-lowering medications) within the last 3 months
  • Being pregnant or breastfeeding
  • Having severe liver disease (liver not functioning properly)
  • Having uncontrolled diabetes (high blood sugar levels that are not managed)
  • Having active infections requiring treatment
  • Having other serious medical conditions that would make participation unsafe
  • Being unable to swallow oral medications
  • Having had major surgery within the past 4 weeks

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Aharwsk Odupjstppcm Pfhj Genkkqum Xwhfp Bergamo Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
15.07.2025

Trial locations

Investigated drugs:

Atorvastatin is a medication that belongs to a group of drugs called statins. It is commonly used to lower cholesterol levels in the blood. In this study, researchers are investigating if atorvastatin can enhance the effects of immunotherapy (a type of cancer treatment that helps the immune system fight cancer) in patients with Triple Negative Breast Cancer and Non Small Cell Lung Cancer.

Immune checkpoint inhibitors are a type of immunotherapy that work by blocking certain proteins that prevent the immune system from attacking cancer cells. By blocking these “checkpoints,” these medications allow the immune system to recognize and destroy cancer cells more effectively.

Investigated diseases:

Non Small Cell Lung Cancer (NSCLC) – A type of lung cancer that accounts for about 85% of all lung cancer cases. It develops when cells in the lungs grow uncontrollably, forming tumors. NSCLC typically grows and spreads more slowly than small cell lung cancer. There are several subtypes of NSCLC, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease often progresses without symptoms in early stages, with later symptoms including persistent cough, chest pain, shortness of breath, and unexplained weight loss.

Triple Negative Breast Cancer (TNBC) – An aggressive type of breast cancer characterized by the absence of three receptors: estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). TNBC accounts for about 10-15% of all breast cancers and tends to grow and spread faster than other types. It most commonly affects younger women and those with a BRCA1 gene mutation. TNBC typically presents as a lump in the breast and may cause changes in breast appearance, nipple discharge, or skin changes.

Trial ID:
2024-518500-47-00
Protocol code:
2024-518500-47-00
Trial Phase:
Therapeutic exploratory (Phase II)

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