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Study of Sitravatinib and Nivolumab vs. Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Chemotherapy and Checkpoint Inhibitor Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Advanced Non-Squamous Non-Small Cell Lung Cancer. The study is comparing the effectiveness of a new treatment combination against an existing treatment. The new treatment involves two medications: Sitravatinib, which is taken as a capsule, and Nivolumab, which is given through an infusion into a vein. The existing treatment being compared is Docetaxel, also administered as an infusion.

The purpose of the study is to see if the combination of Sitravatinib and Nivolumab can help patients live longer compared to those receiving Docetaxel. Participants in the study will be randomly assigned to receive either the new combination treatment or Docetaxel. The study will monitor the participants over time to assess their overall survival and any side effects they may experience. The study will also look at other factors such as how well the cancer responds to the treatment and the quality of life of the participants.

This trial is specifically for patients whose lung cancer has progressed after receiving previous treatments, including platinum-based chemotherapy and a type of therapy known as a checkpoint inhibitor. The study aims to provide more information on the potential benefits and safety of the new treatment combination for patients with this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is randomly assigned to one of two treatment groups. The first group receives a combination of sitravatinib and nivolumab, while the second group receives docetaxel.
Step 2
Treatment with sitravatinib and nivolumab
Patients in the first group take sitravatinib orally in the form of hard capsules. The specific dosage and frequency are determined by the study protocol.
In addition to sitravatinib, these patients receive nivolumab through an intravenous infusion. The dosage and frequency are also specified by the study protocol.
Step 3
Treatment with docetaxel
Patients in the second group receive docetaxel through an intravenous infusion. The dosage and frequency are determined by the study protocol.
Step 4
Monitoring and assessments
Throughout the study, patients undergo regular monitoring to assess their overall health and response to treatment. This includes evaluating the overall survival and monitoring for any side effects or adverse events.
Secondary assessments include measuring the objective response rate, duration of response, clinical benefit rate, progression-free survival, and the 1-year survival rate.
Patients also complete questionnaires to report on their symptoms and quality of life, using tools like the Lung Cancer Symptom Scale and the European Quality of Life Five Dimensions Questionnaire.
Step 5
Completion of the study
The study is estimated to conclude by December 31, 2024. At the end of the study, final assessments are conducted to evaluate the outcomes and gather data on the effectiveness and safety of the treatments.

Who can join the trial?

8 criteria

Have a diagnosis of Non-Squamous Non-Small Cell Lung Cancer, which is a type of lung cancer.
Have received at least one, but not more than two, previous treatments for advanced cancer.
Have been treated with a PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based chemotherapy, either together or one after the other. These are specific types of cancer treatments.
The most recent treatment must have included a checkpoint inhibitor therapy, and the cancer must have shown signs of getting worse on or after this treatment.
Be a candidate to receive docetaxel as a second or third line of therapy. Docetaxel is a type of chemotherapy drug.
Be within the age range that is eligible for the study.
Both male and female participants are eligible.
Individuals from vulnerable populations may be included.

Who cannot join the trial?

4 criteria

Patients who have not experienced disease progression after receiving platinum-based chemotherapy and CIT (a type of cancer treatment).
Patients with a type of lung cancer other than non-squamous non-small cell lung cancer.
Patients who are not within the specified age range for the study.
Patients who are not able to provide informed consent or are part of a vulnerable population that cannot participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Sitravatinib
is a medication being studied for its potential to help treat advanced non-squamous non-small cell lung cancer. It is used in combination with another medication to see if it can improve survival in patients whose cancer has progressed after previous treatments.
Nivolumab
is an immunotherapy drug that helps the body's immune system fight cancer cells. In this trial, it is combined with sitravatinib to evaluate if the combination can provide better outcomes for patients with advanced lung cancer.
Docetaxel
is a chemotherapy drug that is used to treat various types of cancer, including lung cancer. In this study, it is used as a comparison to see if the combination of sitravatinib and nivolumab is more effective in improving patient survival.

What is already known about the treatment

Sitravatinib
Sitravatinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced non-squamous non-small cell lung cancer. It is not yet widely used in standard medical practice but shows promise in ongoing research. The medication works by inhibiting multiple receptor tyrosine kinases, which are involved in tumor growth and immune evasion. Sitravatinib is classified as a tyrosine kinase inhibitor.
Nivolumab
Nivolumab is given through intravenous infusion and is an established medication in the treatment of various cancers, including non-small cell lung cancer. It is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, thereby enhancing the body's immune response against cancer cells. Nivolumab is classified as a monoclonal antibody.
Docetaxel
Docetaxel is administered via intravenous infusion and is a well-known chemotherapy drug used in the treatment of various cancers, including non-small cell lung cancer. It functions by disrupting the microtubule network in cells, which is essential for cell division, thus inhibiting cancer cell growth. Docetaxel is classified as a taxane-based chemotherapy agent.

Investigated diseases

Advanced Non-Squamous Non-Small Cell Lung Cancer – This is a type of lung cancer that originates in the epithelial cells of the lung but does not have the squamous cell characteristics. It is classified as "non-small cell" due to the size and appearance of the cancer cells under a microscope. The disease typically progresses by spreading to nearby tissues and potentially to other parts of the body. Patients often experience symptoms such as persistent cough, chest pain, and difficulty breathing as the cancer advances. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.