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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Netherlands Cancer Institute	Amsterdam	The Netherlands
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Isuyvekc Cwursm Dvmsapamxlhvuauzx	L'hospitalet De Llobregat	Spain
Fevvqcndu Pmou Ls Igftgeaxbihec Bpxlogrcn Dwg Hnxqyffb Uugkzioulukbg Ly Peh	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	18.12.2020
Spain	Not recruiting	18.12.2020
The Netherlands	Not recruiting	18.12.2020

Trial locations

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.

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.

Trial ID:

2024-516598-60-00

Protocol code:

516-005

NCT ID:

NCT03906071

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?