Study of N-803, tislelizumab and docetaxel combination versus docetaxel alone for patients with advanced or metastatic non-small cell lung cancer resistant to immune checkpoint inhibitors
This study focuses on patients with Advanced or Metastatic Non-Small Cell Lung Cancer who have previously received immunotherapy but their disease has continued to progress. The research evaluates a combination treatment approach using three medications: N-803, tislelizumab, and docetaxel, comparing it to treatment with docetaxel alone. Tislelizumab and N-803 are experimental drugs designed to help the immune system fight cancer cells, while docetaxel is a commonly used chemotherapy medication.
The main purpose of this research is to determine if the combination of these three medications can help patients live longer compared to using docetaxel by itself. The study involves two groups of patients – one receiving all three medications, while the other group receives only docetaxel. The medications are given through different methods: tislelizumab and docetaxel are given through an intravenous infusion (into a vein), while N-803 is given as a subcutaneous injection (under the skin).
During the study, patients will receive treatment and have regular check-ups to monitor their health and how well the treatment is working. The treatment will continue as long as it appears to be helping and the side effects are manageable. Doctors will use special scanning techniques to measure if the tumors are shrinking and will track how long patients live after starting the treatment.
1Initial treatment phase
You will be randomly assigned to one of two treatment groups:
Group 1: You will receive a combination of three medications: tislelizumab (given through an intravenous infusion), nogapendekin alfa inbakicept (given as a subcutaneous injection), and docetaxel (given through an intravenous infusion)
Group 2: You will receive only docetaxel through an intravenous infusion
2Regular monitoring
Your doctor will regularly check your health status using imaging scans to measure tumor response
Blood tests will be performed to monitor your overall health
Your side effects will be tracked and documented
3Treatment continuation
Treatment will continue as long as your disease does not worsen
Your doctor will assess if the benefits of continuing treatment outweigh any side effects you may experience
4Follow-up period
After completing treatment, you will need to use effective birth control for 7 months if you are of childbearing age
Regular check-ups will continue to monitor your health status
The study is expected to continue until December 31, 2029
Who Can Join the Study?
Must be at least 18 years old
Must be able to understand and sign an informed consent form
Must have confirmed stage IV non-small cell lung cancer
Must have developed resistance to previous immunotherapy treatment after initially responding to it for at least 6 months
Must have at least one specific genetic change (EGFR, ROS1, NTRK, BRAF, MET, RET, or KRAS) in their tumor
Must have received 1-2 previous targeted treatments that were approved for their specific genetic change
For patients with specific EGFR mutations, must have previously received osimertinib treatment
Must be able to perform daily activities with some limitations (ECOG status 0-2)
Must have tumors that can be measured using standard imaging techniques
Must be able to attend all required study visits and follow-up appointments
Must agree to use effective birth control methods during the study and for 7 months after completing treatment
For patients with HIV, must be on anti-HIV medication with undetectable virus levels in the last 6 months
Who Cannot Join the Study?
History of other types of cancer in the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer)
Active brain metastases (cancer that has spread to the brain) that are not treated and stable
Previous treatment with immunotherapy for lung cancer
Presence of an autoimmune disease (where the body’s immune system attacks healthy cells)
Use of systemic corticosteroids (medications like prednisone) or other medications that suppress the immune system
Active or untreated hepatitis B or C infection
Known HIV infection
Serious heart conditions in the past 6 months
Uncontrolled high blood pressure
History of organ transplant
Any other serious medical condition that could interfere with study participation
Pregnancy or breastfeeding
Inability to swallow oral medications
Known allergic reactions to study medications
Participation in another clinical trial within the past 30 days
N-803 is a biological therapy designed to boost the immune system’s ability to fight cancer cells. It works by stimulating certain immune cells to become more active against tumors.
Tislelizumab is an immunotherapy medication that helps the body’s immune system attack cancer cells. It belongs to a group of drugs called checkpoint inhibitors, which work by blocking certain proteins that prevent immune cells from recognizing and destroying cancer cells.
Docetaxel is a chemotherapy medication used to treat various types of cancer, including non-small cell lung cancer. It works by interfering with the ability of cancer cells to divide and grow, ultimately causing them to die.
Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the large cells of the lung, including both squamous and non-squamous cells. The disease typically develops slowly and may spread from the lungs to nearby tissues and other parts of the body. In advanced stages, the cancer cells spread (metastasize) to other organs, commonly affecting the bones, liver, or brain. NSCLC accounts for the majority of all lung cancer cases and can cause symptoms such as persistent cough, chest pain, and breathing difficulties. The condition usually progresses through distinct stages, from localized tumors to more extensive spread throughout the body.
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