Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In
This study is for people with advanced non-small cell lung cancer that has gotten worse even after receiving earlier treatments, including immunotherapy. Researchers want to compare a new combination of medicines with a standard chemotherapy drug called docetaxel. The new combinations either involve a drug called N-803 plus tislelizumab and docetaxel, or a previous failed immunotherapy combined with docetaxel. The main aim is to see if these new combinations work better at treating the cancer and are safe for patients. Participants will be put into different groups by chance to receive either the new combination or docetaxel alone, and doctors will carefully monitor their progress.
At a glance
What is this study about?
This study is for individuals diagnosed with advanced non-small cell lung cancer (NSCLC) that is at Stage IV. This means the cancer has spread to other parts of the body. Unfortunately, for these patients, their previous treatments, which included a type of immunotherapy and chemotherapy, have stopped working effectively.
The main goal of this research is to test if new combinations of medicines can be more effective than standard chemotherapy alone for these patients. One new combination involves two drugs, N-803 and tislelizumab, given alongside chemotherapy called docetaxel. Another approach looks at combining a past immunotherapy (that didn't work well enough) with docetaxel. By comparing these combinations against docetaxel alone, doctors hope to find better ways to treat this type of lung cancer, aiming to improve patients' health and quality of life.
Participants in the study will be split into different treatment groups by chance, like flipping a coin, to ensure a fair comparison. This helps researchers understand whether the new treatments are truly responsible for any improvements. The study is "open-label," which means both the patients and their doctors will know which treatment they are receiving. This type of study is an important step in developing new treatments and understanding how they work.
Key takeaways
- This study is for advanced non-small cell lung cancer that has progressed after previous treatments.
- It compares new drug combinations against standard chemotherapy (docetaxel).
- Participation involves being assigned to a treatment group by chance.
- Both you and your doctor will know which treatment you receive.
- Specific prior treatments are required for eligibility, including immunotherapy and chemotherapy.
- If your cancer has specific gene changes, you must have tried certain targeted therapies first.
Who may be eligible?
To join this study, you must be at least 18 years old. You need to have been diagnosed with advanced (Stage IV) non-small cell lung cancer, and your cancer must have stopped responding to previous treatments. These past treatments should have included an immunotherapy drug and a type of chemotherapy that contains platinum.
If your cancer has specific genetic changes (like EGFR, ROS1, or others), you might also be eligible. If you have these changes, you must have already tried specific targeted treatments for them. For example, if you have EGFR mutations, you should have received a drug called osimertinib previously. The study team will check your medical history to make sure you meet all these requirements.
It's important that you are able to understand what taking part in a study means and are willing to sign a form agreeing to participate. This is called informed consent. People of all genders and ethnic backgrounds are welcome to apply.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you at least 18 years old?
- Do you have advanced (Stage IV) non-small cell lung cancer?
- Has your cancer worsened after receiving immunotherapy AND platinum-based chemotherapy?
- If your cancer has specific genetic changes (like EGFR), have you already tried the recommended targeted treatments for them?
- Are you able to provide informed consent (agree to participate after understanding the study)?
What does participation involve?
The detailed plan for what taking part involves is not fully described in the brief summary. However, typically in clinical trials like this, you would have regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor your health, perform physical exams, and likely take blood samples and scans (like X-rays or CT scans) to see how you're responding to the treatment. You would receive the study medication as prescribed by the research team. The study involves comparing different treatments, so you would be assigned to one of the treatment groups by chance. This study will be ongoing until the researchers have enough information to compare the treatments effectively. You will be monitored closely throughout the study and for a period afterwards.
Potential risks and benefits
Locations (36)
- Highlands Oncology GroupVerified postcodeSpringdale, United States· Recruiting
- Chan Soon-Shiong Institute for MedicineVerified postcodeEl Segundo, United States· Recruiting
- MemorialCare - Orange Coast Medical CenterVerified postcodeFountain Valley, United States· Recruiting
- OPN Healthcare INCVerified postcodeGlendale, United States· Completed
- OPN Healthcare INC/ Cancer and Blood Specialty ClinicVerified postcodeLos Alamitos, United States· Completed
- Holy Cross HospitalVerified postcodeFort Lauderdale, United States· Recruiting
- The Oncology Institute of Hope and InnovationVerified postcodeFort Lauderdale, United States· Recruiting
- Moffit Cancer CenterVerified postcodeTampa, United States· Recruiting
- Emory University - Winship Cancer InstituteVerified postcodeAtlanta, United States· Recruiting
- Barnes-Jewish Hospital - Siteman Cancer Center (Washington University - St. Louis)Verified postcodeSt Louis, United States· Recruiting
- Carolina Oncology SpecialistsVerified postcodeHickory, United States· Recruiting
- University of Cincinnati Medical CenterVerified postcodeCincinnati, United States· Recruiting
Common questions
What kind of cancer is this study for?
It's for advanced non-small cell lung cancer that has spread and worsened despite previous treatments.
What kind of treatments will be given in this study?
You might receive a new drug combination (N-803 plus tislelizumab plus docetaxel) or a previous failed immunotherapy combined with docetaxel, or just docetaxel alone.
How will I know which treatment I'm getting?
This is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.
What if my previous treatments didn't work?
This study is specifically for people whose non-small cell lung cancer has progressed after standard treatments, including an immunotherapy and platinum-based chemotherapy.
What if I have certain gene changes in my cancer?
If your cancer has specific genetic alterations, you might need to have tried targeted treatments for those changes already to be eligible.
How to find out more
Phillip Trieu
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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