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N-803 + Standard Care for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new cancer drug, N-803, to see if it is safe and effective when used with the current standard of care for advanced or metastatic non-small cell lung cancer (NSCLC). Patients will be randomly assigned to receive either N-803 + standard of care or standard of care alone. The trial will last up to 2 years, and patients will be monitored for disease progression, post-therapies, and survival.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My tumor does not have specific genetic changes in EGFR, ALK, BRAF, ROS1, or NTRK.The tumor can be measured and evaluated using a specific method called RECIST 1.1.I have a history of HIV or active hepatitis B or C.I am 18 years old or older.I am willing to give blood samples for cancer analysis before starting treatment.I haven't had chemotherapy for advanced lung cancer but may have had it for stage 3.I agree to use effective birth control during and after the treatment.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.I haven't been in a drug study or taken experimental treatments in the last 30 days, except for testosterone-lowering therapy.I have a systemic autoimmune disease like lupus or rheumatoid arthritis.I have had an organ transplant, lung issues needing steroids, or took immunosuppressants recently.I had cancer before, but it was either treated successfully over 3 years ago, is a non-aggressive type under control, or was completely removed.My lab results show my organs are not functioning well.I do not have serious heart problems or uncontrolled high blood pressure.I need oxygen all the time due to my advanced cancer.My lung cancer is at stage 3 or 4 and cannot be treated with surgery or chemoradiation.I haven't had chemotherapy, major surgery, or chest radiation in the last 3 weeks.I need other cancer treatments while on this trial, but palliative radiation is okay.I am currently pregnant or nursing.I do not have any serious illnesses that would make the study drug unsafe for me.I have not received a live vaccine in the last 30 days.My NSCLC tumor shows some PD-L1 activity.I am willing to provide my tumor biopsy for research if it's available.I agree to provide a tumor biopsy 9 weeks after treatment starts if it's safe.I have brain metastases but they've been stable for at least 4 weeks.I can attend all required study visits and follow-ups.I am fully active or can carry out light work.I am currently on IV antibiotics for an infection.I am not taking any medications that react badly with the study drugs.
Frequently Asked Questions
Has the FDA given nod to N-803 + Pembrolizumab?
"N-803 + Pembrolizumab is considered safe due to its Phase 3 status and available data that support efficacy and safety."
How many people are subjected to this experiment?
"Unfortunately, this trial is not recruiting patients right now. However, if you're still interested in participating in clinical trials, there are 2440 studies for N-803 + Pembrolizumab and 1559 trials actively admitting participants with non-small cell lung carcinoma (nsclc) that are currently seeking candidates."
What are N-803 + Pembrolizumab indicated for?
"N-803 + Pembrolizumab is a treatment for malignant neoplasms that has also shown to be effective against unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."
Are people still being asked to participate in this clinical trial?
"No, this particular study is not recruiting patients at the moment. This is according to the latest update on clinicaltrials.gov, which also reports that the trial was first posted on May 18th, 2018. Although there are other medical trials searching for participants, this one isn't 3999 of them."
How many study locations are active for this research?
"If you are eligible and interested in enrolling in this trial, it is important to consider the 27 sites that are currently participating. These locations include Miami, Houston, Knoxville and many others. By selecting the site closest to you, you can reduce travel-related stressors."
Are there similar ongoing research projects observing N-803 + Pembrolizumab?
"The first clinical trial for N-803 + Pembrolizumab was conducted in 1997 at City of Hope Comprehensive Cancer Center. In the two decades since, there have been 2611 completed trials. Currently, 2440 trials are still active with a large number taking place in Miami, Florida."
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