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Pembrolizumab/Vibostolimab + Docetaxel for Non-Small Cell Lung Cancer
Study Summary
This trial is testing a new cancer treatment involving two drugs, pembrolizumab and vibostolimab, given together or separately. The trial will compare these drugs to a placebo (fake drug) plus a standard cancer drug, docetaxel. The trial is testing whether the new treatment is better than the standard treatment at slowing or stopping cancer growth.
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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Who is running the clinical trial?
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- I am fully active or restricted in physically strenuous activity but can do light work.I had radiotherapy less than 2 weeks ago, except for a short treatment for non-brain issues.I had another cancer but have been free of it for over 3 years after treatment.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have not had a live vaccine in the last 30 days.My cancer progressed after platinum-based chemotherapy for metastatic disease.My lung cancer diagnosis is confirmed and it has spread.I have active or untreated brain metastases or cancer in my spinal fluid.I have been treated with drugs targeting the immune system's T-cells before.I have at least one tumor that can be measured on a CT or MRI scan.I have a known history of HIV, Hepatitis B, or Hepatitis C.I am a male, will not donate sperm, and will follow the study's sex and contraceptive rules.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I agree to use contraception or remain abstinent as required.I am highly allergic to docetaxel or pembrolizumab/vibostolimab.I have lung disease or needed steroids for lung inflammation.You are expected to live for at least 3 more months.My organs are functioning well.I have been treated for an autoimmune disease in the last 2 years.I have given a sample of my tumor for PD-L1 testing.I can be treated again with the same anti-PD-L1 therapy I had before.I have received an organ or tissue transplant from another person.I have been treated with docetaxel alone or with other therapies.My cancer is not suitable for EGFR, ALK, or ROS1 targeted therapy.My cancer has worsened despite treatment with a PD-1/PD-L1 inhibitor.
- Group 1: Arm 2: Pembrolizumab/Vibostolimab coformulation
- Group 2: Arm 3: Placebo + Docetaxel
- Group 3: Arm 1: Pembrolizumab/Vibostolimab coformulation + Docetaxel
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Pembrolizumab/Vibostolimab coformulation received FDA approval?
"Pembrolizumab/Vibostolimab coformulation is currently in Phase 2 of clinical trials. This indicates that, while there is some data supporting its safety, none yet exists to vouch for its efficacy. Therefore, our team has given it a score of 2."
Are we currently looking for people to participate in this experiment?
"Unfortunately, this particular clinical trial is no longer recruiting patients. The study was first posted on April 20th, 2021 and received its last update June 30th, 2022. However, there are still many other trials actively searching for participants that might be a match. For example, there are currently 2036 trials actively searching for participants with carcinoma, non-small-cell lung and 1306 trials for Pembrolizumab/Vibostolimab coformuation actively recruiting patients"
What is the precedent for using this Pembrolizumab/Vibostolimab drug combination?
"Pembrolizumab/Vibostolimab coformuation is being trialed in 1306 different clinical studies, 243 of which are Phase 3 trials. The large number of locations (55567) conducting these trials suggests that this treatment is under significant investigation."
How many patients are being given this opportunity to participate in this research?
"This trial is no longer enrolling patients. The listing was created on April 20th, 2021 and last updated on June 30th, 2022. For those still searching for ongoing trials, there are presently 2036 clinical trials actively enrolling patients with carcinoma, non-small-cell lung and 1306 studies for Pembrolizumab/Vibostolimab coformuation actively recruiting participants."
Could you inform me as to how many hospitals are included in this research project?
"Currently, this clinical trial is enrolling patients at 10 sites. The locations of the centres are in Saint Louis, Springfield and Bronx as well other cities. If you wish to enroll, consider selecting a site that is close to reduce travel time requirements."
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