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Novel Drug Regimens for Lung Cancer
Study Summary
This trial will compare the effectiveness of new regimens of drugs (either given together or as single agents) to the current standard of care in patients with advanced non-small cell lung cancer that has gotten worse despite treatment or come back after treatment. The trial will have two parts. The first part will be an optional part that is not randomized, where patients will be given the new drug to see if it is safe and to generate additional data. The second part will be a randomized, open-label part comparing the efficacy and safety of the new regimens of drugs to the standard of care.
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?
Media Library
- I am a man and will use effective birth control during and for 4 months after treatment.I had a positive response to previous PD(L)1 therapy but my cancer later progressed.I can provide a tissue sample from my lung cancer, either new or from past tests.I have not had major surgery within the last 28 days.I am able to understand and sign the consent form.My lung cancer diagnosis was confirmed through lab tests.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control.I've had radiation but have untreated cancer spots or documented growth after treatment.I have not been on systemic therapy for an infection within the last week.I have had more than 2 treatments for non-small cell lung cancer.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't taken high-dose steroids or immunosuppressants in the last week.I have had a bone marrow or organ transplant in the past.I have not received a live vaccine in the last 30 days.I am 18 years or older, or 19 if I am in Korea.My cancer progressed after treatment for my BRAF mutation.I am fully active or can carry out light work.My organs are functioning well.I have previously been treated with Docetaxel or any investigational drugs in this study.I haven't taken any cancer drugs in the last 30 days or 5 half-lives, whichever is shorter.I have not had any cancer other than my current type in the last 2 years, or if I have, it has been treated and I've been disease-free for 2 years.I haven't had serious heart or unstable liver issues in the last 6 months.I tested positive for hepatitis B recently.I haven't received blood products or specific medications to stimulate blood cell production within the last 14 days.My cancer has worsened after up to 2 treatments, including platinum and PD-L1 therapy.You are expected to live for at least 12 more weeks.You have had a serious allergic reaction to the study drug or any of its ingredients.I am not on strong medication affecting liver enzymes.
- Group 1: Part 2: Participants receiving feladilimab and docetaxel
- Group 2: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug
- Group 3: Part 1: Participants receiving dostarlimab plus GSK4428859A/EOS884448/belrestotug plus GSK6097608
- Group 4: Part 2: Participants receiving SoC: docetaxel
- Group 5: Part 1: Participants receiving feladilimab and ipilimumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the toxicity profile of GSK4428859A?
"GSK4428859A falls into the Phase 2 category, meaning that while there is some data suggesting it is safe, there is no evidence yet of its efficacy. Our team scored it a 2."
Is this study still looking for participants?
"Indeed, the listed information on clinicaltrials.gov affirms that this trial is presently recruiting patients. Originally posted on January 24th, 2019 and last edited on November 6th, 2022; this study is looking for 185 individuals at 10 different locations."
Could you tell us how many hospitals are a part of this research project?
"Right now, this clinical trial is being conducted in 10 locations. They are situated in Southfield, Ottawa and Edmonton as well as 7 other cities. If you want to enroll in the study, it would be best to choose a clinic close to your residence to limit travel complications."
What are the benefits of GSK4428859A?
"GSK4428859A is a medication used to treat bladder cancer that has spread, as well as other diseases such as small cell lung cancer (sclc), cutaneous melanoma, and advance directives."
What is the research history of GSK4428859A?
"At the moment, there are 768 clinical trials studying GSK4428859A with 182 of them in Phase 3. Most of these studies are based in Pittsburgh, Pennsylvania; however, there are 46769 locations running studies for GSK4428859A."
How many guinea pigs are there in this clinical trial?
"That is correct. The online information available on clinicaltrials.gov affirms that this trial is currently searching for patients to participate. This trial was first posted on January 24th, 2019 and has been edited as recently as November 6th, 2020. 185 participants are needed in total from 10 different locations."
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