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Pembrolizumab + Chemotherapy for Lung Cancer
Study Summary
This trial is studying whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with advanced non-squamous non-small cell lung cancer.
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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- I am fully active or restricted in physically strenuous activity but can do light work.I took low-dose Methotrexate for a non-cancer condition and stopped at least 14 days ago.My hepatitis B is under control or I am cured of hepatitis C.I will follow guidelines for fluid drainage if treated with pemetrexed.My cancer shows a PD-L1 level of 1% or more.My heart is healthy and I haven't had serious heart disease or treatments that could harm my heart.My lung cancer is advanced but not squamous, and I can't have chemo and radiation together.My brain cancer hasn't worsened after treatment and I don't need immediate brain-specific treatment.I am taking medication to control seizures.I am taking medication to control seizures.My blood clotting time is within safe limits while on blood thinners.I am not pregnant or breastfeeding and have confirmed this with a test.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I don't have any serious illnesses that could affect my safety or the study's results.I have another cancer, but it won't affect this trial's treatment.I haven't taken steroids for at least 14 days.My brain cancer is stable after treatment, and I don't need immediate brain-specific treatment.My cancer can be measured by tests or seen on scans, taken within the last 4 weeks.I have NSCLC but haven't had checkpoint inhibitors for it. I've waited the required time after any previous treatments.I haven't needed treatment for an autoimmune disease in the last 2 years.I have advanced non-squamous NSCLC and cannot have combined chemo and radiation.I am not pregnant or breastfeeding and have confirmed this with a test.I haven't had a live vaccine in the last 30 days.I am 18 years old or older.You need to have a certain number of a type of white blood cells called neutrophils in your blood.Your platelet count is at least 100,000 per cubic millimeter within the last 14 days before the study starts.My cancer shows a PD-L1 level of 1% or more.I am receiving radiation for symptom relief from bone metastasis.I am taking medication to control seizures.I have small brain metastases not requiring immediate treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be measured by tests or seen on scans.I am receiving radiation for symptom relief on bone metastasis.My cancer shows a PD-L1 level of 1% or more.My cancer does not have treatable mutations like EGFR (except exon 20), BRAF (V600), ALK, or ROS1.I will use or am using effective birth control or abstaining from sex during and for 120 days after treatment.If I receive pemetrexed, I will follow guidelines to drain fluids.I haven't taken steroids for at least 14 days.I do not have major GI issues like Crohn's disease causing diarrhea.Your liver function test results are within a certain range.Your kidney function, measured by a blood test, needs to be within a certain range.My cancer can be measured by tests or seen on scans, done within the last 4 weeks.I haven't taken steroids or immunosuppressants in the last 7 days.I do not have an active tuberculosis infection.I am 18 years old or older.I do not have a history of lung conditions that needed steroids.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I do not have any serious illnesses that could affect my safety or interfere with the study.I have advanced non-squamous NSCLC and cannot have chemo and radiation together.Your liver function test results must show that your SGPT (ALT) levels are not more than 5 times the upper limit of normal.My cancer shows a PD-L1 level of 1% or more.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.Your total bilirubin level must be less than or equal to 1.5 mg/dL within 14 days before starting the study.My kidney function is good enough for certain cancer treatments.
- Group 1: Arm B (pembrolizumab, pemetrexed, carboplatin)
- Group 2: Arm A (pembrolizumab, pemetrexed, carboplatin)
- Group 3: Arm C (pembrolizumab, pembrolizumab, carboplatin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 type of illnesses or diseases is Pembrolizumab mostly effective for?
"Pembrolizumab is an immunotherapy medication that can be used to treat various types of cancer, such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."
What does the existing literature say about Pembrolizumab?
"Pembrolizumab is being trialed in 1664 different ongoing studies, with 337 of those in Phase 3. Though many of these trials are based in Shanghai, there are 74921 total locations for these trials."
What is the general consensus on Pembrolizumab's effectiveness?
"Pembrolizumab has received a safety score of 3. This is because it is a Phase 3 trial, which means that there is not only data supporting its efficacy, but also multiple rounds of data affirming its safety."
Are people with this condition still able to enroll in the trial at this time?
"That is correct, according to the information available on clinicaltrials.gov, this clinical trial is still recruiting participants. The study was originally posted on 2/28/2019, and the most recent edit was on 11/3/2022. They are hoping to enroll 846 participants from 100 different locations."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Alegent Health Mercy Hospital: < 48 hours
Average response time
- < 2 Days
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