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Sargramostim + Pembrolizumab for Non-Small Cell Lung Cancer
Study Summary
This trial is important because it seeks to improve response rates in first-line treatments for patients with stage 4 NSCLC without genetically targetable alterations, especially in those patients with PDL-1 <50%.
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 have brain metastases that have not been treated.You have at least one lesion that can be measured according to specific guidelines.I am eligible for a specific cancer treatment plan including pembrolizumab.I have received a solid organ transplant.My lung cancer is at an advanced stage and cannot be treated with chemoradiation.I am 18 years old or older.You currently have a condition where your immune system attacks your own body.You are expected to live for at least 3 more months.I am fully active or can carry out light work.I can give myself daily injections.I have an active lung condition.You are allergic to GM-CSF (sargramostim).My cancer's PDL-1 level is between 1% and 49%.I am currently taking steroids or other drugs that weaken my immune system.I have never received immunotherapy.
- Group 1: GM-CSF Plus Maintenance Pembrolizumab +/- Pemetrexed
- 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
Are any slots currently available for participants in this trial?
"This medical study, which was initially announced on March 1st 2022, is still searching for participants according to clinicaltrials.gov; the trial's information was last changed on October 3rd of this year."
What is the primary focus of this experiment?
"This clinical trial will assess Progression Free Survival (PFS) over a two year period as its primary outcome. Secondary endpoints include measuring myeloid derived suppressor cells, PD-1+ CD4 levels and CD4 T activity at different intervals during treatment."
How is Pembrolizumab commonly employed to aid patients?
"Pembrolizumab is frequently utilized to treat malignant neoplasms, such as unresectable melanoma and microsatellite instability high. Moreover, it can be employed to address locally advanced nonsquamous non-small cell lung cancer."
Could you explain the potential detriments of Pembrolizumab to patients?
"Our Power team evaluation of Pembrolizumab's safety is a 2, as the Phase 2 trial has provided data confirming its security yet not fully established its efficacy."
How many participants are actively enrolled in this research investigation?
"Affirmative. Per the information accessible on clinicaltrials.gov, this medical research project is currently looking for enrollees. The trial was first launched in January 3rd 2022 and has been updated as of October 3rd 2022; 83 patients are needed at a single site."
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