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SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer
Study Summary
This trial will compare SC MK-3475A to IV pembrolizumab as first-line treatment for metastatic non-small cell lung cancer, assessing safety & how drugs are processed by the body.
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 have another cancer that is getting worse or was treated in the last 3 years.I am currently being treated for an infection.I have not had cancer treatment or been in a cancer study in the last 4 weeks.I have received an organ or tissue transplant from another person.I have a history of HIV infection.I am still recovering from major surgery or have ongoing complications.I have had Hepatitis B or C.I have received treatment for my advanced lung cancer.I have an immune system disorder or am on long-term steroids.You are expected to live for at least 3 more months.My lung cancer is confirmed as NSCLC through tests.I have been diagnosed with small cell lung cancer.I haven't had radiotherapy in the last 2 weeks or need steroids for radiation side effects.I have not had a live vaccine in the last 30 days.I can provide a sample of my tumor that hasn't been treated with radiation.I have had lung radiation therapy of more than 30 Gray in the last 6 months.I have been treated for an autoimmune disease in the last 2 years.
- Group 1: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
- Group 2: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
- 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
Has the combination of MK-3475A and Platinum Doublet Chemotherapy been granted endorsement by the FDA?
"Our evaluation at Power concluded that Arm 1 (MK-3475A + Platinum Doublet Chemotherapy) is safe, scoring it a 3 on our scale. This comes from the evidence gathered in Phase 3 trials of efficacy and safety data."
What is the aggregate number of individuals enrolled in this experiment?
"This study necessitates the enrolment of 339 individuals who meet its criteria for inclusion. Patients can take part from sites such as Mid Florida Hematology and Oncology Center (Site 0010) in Orange City, Florida or Changhua Christian Hospital ( Site 4203) in Changhua County, Changhua."
Is this investigation still enrolling participants?
"Clinicaltrials.gov provides evidence that this medical trial is currently enrolling patients. The initial posting was made on February 14th 2023 and the details were last modified two weeks later, on February 28th 2023."
What objectives is this experiment attempting to accomplish?
"This trial will measure the Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State for up to 27 months. Secondary desired outcomes include Progression-free Survival (PFS), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event, and Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs)."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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