keynote A86
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.
Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
CLINICALTRIALS.GOV IDENTIFIER:
NCT04956692
When speaking to your doctor, please have the trial identifier number available.
All patients who enroll in the trial will receive medication while on the study.
66% will receive pembrolizumab given as a shot under the skin (subcutaneously) with chemotherapy
33% will receive pembrolizumab given through a vein (intravenously) with chemotherapy
*The type of chemotherapy you will get depends on the type of NSCLC you have, squamous or non-squamous.66
Tests the medicine or vaccine in approximately 1,000 to 5,000 volunteers. For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics or physician offices.
Dates
Conditions
Non-small Cell Lung Cancer
Age Range
18 - No Age Maximum
Sex
All
If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible.
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CLINICALTRIALS.GOV IDENTIFIER:
NCT04956692
When speaking to your doctor, please have the trial identifier number available.
Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.
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