Keynote 789
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.
The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.
CLINICALTRIALS.GOV IDENTIFIER:
NCT03515837
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.
50% will receive pembrolizumab along with pemetrexed and carboplatin* or cisplatin*
50% will receive placebo along with pemetrexed and carboplatin* or cisplatin*
*
*Your doctor will decide which chemotherapy treatment (carboplatin or cisplatin) is best for you.
Neither you nor the study doctor will know what group you are assigned. You will not know if you are receiving pembrolizumab or placebo.
In case of a health emergency, the study doctor can get this information.
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.
Print this page or email it to your doctor to discuss at your next visit.
CLINICALTRIALS.GOV IDENTIFIER:
NCT03515837
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.
Print this page
Email this page