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Protocol No.1629GCCPrincipal InvestigatorZandberg, Dan
PhasePhase II
Age GroupAdult
TitleRandomized Phase II Trial Evaluating the Optimal Sequencing of PD-1 Inhibition with Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in Patients with Chemotherapy Naive stage IV Non-small Cell Lung Cancer
DescriptionThis is a multicenter randomized phase II to determine if the administration of standard platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475 administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to 1 year: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 1 year. Pembrolizumab every 3 weeks x 4 cycles followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 1 year.
TreatmentCarboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab (MK-3475) every 3 weeks for up to 1 year. Pembrolizumab (MK-3475) every 3 weeks x 4 cycles followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 1 year.
Key EligibilityInclusion Criteria:
1.Be greater than or equal to 18 years of age on day of signing informed consent.
2.Have a life expectancy of at least 3 months.
3.Have a histologically or cytologically confirmed diagnosis of stage IV NSCLC.
4.Have a performance status of 0 or 1 on the ECOG.
5.Have a measurable disease based on RECIST 1.1.
6.Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of tumor lesion.
7.In patients with non-squamous non-small cell lung cancer, investigators must be able to produce source documentation of the EGFR mutation status or ALK translocation status.
8.Demonstrate adequate organ function.
9.Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours.
10.Female parents of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile.
11.Male patients must agree to use an adequate method of contraception.
Applicable Disease SitesLung
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Drugs InvolvedMK-3475
PACLITAXEL
Pemetrexed
Taxol (PACLITAXEL)
carboplatin
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02591615
ContactGreenebaum Cancer Center Maha Khalil, PhD Phone:410-328-5009
Pager:
Email:mkhalil@umm.edu
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