Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC
a study on Lung Cancer
This 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 2 years: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 2 years. 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 2 years.
Randomized 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
While a genotype-directed strategy has been established as effective in treatment selection for patients with advanced NSCLC, only a minority of patients at this time will have a readily identifiable actionable molecular target. Furthermore, genotype-directed therapy has not been validated for patients with squamous cell carcinoma of the lung. Therefore, the majority of patients with advanced NSCLC will continue to rely on standard platinum-based doublet chemotherapy. Given the plateau in effectiveness of this approach, novel treatment strategies are clearly warranted.
Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Paclitaxel Pembrolizumab Albumin-Bound Paclitaxel Carboplatin Pemetrexed MK-3475
You can join if…
Open to people ages 18 years and up
- Be ≥ 18 years of age on day of signing informed consent.
- Have a life expectancy of at least 3 months.
- Have a histologically or cytologically confirmed diagnosis of stage IV NSCLC.
- Have a performance status of 0 or 1 on the ECOG.
- Have a measurable disease based on RECIST 1.1.
- Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of tumor lesion.
- 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.
- Demonstrate adequate organ function.
- Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours.
- . Female parents of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile.
- . Male patients must agree to use an adequate method of contraception.
You CAN'T join if...
- Has received prior treatment with chemotherapy or biologic therapy for stage IV NSCLC.
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy.
- Has had a prior mAb within 4 weeks prior to study Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Has had prior chemotherapy or radiation.
- Has a known additional malignancy that is progressing or requires active treatment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- . Has an active infection requiring systemic therapy.
- . Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial.
- . Has known psychiatric or substance abuse disorders.
- . Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
- . Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody.
- . Has a known history of HIV.
- . Has known active Hepatitis B or Hepatitis C.
- . Has received a live vaccine within 30 days prior to the planned first dose of study therapy.
- . Has a known history of active TB.
- . Hypersensitivity to pembrolizumab or any of it's excipients.
- UCSD Moores Cancer Center accepting new patients
La Jolla California 92093 United States
- University of Oklahoma Health Sciences Center Stephenson Cancer Center accepting new patients
Oklahoma City Oklahoma 73104 United States
- Nebraska Methodist Hospital accepting new patients
Omaha Nebraska 68114 United States
- Medical Oncology & Hematology Associates accepting new patients
Des Moines Iowa 50309 United States
- University of Missouri - Ellis Fischel Cancer Center accepting new patients
Columbia Missouri 65212 United States
- accepting new patients
- Start Date
- Completion Date
- Alliance Foundation Trials, LLC.
- Phase 2
- Study Type
- Last Updated
- April 11, 2018
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.