Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC
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 CancerLung NeoplasmsCarcinoma, Non-Small-Cell LungPaclitaxelAlbumin-Bound PaclitaxelCarboplatinPembrolizumabPemetrexedMK-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 JollaCalifornia92093United States
- University of Oklahoma Health Sciences Center Stephenson Cancer Center
accepting new patients
Oklahoma CityOklahoma73104United States
- accepting new patients
- Start Date
- Completion Date
- Alliance Foundation Trials, LLC.
- Phase 2
- Study Type
- Last Updated
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