Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2016
End Date:December 2019
Contact:Ed Habermehl
Email:info@alliancefoundationtrials.org

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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

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.

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.

Inclusion Criteria:

1. Be ≥ 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.

Exclusion Criteria:

1. Has received prior treatment with chemotherapy or biologic therapy for stage IV NSCLC.

2. Is currently participating in or has participated in a study of an investigational
agent or using an investigational device.

3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy.

4. 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.

5. Has had prior chemotherapy or radiation.

6. Has a known additional malignancy that is progressing or requires active treatment.

7. Has known active CNS metastases and/or carcinomatous meningitis.

8. 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.

9. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.

10. Has an active infection requiring systemic therapy.

11. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial.

12. Has known psychiatric or substance abuse disorders.

13. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial.

14. Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
CTLA-4 antibody.

15. Has a known history of HIV.

16. Has known active Hepatitis B or Hepatitis C.

17. Has received a live vaccine within 30 days prior to the planned first dose of study
therapy.

18. Has a known history of active TB.

19. Hypersensitivity to pembrolizumab or any of it's excipients.
We found this trial at
19
sites
8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Robert Langdon
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Katherine Scilla
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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33 Whiting Hill Road
Brewer, Maine 04412
Principal Investigator: Antoine Harb
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jyoti Patel
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Columbia, Missouri 65203
Principal Investigator: Puja Nistala
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Columbia, MO
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Gregory Otterson
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Concord, New Hampshire 03301
Principal Investigator: Douglas Weckstein
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Des Moines, Iowa 50309
Principal Investigator: Robert Behrens
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East Syracuse, New York 13057
Principal Investigator: Jeffrey Kirshner
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Evanston, Illinois
Principal Investigator: Thomas Hensing
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Evanston, IL
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Hooksett, New Hampshire 03106
Principal Investigator: Douglas Weckstein
Phone: 603-622-6484
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La Jolla, California 92093
Principal Investigator: Lyudmila Bazhenova
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Konstantin Dragnev
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Minneapolis, Minnesota 55416
Principal Investigator: Arkadiusz Dudek
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Minneapolis, MN
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Oklahoma City, Oklahoma 73104
Principal Investigator: Raid Aljumaily
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Principal Investigator: Bryan Faller
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Stephen Graziano
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West Columbia, South Carolina 29169
Principal Investigator: James Wells
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Winston-Salem, North Carolina 27157
Principal Investigator: William Petty
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