Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:April 24, 2018
End Date:June 29, 2026
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination
with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase],
followed by pembrolizumab alone after surgery [adjuvant phase] in participants with
resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). The primary hypotheses of
this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed
by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival
(EFS) by biopsy assessed by blinded central pathologist or by imaging using Response
Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent
central review (BICR); and 2) overall survival (OS).


Inclusion Criteria:

- Have previously untreated, histologically confirmed NSCLC and histologically confirmed
Stage IIB or IIIA NSCLC.

- Be able to undergo protocol therapy, including necessary surgery.

- If male, must agree to use contraception or practice abstinence as well as refrain
from donating sperm for at least 180 days after the last dose of study treatment.

- If female, may participate if not pregnant, not breastfeeding, and at least one of the
following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a
WOCBP who agrees to follow contraceptive guidance during the treatment period and for
at least 180 days after the last dose of study treatment.

- Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for
submission. If blocks are not available, have unstained slides for submission for
central programmed death-ligand 1 (PD-L1) testing.

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within
10 days of randomization.

- Have adequate organ function.

Exclusion Criteria:

- A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose
of study treatment.

- Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus;
2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.

- Has a history of (non-infectious) pneumonitis /interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease that requires steroids.

- Has an active infection requiring systemic therapy.

- Has had an allogenic tissue/sold organ transplant.

- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance
and/or any of its excipients.

- Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy
agents and/or to any of their excipients.

- Has an active autoimmune disease that has required systemic treatment in past 2 years.

- Has a known history of human immunodeficiency virus (HIV) infection.

- Has a known history of Hepatitis B or Hepatitis C.

- Has a known history of active tuberculosis.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the participant's
participation for the full duration of the trial, or is not in the best interest of
the participant to participate.

- Has known psychiatric or substance abuse disorders that would interfere with
cooperating with the requirements of the trial.

- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with
an agent directed to another co-inhibitory T-cell receptor.

- Has received prior systemic anti-cancer therapy including investigational agents for
the current malignancy prior to randomization/allocation.

- Has received prior radiotherapy within 2 weeks of start of trial treatment.

- Has received a live vaccine within 30 days prior to the first dose of trial drug.

- Is currently participating in or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
trial treatment.

- Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or
any other form of immunosuppressive therapy within 7 days prior the first dose of
trial drug.

- Has a known additional malignancy that is progressing or requires active treatment
within the past 5 years.

- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 180 days
after the last dose of trial treatment.
We found this trial at
33
sites
Worcester, Massachusetts 01605
Phone: 508-856-3216
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 718-405-8344
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
Phone: 310-582-7249
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Albany, New York 12208
Phone: 518-525-6418
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Anaheim, California 92801
Phone: 7149991465230
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Ashland, Kentucky 41101
Phone: 606-836-0202
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Berazategui, Buenos Aires
Phone: +541142262013
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Billings, Montana 59102
Phone: 406-238-6290
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Charlottesville, Virginia 22903
Phone: 434-297-7784
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Detroit, Michigan 48202
Phone: 313-916-3721
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3701 Algonquin Road
Elk Grove Village, Illinois 60007
Phone: 847-640-5605
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Fairfax, Virginia 22031
Phone: 703-970-6447
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11141 Parkview Plaza Drive
Fort Wayne, Indiana 46845
Phone: 260-425-6800
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Gilbert, Arizona 85234
Phone: 480-256-3425
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Goodyear, Arizona 85338
Phone: 623-207-3899
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Harrisburg, Pennsylvania 17109
Phone: 717-724-6765
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Phone: 708-915-6119
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Iowa City, Iowa 52242
Phone: 319-384-5461
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Jacksonville, Florida 32216
Phone: 904-953-2000
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Lansing, Michigan 48912
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Monterey, California 93940
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Newark, Delaware 19713
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Newnan, Georgia 30265
Phone: 770-400-6036
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-8711
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Philadelphia, Pennsylvania 19124
Phone: 215-537-6438
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Pittsburgh, Pennsylvania 15240
Phone: 412-360-3653
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
Phone: 507-538-1665
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Santa Rosa, California 95403
Phone: 707-521-3830
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Stanford, California 94305
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Stony Brook, New York 11794
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Tulsa, Oklahoma 74133
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White Plains, New York 10601
Phone: 914-849-7630
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