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 |
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).
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
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3550 Jerome Avenue
Bronx, New York 10467
Bronx, New York 10467
(718) 920-4321
![Montefiore Medical Center](/wp-content/uploads/logos/montefiore-medical-center.gif)
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
Santa Monica, California 90404
(310) 582-7438
![John Wayne Cancer Institute](/wp-content/uploads/logos/jwayne.gif)
Phone: 310-582-7249
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Berazategui, Buenos Aires
Phone: +541142262013
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Billings, Montana 59102
Phone: 406-238-6290
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3701 Algonquin Road
Elk Grove Village, Illinois 60007
Elk Grove Village, Illinois 60007
Phone: 847-640-5605
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Harrisburg, Pennsylvania 17109
Phone: 717-724-6765
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Lansing, Michigan 48912
Phone: 517-364-2835
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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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Stanford, California 94305
Phone: 650-736-7221
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