Randomized Phase 2 Study of Pembrolizumab Plus Epacadostat With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)
Status: | Active, not recruiting |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/9/2019 |
Start Date: | December 21, 2017 |
End Date: | September 2021 |
A Randomized Phase 2 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer (KEYNOTE-715-05/ECHO-306-05)
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus
epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based
chemotherapy plus placebo as first-line therapy in participants with metastatic non-small
cell lung cancer (NSCLC).
epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based
chemotherapy plus placebo as first-line therapy in participants with metastatic non-small
cell lung cancer (NSCLC).
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of stage IV NSCLC without
epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic
lymphoma kinase (ALK) translocation
- Measurable disease based on RECIST 1.1
- Life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function per protocol-defined criteria.
- Provide tumor tissue sample.
Exclusion Criteria:
- Known untreated central nervous system metastases and/or carcinomatous meningitis
- History of (non-infectious) pneumonitis that required systemic steroids or current
pneumonitis/interstitial lung disease.
- Symptomatic ascites or pleural effusion.
- Known history of an additional malignancy, except if the participant has undergone
potentially curative therapy with no evidence of that disease recurrence for 5 years
since initiation of that therapy.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Has had an allogeneic tissue/solid organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is
not required unless mandated by the local health authority.
- Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has
active Hepatitis C (HCV RNA). Note: Testing must be performed to determine
eligibility.
- History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's
opinion, is clinically meaningful.
- Use of protocol-defined prior/concomitant therapy.
We found this trial at
21
sites
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222
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Phone: 206-288-7445
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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Billings, Montana 59102
Phone: 406-238-6290
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2600 Research Center Drive
Blacksburg, Virginia 24060
Blacksburg, Virginia 24060
Phone: 281-863-4643
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Chattanooga, Tennessee 37404
Phone: 877-691-7274
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3840 Broadway
Fort Myers, Florida 33901
Fort Myers, Florida 33901
Phone: 239-274-9930
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320 E North Ave
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Phone: 412-578-5393
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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1201 5th Avenue North
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Phone: 727-216-1143
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