A 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-715-06/ECHO-306-06)
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Non-small cell lung cancer, programmed cell death 1 (PD-1) inhibitor, indoleamine 2, 3-dioxygenase 1 (IDO1) inhibitor, chemotherapy
Eligibility Criteria
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.
Sites / Locations
- Southern Cancer Center, PC
- Western Regional Medical Center, Inc.
- Arizona Oncology Associates PC- HOPE
- Lynn Cancer Institute
- Florida Cancer Specialists (South Region)
- Florida Cancer Specialists (North Region)
- PPG-Oncology
- University of Michigan
- MMCORC
- St. Vincent Healthcare Frontier Cancer Center
- New York Oncology Hematology P.C
- Oncology Hematology Care, Inc.
- Southwestern Regional Medical Center, Inc.
- St. Luke's Hospital - Anderson Campus
- Allegheny General Hospital
- Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
- Tennessee Oncology, PLLC/The Sarah Cannon Research Institute
- Texas Oncology-Denton South
- Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care
- Emily Couric Clinical Cancer Center
- Seattle Cancer Care Alliance
- MNCCI Port Macquarie Base Hospital
- Blacktown Hospital
- Chris OBrien Lifehouse
- The Crown Princess Mary Cancer Centre Westmead
- Southern Medical Day Care Centre
- Cairns Base Hospital
- BCCA-Cancer Centre of the Southern Interior
- Lions Gate Hospital
- CISSS de la Monteregie-Centre
- CSSS de Laval- Hopital de la Cite de la Sante
- CIUSSS Ouest de l'Ile - St-Mary's Hospital
- CIUSSS du Nord-de-l'ILe-de-Montreal Hopital du Sacre-Coeur de Montreal
- CIUSSS de la Mauricie-et-du-Centre-du-Quebec
- CHU de Quebec - Hotel-Dieu de Quebec
- Zala Megyei Korhaz Pozvai Telephely
- Orszagos Koranyi TBC es Pulmonologiai Intezet
- Veszprem Megyei Tudogyogyintezet
- Bekes Megyei Pandy Kalman Korhaz
- CRU Hungary Kft.
- Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet
- St Vincents University Hospital
- Ha Emek Medical Center
- Soroka Medical Center
- Rambam Medical Center
- Meir Medical Center
- Rabin Medical Center
- Chaim Sheba Medcal Center
- Centro Di Riferimento Oncologico
- A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Istituto Europeo di Oncologia
- Ospedale San Gerardo - ASST Monza
- National Cancer Center
- Severance Hospital Yonsei University Health System
- Asan Medical Center
- Samsung Medical Center
- Medical Care Research S.A. de C.V.
- Oaxaca Site Management Organization S.C.
- FAICIC Clinical Research
- Belgorod Regional Oncology Dispensary
- Udmurtia Republic Regional Clinical Oncology Dispensary
- Republican Clinical Oncology Dispensary of Tatarstan MoH
- Central Clinical Hospital with polyclinic
- Moscow Research Oncology Institute
- SBI of Stavropol region Pyatigorskiy Oncologic dispensary
- SBHI Leningrad Regional Clinical Hospital
- SBHI Samara Regional Clinical Oncology Dispensary
- Oncological Dispensary #2 of Ministry of Health of Krasnodar region
- Tomsk Scientific Research Institute of Oncology
- Hospital Universitario Insular de Gran Canaria
- Hospital Juan Ramón Jimenez
- Institut Catala Oncologia de Bellvitge - ICO
- Hospital Universitario La Paz
- Hospital Universitario La Fe
- Hospital Clinico Universitario Lozano Blesa
- Chang Gung Medical Foundation, Kaohsiung Branch
- China Medical University Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Chang Gung Medical Foundation, Linkou Branch
- Ege Universitesi Tip Fakultesi Hastanesi
- Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi
- Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi
- Hacettepe Universitesi Tip Fakultesi Hastanesi
- Uludag Universitesi Tip Fakultesi
- Pamukkale Unv. Tip Fak
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
- Samsun Medical Park Hastanesi
- Namık Kemal University Medical Faculty
- Mount Vernon Cancer Centre
- Western General Hospital
- North Middlesex Hospital
- Freeman Hospital Newcastle upon Tyne Foundation NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Pembrolizumab + Chemotherapy + Epacadostat
Pembrolizumab + Chemotherapy + Placebo
Pembrolizumab + Epacadostat
Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m^2 IV infusion, Q3W + cisplatin 75 mg/m^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles).
Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, BID in each 21 day cycle for up to 35 cycles.