Phase
Condition
N/ATreatment
fianlimab
Placebo
cemiplimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIICdisease who are not candidates for surgical resection or definitive chemoradiationper investigator assessment or stage IV (metastatic disease), who received no priorsystemic treatment for recurrent or metastatic NSCLC.
Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE)tumor tissue sample, without intervening therapy between biopsy collection andscreening as described in the protocol
For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as determined bya College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accreditedlaboratory, as described in the protocol. For enrollment in phase 3, patients shouldhave expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cellsstained using an assay performed by a central laboratory, as described in theprotocol.
At least 1 radiographically measurable lesion by computed tomography (CT) ormagnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumorsversion 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previouslyirradiated field if there is documented (radiographic) disease progression in thatsite.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
Adequate organ and bone marrow function, as described in the protocol.
Exclusion
Key Exclusion Criteria:
Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
Active or untreated brain metastases or spinal cord compression. Patients areeligible if central nervous system (CNS) metastases are adequately treated, andpatients have neurologically returned to baseline (except for residual signs orsymptoms related to the CNS treatment) for at least 2 weeks prior to enrollment.Patients must be off (immunosuppressive doses of) corticosteroid therapy.
Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, orc-ros oncogene 1 (ROS1) fusions, as described in the protocol.
Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
History of interstitial lung disease (eg, idiopathic pulmonary fibrosis ororganizing pneumonia), of active, noninfectious pneumonitis that requiredimmune-suppressive doses of glucocorticoids to assist with management, or ofpneumonitis within the last 5 years. A history of radiation pneumonitis in theradiation field is permitted as long as pneumonitis resolved ≥6 months prior toenrollment.
Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome,T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cellimmunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome,ataxia telangiectasia, common variable immunodeficiency).
Ongoing or recent (within 2 years) evidence of significant autoimmune disease thatrequired treatment with systemic immunosuppressive treatments, which may suggestrisk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients withuncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency areexcluded. The following are not exclusionary: vitiligo, childhood asthma that hasresolved, residual hypothyroidism that required only hormone replacement, orpsoriasis that does not require systemic treatment.
Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day orequivalent) within 14 days of randomization. Physiologic replacement doses areallowed even if they are >10 mg of prednisone/day or equivalent, as long as they arenot being administered for immunosuppressive intent. Patients with clinicallyrelevant systemic immune suppression within the last 3 months before trialenrollment are excluded. Inhaled or topical steroids are permitted, provided thatthey are not for treatment of an autoimmune disorder.
Patients who have received prior systemic therapies are excluded with the exceptionof the following:
Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgeryand/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAEgrade ≤1 or baseline with the exception of alopecia and peripheral neuropathy.
Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy aslong as the last dose is >12 months prior to enrollment.
Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant orneoadjuvant therapy, Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4)antibodies as long as the last dose is >6 months prior to enrollment.Immune-mediated AEs must be resolved to CTCAE grade ≤1 or baseline by the timeof enrollment. Endocrine immune-mediated AEs controlled with hormonal or othernon-immunosuppressive therapies without resolution prior to enrollment areallowed.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Study Design
Connect with a study center
Macquarie University Health Science Center (MQ Health)
Macquarie Park, New South Wales 2109
AustraliaActive - Recruiting
Riverina Cancer Care Centre (RCCC)
Wagga Wagga, New South Wales 2650
AustraliaActive - Recruiting
Southern Medical Day Care Centre
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
Ballarat Regional Integrated Cancer Centre (BRICC)
Ballarat, Victoria 3350
AustraliaActive - Recruiting
Bendigo Hospital
Bendigo, Victoria 3550
AustraliaActive - Recruiting
British Columbia Cancer Center- Kelowna
Kelowna, British Columbia V1Y 5L3
CanadaActive - Recruiting
LTD Cancer Center of Adjara
Batumi, Adjaria 6000
GeorgiaActive - Recruiting
Israeli Georgian medical research clinic Helsicore
Tbilisi, 0112
GeorgiaActive - Recruiting
JSC Evex Hospitals- Caraps Medline
Tbilisi, 179
GeorgiaActive - Recruiting
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159
GeorgiaActive - Recruiting
Research Institute of Clinical Medicine
Tbilisi, 112
GeorgiaActive - Recruiting
TIM - Tbilisi Institute of Medicine
Tbilisi, 0160
GeorgiaActive - Recruiting
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 144
GeorgiaActive - Recruiting
The Institute of Clinical Oncology
Tbilisi, 0159
GeorgiaActive - Recruiting
Soroka University Medical Center
Beer-Sheba, HaDarom 84101
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Assuta Medical Centers
Tel Aviv, 6971028
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelActive - Recruiting
Chungbuk National University Hospital
Cheongju-si, Chungbuk 28644
Korea, Republic ofActive - Recruiting
Ajou University Hospital
Suwon, Gyeonggi 16499
Korea, Republic ofActive - Recruiting
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do 54907
Korea, Republic ofActive - Recruiting
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofActive - Recruiting
Inha University Hospital
Incheon, 22332
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 8308
Korea, Republic ofActive - Recruiting
St. Vincent's Hospital, The Catholic University of Korea
Suwon, 16247
Korea, Republic ofActive - Recruiting
Ulsan University Hospital
Ulsan, 44033
Korea, Republic ofActive - Recruiting
Hospital Sultan Ismail
Johor Bahru, Johor 81100
MalaysiaActive - Recruiting
Hospital Tengku Ampuan Afzan (HTTA)
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan 50586
MalaysiaActive - Recruiting
National Cancer Institute
Putrajaya, Wilayah Persekutuan 62250
MalaysiaActive - Recruiting
Hospital Pulau Pinang
Pulau Pinang, 10990
MalaysiaActive - Recruiting
Hualien Tzu Chi Medical Center
Hualien, 97002
TaiwanSite Not Available
Hualien Tzu Chi Medical Center
Hualien City, 97002
TaiwanActive - Recruiting
Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Medical University Hospital
Taipei, 110301
TaiwanActive - Recruiting
Navamindradhiraj University
Dusit, Bangkok 10300
ThailandActive - Recruiting
Chiang Mai University
Muang, Chiang Mai 50200
ThailandActive - Recruiting
Prince Of Songkla Hospital, Prince Of Songkhla University
Hat-Yai, Songkhla 90110
ThailandActive - Recruiting
Lampang Cancer Center
Lampang, 52000
ThailandActive - Recruiting
Istinye University VMMedical Park Pendik Hospital
Pendik, Istanbul 34899
TurkeyActive - Recruiting
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Meram 42080
TurkeyActive - Recruiting
Ondokuz Mayis University
Kurupelit, Samsun 55139
TurkeyActive - Recruiting
Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil 27584
TurkeyActive - Recruiting
Gazi University
Ankara, 06100
TurkeyActive - Recruiting
Gulhane Research and Training Hospital
Ankara, 06010
TurkeyActive - Recruiting
Liv Hospital Ankara
Ankara, 06100
TurkeyActive - Recruiting
Memorial Ankara Hospital
Ankara, 906520
TurkeyActive - Recruiting
Sbu Dr.A.Y. Ankara Onkoloji Suam
Ankara, 06100
TurkeyActive - Recruiting
Yuksek Ihtisas Unıversity Medicalpark Hospital
Ankara, 06370
TurkeyActive - Recruiting
Trakya University
Edirne, 22030
TurkeyActive - Recruiting
Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
Istanbul, 81450
TurkeyActive - Recruiting
Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, 34450
TurkeyActive - Recruiting
Koc University
Istanbul, 34010
TurkeyActive - Recruiting
Izmir Economy University Medical Point Hospital
Izmir, 35325
TurkeyActive - Recruiting
Arizona Clinical Research Center
Tucson, Arizona 85715
United StatesActive - Recruiting
Yuma Regional Medical Center
Yuma, Arizona 85364
United StatesActive - Recruiting
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California 92270
United StatesActive - Recruiting
Emad Ibrahim, MD, Inc.
Redlands, California 92373
United StatesActive - Recruiting
Clermont Oncology Center
Clermont, Florida 34711
United StatesActive - Recruiting
Clerrmont Oncology Center
Clermont, Florida 34711
United StatesActive - Recruiting
Miami Veterans Administration HealthCare System
Miami, Florida 33125
United StatesActive - Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United StatesActive - Recruiting
Pinellas Hematology and Oncology
Saint Petersburg, Florida 33709
United StatesActive - Recruiting
Tallahassee Memorial Healthcare
Tallahassee, Florida 32308
United StatesActive - Recruiting
University of Illinois
Chicago, Illinois 60612
United StatesActive - Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United StatesActive - Recruiting
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United StatesActive - Recruiting
Capital Health Medical Center
Pennington, New Jersey 08534
United StatesActive - Recruiting
New Mexico Cancer Care Alliance/ University of New Mexico
Albuquerque, New Mexico 87131-0001
United StatesActive - Recruiting
New York Cancer and Blood Specialists
Port Jefferson Station, New York 11776
United StatesActive - Recruiting
Clinical Research Alliance, Inc.
Westbury, New York 11590
United StatesActive - Recruiting
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesActive - Recruiting
Thompson Cancer Survival Center (TCSC ) - Downtown
Knoxville, Tennessee 37916-2300
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Renovatio Clinical
El Paso, Texas 79915
United StatesActive - Recruiting
University of Virginia Medical Center
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Bon Secours Cancer Institute Richmond
Midlothian, Virginia 23114
United StatesActive - Recruiting
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