Trial Title:
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT ID:
NCT05785767
Condition:
Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cemiplimab
Conditions: Keywords:
Treatment naïve
NSCLC
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
fianlimab
Description:
Every three weeks (Q3W) as intravenous (IV) co-infusion
Arm group label:
A: fianlimab+cemiplimab
Arm group label:
B: fianlimab+cemiplimab
Other name:
REGN3767
Intervention type:
Drug
Intervention name:
cemiplimab
Description:
Q3W as IV co-infusion
Arm group label:
A: fianlimab+cemiplimab
Arm group label:
B: fianlimab+cemiplimab
Arm group label:
C: cemiplimab monotherapy+placebo
Other name:
REGN2810
Other name:
Libtayo
Intervention type:
Drug
Intervention name:
Placebo
Description:
Q3W as IV co-infusion
Arm group label:
C: cemiplimab monotherapy+placebo
Summary:
This study is researching an experimental drug called fianlimab (also called REGN3767),
combined with a medication called cemiplimab (also called REGN2810), individually called
a "study drug" or collectively called "study drugs". The study is focused on patients who
have advanced non-small cell lung cancer (NSCLC).
The aim of the study is to see how effective the combination of fianlimab and cemiplimab
is in treating advanced NSCLC, in comparison with cemiplimab by itself.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much study drug is in your blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drug
less effective or could lead to side effects)
- How administering the study drugs might improve your quality of life
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC
disease who are not candidates for surgical resection or definitive chemoradiation
per investigator assessment or stage IV (metastatic disease), who received no prior
systemic treatment for recurrent or metastatic NSCLC.
2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE)
tumor tissue sample, without intervening therapy between biopsy collection and
screening as described in the protocol
3. For enrollment in phase 2, patients should have PD-L1 levels ≥ 50%, as determined by
a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments
(CLIA) (or equivalently licensed, according to local regulations) accredited
laboratory, as described in the protocol. For enrollment in phase 3, patients should
have expression of programmed cell death ligand-1 (PD-L1) in ≥50% of tumor cells
stained using an assay performed by a central laboratory, as described in the
protocol.
4. At least 1 radiographically measurable lesion by computed tomography (CT) or
magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors
version 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previously
irradiated field if there is documented (radiographic) disease progression in that
site.
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
6. Adequate organ and bone marrow function, as described in the protocol.
Key Exclusion Criteria:
1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression. Patients are
eligible if central nervous system (CNS) metastases are adequately treated, and
patients have neurologically returned to baseline (except for residual signs or
symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment.
Patients must be off (immunosuppressive doses of) corticosteroid therapy.
3. Patients with tumors tested positive for actionable epidermal growth factor receptor
(EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or
c-ros oncogene 1 (ROS1) fusions, as described in the protocol.
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment.
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or
organizing pneumonia), of active, noninfectious pneumonitis that required
immune-suppressive doses of glucocorticoids to assist with management, or of
pneumonitis within the last 5 years. A history of radiation pneumonitis in the
radiation field is permitted as long as pneumonitis resolved ≥6 months prior to
enrollment.
6. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome,
T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell
immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome,
ataxia telangiectasia, common variable immunodeficiency).
7. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments, which may suggest
risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with
uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are
excluded. The following are not exclusionary: vitiligo, childhood asthma that has
resolved, residual hypothyroidism that required only hormone replacement, or
psoriasis that does not require systemic treatment.
8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or
equivalent) within 14 days of randomization. Physiologic replacement doses are
allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are
not being administered for immunosuppressive intent. Patients with clinically
relevant systemic immune suppression within the last 3 months before trial
enrollment are excluded. Inhaled or topical steroids are permitted, provided that
they are not for treatment of an autoimmune disorder.
9. Patients who have received prior systemic therapies are excluded with the exception
of the following:
1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery
and/or radiation therapy) if recurrent or metastatic disease develops more than
6 months after completing therapy as long as toxicities have resolved to CTCAE
grade ≤1 or baseline with the exception of alopecia and peripheral neuropathy.
2. Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as
long as the last dose is >12 months prior to enrollment.
3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or
neoadjuvant 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 time
of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other
non-immunosuppressive therapies without resolution prior to enrollment are
allowed.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Arizona Clinical Research Center
Address:
City:
Tucson
Zip:
85715
Country:
United States
Status:
Recruiting
Contact:
Last name:
Manuel Modiano-Revah, MD
Email:
mmodiano@acrcresearch.com
Facility:
Name:
Yuma Regional Medical Center
Address:
City:
Yuma
Zip:
85364
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abhinav Chandra, MD
Email:
abchandra@yumaregional.org
Facility:
Name:
Desert Hematology Oncology Medical Group, Inc.
Address:
City:
Rancho Mirage
Zip:
92270
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke P Dreisbach, MD
Email:
researchdho@aol.com
Facility:
Name:
Emad Ibrahim, MD, Inc.
Address:
City:
Redlands
Zip:
92373
Country:
United States
Status:
Recruiting
Contact:
Last name:
Emad Ibrahim, MD
Email:
eibrahim@redlandshospital.org
Facility:
Name:
Clermont Oncology Center
Address:
City:
Clermont
Zip:
34711
Country:
United States
Status:
Recruiting
Facility:
Name:
Miami Veterans Administration HealthCare System
Address:
City:
Miami
Zip:
33125
Country:
United States
Status:
Recruiting
Contact:
Last name:
Niramol Savaraj, MD
Email:
nsavaraj@med.miami.edu
Facility:
Name:
Mid Florida Hematology and Oncology Center
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Contact:
Last name:
Santosh M Nair, MD
Email:
drsmnair@aorcorp.com
Facility:
Name:
Pinellas Hematology and Oncology
Address:
City:
Saint Petersburg
Zip:
33709
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neeharika Makani
Email:
nmakani@comphemonc.com
Facility:
Name:
Tallahassee Memorial Healthcare
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Russell, MD
Email:
karen.russell@tmh.org
Facility:
Name:
Mary Bird Perkins Cancer Center
Address:
City:
Baton Rouge
Zip:
70809
Country:
United States
Status:
Recruiting
Contact:
Last name:
Victor Lin, MD
Email:
vlin@marybird.com
Facility:
Name:
Hattiesburg Clinic
Address:
City:
Hattiesburg
Zip:
39401
Country:
United States
Status:
Recruiting
Contact:
Last name:
John Hrom
Email:
bo.hrom@hattiesburgclinic.com
Facility:
Name:
Capital Health Medical Center
Address:
City:
Pennington
Zip:
08534
Country:
United States
Status:
Recruiting
Contact:
Last name:
Arturo Loaiza-Bonilla, MD
Email:
aloaiza-bonilla@capitalhealth.org
Facility:
Name:
New Mexico Cancer Care Alliance/ University of New Mexico
Address:
City:
Albuquerque
Zip:
87131-0001
Country:
United States
Status:
Recruiting
Contact:
Last name:
Atul Kumar, MD
Email:
AtKumar@salud.unm.edu
Facility:
Name:
New York Cancer and Blood Specialists
Address:
City:
Port Jefferson Station
Zip:
11776
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Zuniga, MD
Email:
rzuniga@nycancer.com
Facility:
Name:
Clinical Research Alliance, Inc.
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Contact:
Last name:
James D'Olimpio
Email:
jdolimpio@researchcra.com
Facility:
Name:
Gabrail Cancer Center Research
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabrail Nashat, M.D
Email:
research@gabrailcancercenter.com
Facility:
Name:
Thompson Cancer Survival Center (TCSC ) - Downtown
Address:
City:
Knoxville
Zip:
37916-2300
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Chism
Email:
dchism.research@covhlth.com
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neil Faulkner, MD
Email:
NFaulkner@utmck.edu
Facility:
Name:
University of Virginia Medical Center
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Richard Hall
Email:
rdh3q@virginia.edu
Facility:
Name:
Bon Secours Cancer Institute Richmond
Address:
City:
Midlothian
Zip:
23114
Country:
United States
Status:
Recruiting
Contact:
Last name:
William Irvin
Email:
william_irvin@bshsi.org
Facility:
Name:
Macquarie University Health Science Center (MQ Health)
Address:
City:
Macquarie Park
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
John Park
Email:
john.park@mqhealth.org.au
Facility:
Name:
Riverina Cancer Care Centre (RCCC)
Address:
City:
Wagga Wagga
Zip:
2650
Country:
Australia
Status:
Recruiting
Contact:
Last name:
David Palmieri, MD
Email:
dpalmieri@riverinacancercare.com.au
Facility:
Name:
Southern Medical Day Care Centre
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Facility:
Name:
Ballarat Regional Integrated Cancer Centre (BRICC)
Address:
City:
Ballarat
Zip:
3350
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Wasek Faisal
Email:
wasek.faisal@bhs.org.au
Facility:
Name:
Bendigo Hospital
Address:
City:
Bendigo
Zip:
3550
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Say Ng
Email:
sng@bendigohealth.org.au
Facility:
Name:
British Columbia Cancer Center- Kelowna
Address:
City:
Kelowna
Zip:
V1Y 5L3
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Sara Taylor
Email:
staylor10@bccancer.bc.ca
Facility:
Name:
LTD Cancer Center of Adjara
Address:
City:
Batumi
Zip:
6000
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tamta Makharadze
Email:
tamta.makharadze@gmail.com
Facility:
Name:
Israeli Georgian medical research clinic Helsicore
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Mamia Khutashvilli
Email:
mamology@yahoo.com
Facility:
Name:
The Institute of Clinical Oncology
Address:
City:
Tbilisi
Zip:
0159
Country:
Georgia
Status:
Recruiting
Facility:
Name:
TIM - Tbilisi Institute of Medicine
Address:
City:
Tbilisi
Zip:
0160
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Mariam Zhvania
Email:
m.zhvania@onco.ge
Facility:
Name:
Research Institute of Clinical Medicine
Address:
City:
Tbilisi
Zip:
112
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Tamar Melkadze
Email:
tmelkadze@hotmail.com
Facility:
Name:
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Address:
City:
Tbilisi
Zip:
144
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Miranda Gogishvilli
Email:
mirandagogishvili@yahoo.com
Facility:
Name:
JSC Evex Hospitals- Caraps Medline
Address:
City:
Tbilisi
Zip:
179
Country:
Georgia
Status:
Recruiting
Contact:
Last name:
Nana Chikhladze
Email:
nanuka.chikhladze@yahoo.com
Facility:
Name:
Soroka University Medical Center
Address:
City:
Beer-Sheba
Zip:
84101
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Amichay Meirovitz, MD
Email:
amichaym@gmail.com
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Nir Peled
Email:
NIRP@SZMC.ORG.IL
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
64239
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Sivan Shamai
Email:
sivansh@tlvmc.gov.il
Facility:
Name:
Assuta Medical Centers
Address:
City:
Tel Aviv
Zip:
6971028
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Elizabeth Dudnik
Email:
elizabeth.dudnik1603@gmail.com
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ki Hyeong Lee
Email:
kihlee1963@gmail.com
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyun Woo Lee
Email:
hwlee71@gmail.com
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju
Zip:
54907
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Eun-Kee Song
Email:
eksong@jbnu.ac.kr
Facility:
Name:
Chungnam National University Hospital
Address:
City:
Daejeon
Zip:
35015
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hwan Jung Yun, MD
Email:
hjyun@cnuh.co.kr
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Inha University Hospital
Address:
City:
Incheon
Zip:
22332
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jeong Seon Ryu
Email:
jsryu@inha.ac.kr
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
8308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sung Yong Lee
Email:
syl0801@korea.ac.kr
Facility:
Name:
St. Vincent's Hospital, The Catholic University of Korea
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Byoung Yong Shim, MD
Email:
shimby@catholic.ac.kr
Facility:
Name:
Ulsan University Hospital
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Young-Joo Min
Email:
yjmin65@gmail.com
Facility:
Name:
Hospital Sultan Ismail
Address:
City:
Johor Bahru
Zip:
81100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Chun Sen Lim
Email:
chunsen1@hotmail.com
Facility:
Name:
Hospital Tengku Ampuan Afzan (HTTA)
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
SoonHin How, MD
Email:
how_sh@yahoo.com
Facility:
Name:
National Cancer Institute
Address:
City:
Putrajaya
Zip:
62250
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Suhana Yusak
Email:
suhanayusak@gmail.com
Facility:
Name:
Hospital Kuala Lumpur
Address:
City:
Kuala Lumpur
Zip:
50586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Eznal Mahidin, MD
Email:
eznal.mahidin@gmail.com
Facility:
Name:
Hospital Pulau Pinang
Address:
City:
Pulau Pinang
Zip:
10990
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Ai Lian Tan, MD
Email:
ailian.tan@gmail.com
Facility:
Name:
Hualien Tzu Chi Medical Center
Address:
City:
Hualien City
Zip:
97002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chih-Bin Lin, MD
Email:
ferlin@tzuchi.com.tw
Facility:
Name:
Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jen-Yu Hung, MD
Email:
jenyuhung@gmail.com
Facility:
Name:
Taipei Medical University Shuang Ho Hospital
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Kang-Yun Lee, MD
Email:
13258@s.tmu.edu.tw
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jin-Yuan Shih, MD
Email:
jyshih@ntu.edu.tw
Facility:
Name:
Taipei Medical University Hospital
Address:
City:
Taipei
Zip:
110301
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chao-Hua Chiu, MD
Email:
chaohuachiu@gmail.com
Facility:
Name:
Navamindradhiraj University
Address:
City:
Dusit
Zip:
10300
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Chiang Mai University
Address:
City:
Muang
Zip:
50200
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Lampang Cancer Center
Address:
City:
Lampang
Zip:
52000
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Sirikul Sorrarttichingchai, MD
Facility:
Name:
Istinye University VMMedical Park Pendik Hospital
Address:
City:
Pendik
Zip:
34899
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Necmettin Erbakan University Meram Faculty of Medicine
Address:
City:
Konya
Zip:
42080
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mehmet Artac, MD
Email:
mehmetartac@yahoo.com
Facility:
Name:
Ondokuz Mayis University
Address:
City:
Kurupelit
Zip:
55139
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Bahiddin Yilmaz, MD
Email:
bahiddin.yilmaz@omu.edu.tr
Facility:
Name:
Gulhane Research and Training Hospital
Address:
City:
Ankara
Zip:
06010
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Nuri Karadurmus
Email:
drnkaradurmus@yahoo.com
Facility:
Name:
Gazi University
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Ozan Yazici, MD
Email:
drozanyazici@gmail.com
Facility:
Name:
Sbu Dr.A.Y. Ankara Onkoloji Suam
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Ozturk Ates, MD
Email:
dr.ozturkates@gmail.com
Facility:
Name:
Yuksek Ihtisas Unıversity Medicalpark Hospital
Address:
City:
Ankara
Zip:
06370
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Memorial Ankara Hospital
Address:
City:
Ankara
Zip:
906520
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital
Address:
City:
Istanbul
Zip:
81450
Country:
Turkey
Status:
Recruiting
Start date:
June 30, 2023
Completion date:
February 5, 2032
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05785767
