Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
NCT ID: NCT03409614
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
790 participants
INTERVENTIONAL
2018-03-06
2025-02-27
Brief Summary
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Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells.
Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
The key secondary objectives are:
Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells.
Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Chemo
Part 1: Chemotherapy
Chemotherapy
Platinum-based doublet chemotherapy Part 1
Placebo
Matching placebo Part 2
REGN2810+Chemo Part 1
Part 1: REGN2810+chemo
REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810+AbbrevChemo+ipi
Part 1: REGN2810+abbrev chemo+ipi
REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Placebo+Chemo
Part 2: Placebo plus chemo
Placebo
Matching placebo Part 2
REGN2810+Chemo Part 2
Part 2: REGN2810+chemo
REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
Interventions
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REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Chemotherapy
Platinum-based doublet chemotherapy Part 1
Placebo
Matching placebo Part 2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
4. Part 1 only: Expression of PD-L1 in \<50% of tumor cells determined by a commercially available assay performed by the central laboratory
5. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
7. Anticipated life expectancy of at least 3 months
Exclusion Criteria
2. Active or untreated brain metastases or spinal cord compression
3. Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
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
6. Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
7. Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron Research Site
Rancho Mirage, California, United States
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Riverside, California, United States
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Whittier, California, United States
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Orange City, Florida, United States
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St. Petersburg, Florida, United States
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Wichita, Kansas, United States
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Bethesda, Maryland, United States
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Farmington, New Mexico, United States
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Gettysburg, Pennsylvania, United States
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Vienna, , Austria
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Baoding, , China
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Beijing, , China
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Changsha, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Linyi, , China
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Nanjing, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Xiangyang, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Bayonne, , France
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Créteil, , France
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Le Mans, , France
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Lille, , France
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Lyon, , France
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Mont-de-Marsan, , France
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Saint-Herblain, , France
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Saint-Mandé, , France
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Strasbourg, , France
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Batumi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Thessaloniki, Macedonia, Greece
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Athens, , Greece
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Kifissia, , Greece
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Larissa, , Greece
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Pylaia, , Greece
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Thessaloniki, , Greece
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Dublin, , Ireland
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Limerick, , Ireland
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Cremona, , Italy
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Meldola, , Italy
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Milan, , Italy
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Monserrato, , Italy
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Piacenza, , Italy
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Saronno, , Italy
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Terni, , Italy
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Treviglio, , Italy
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Kuala Lumpur, Kuala Lumpur, Malaysia
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Pulau Pinang, , Malaysia
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Tanjung Bungah, , Malaysia
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Gdynia, Pomeranian Voivodeship, Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Torun, , Poland
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Wodzisław Śląski, , Poland
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Craiova, , Romania
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Ufa, Republic Bashkortost, Russia
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Arkhangelsk, , Russia
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Belgorod, , Russia
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Chelyabinsk, , Russia
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Kaluga, , Russia
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Kazan', , Russia
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Kursk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow Region, , Russia
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Omsk, , Russia
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Pushkin, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saransk, , Russia
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Sochi, , Russia
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Tomsk, , Russia
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Tomsk, , Russia
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Yekaterinburg, , Russia
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Banka, , Slovakia
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Cheongju-si, , South Korea
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Incheon, , South Korea
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Jeonju, , South Korea
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Seongnam-si, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Ratchathewi, Bangkok, Thailand
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Muang, Changwat Chiang Rai, Thailand
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A. Mueang, Changwat Lampang, Thailand
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Muang, Changwat Phitsanulok, Thailand
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Hat Yai, Changwat Songkhla, Thailand
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Udon Thani, Udonthani, Thailand
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Muang, , Thailand
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Ratchathewi, , Thailand
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Dnipro, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kirovohrad, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
Countries
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References
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Zhao B, Qi H, Wu J, Ma W. Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jul;18(7):e72-e73. doi: 10.1016/j.jtho.2023.04.001. No abstract available.
Makharadze T, Gogishvili M, Melkadze T, Baramidze A, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Li S, Li Y, Kaul M, Quek RGW, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jun;18(6):755-768. doi: 10.1016/j.jtho.2023.03.008. Epub 2023 Mar 29.
Gogishvili M, Melkadze T, Makharadze T, Giorgadze D, Dvorkin M, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Gessner C, Moreno-Jaime B, Passalacqua R, Li S, McGuire K, Kaul M, Paccaly A, Quek RGW, Gao B, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Gullo G, Rietschel P. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25.
Other Identifiers
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2017-001311-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R2810-ONC-16113
Identifier Type: -
Identifier Source: org_study_id
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