Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-161132017-001311-36
• Study Type: interventional
• Target: 789
• Locations: 18 countries
• Sites: 133

Brief Summary

The primary objectives of this study are: 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.

Conditions

Non-small Cell Lung Cancer

Keywords

Stage IIIB; Stage IIIC; Stage IV; Non-squamous NSCLC; Squamous NSCLC

Outcome Measures

Primary Outcomes (2)

• Part 1: Overall Survival (OS)

  OS was defined as the time from randomization to the date of death due to any cause.

  Up to a maximum of 82.2 months

• Part 2: OS

  OS was defined as the time from randomization to the date of death due to any cause.

  Up to a maximum of 68.4 months

Secondary Outcomes (19)

• Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)

  Up to a maximum of 82.2 months

• Part 2: PFS Per IRC

  Up to a maximum of 68.4 months

• Part 1: Objective Response Rate (ORR) Per IRC

  Up to 32 months

• Part 2: ORR Per IRC

  Up to 32 months

• Part 1: Duration of Response (DoR)

  Up to 32 months

Study Arms (5)

Chemo

OTHER

Part 1: Chemotherapy

Other: Chemotherapy; Drug: Placebo

REGN2810+Chemo Part 1

EXPERIMENTAL

Part 1: REGN2810+chemo

Drug: REGN2810

REGN2810+AbbrevChemo+ipi

EXPERIMENTAL

Part 1: REGN2810+abbrev chemo+ipi

Drug: REGN2810/chemo/ipi

Placebo+Chemo

EXPERIMENTAL

Part 2: Placebo plus chemo

Drug: Placebo

REGN2810+Chemo Part 2

EXPERIMENTAL

Part 2: REGN2810+chemo

Drug: REGN2810

Interventions

REGN2810 DRUG

REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2

Also known as: cemiplimab

REGN2810+Chemo Part 1; REGN2810+Chemo Part 2

REGN2810/chemo/ipi DRUG

REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1

Also known as: cemiplimab

REGN2810+AbbrevChemo+ipi

Chemotherapy OTHER

Platinum-based doublet chemotherapy Part 1

Chemo

Placebo DRUG

Matching placebo Part 2

Chemo; Placebo+Chemo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥20 years of age for Japanese patients
• 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
• 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
• Part 1 only: Expression of PD-L1 in \<50% of tumor cells determined by a commercially available assay performed by the central laboratory
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Anticipated life expectancy of at least 3 months

You may not qualify if:

• Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
• Active or untreated brain metastases or spinal cord compression
• 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
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
• 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
• 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)
• Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (133)

Regeneron Research Site

Rancho Mirage, California, 92270, United States

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Regeneron Research Site

Riverside, California, 92506, United States

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Whittier, California, 90603, United States

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Orange City, Florida, 32763, United States

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St. Petersburg, Florida, 33709, United States

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Wichita, Kansas, 67214, United States

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Bethesda, Maryland, 20817, United States

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Farmington, New Mexico, 87401, United States

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Gettysburg, Pennsylvania, 17325, United States

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Vienna, 1130, Austria

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Baoding, 071105, China

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Beijing, 100050, China

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Changsha, 410013, China

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Guangzhou, 510080, China

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Hangzhou, 310002, China

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Hangzhou, 310003, China

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Hangzhou, 310009, China

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Hangzhou, 310013, China

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Jinan, 250013, China

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Linyi, 276001, China

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Nanjing, 210003, China

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Shanghai, 200040, China

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Shanghai, 200433, China

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Shenyang, 110042, China

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Xiangyang, 441021, China

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Zhengzhou, 450003, China

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Zhengzhou, 450008, China

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Bayonne, 64100, France

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Créteil, 94010, France

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Le Mans, 72000, France

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Lille, 59037, France

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Lyon, 69310, France

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Mont-de-Marsan, 40024, France

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Saint-Herblain, 44805, France

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Saint-Mandé, 94160, France

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Strasbourg, 67091, France

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Batumi, 6000, Georgia

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Tbilisi, 0112, Georgia

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Tbilisi, 0144, Georgia

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Regeneron Research Site #1

Tbilisi, 0159, Georgia

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Regeneron Research Site #2

Tbilisi, 0159, Georgia

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Tbilisi, 0186, Georgia

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Thessaloniki, Macedonia, 54645, Greece

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Athens, 11527, Greece

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Kifissia, 14564, Greece

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Larissa, 41334, Greece

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Pylaia, 57001, Greece

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Thessaloniki, 54007, Greece

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Dublin, 9, Ireland

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Limerick, V94F858, Ireland

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Cremona, 26100, Italy

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Meldola, 47014, Italy

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Milan, 20162, Italy

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Monserrato, 09042, Italy

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Piacenza, 29121, Italy

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Saronno, 21047, Italy

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Terni, 05100, Italy

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Treviglio, 24047, Italy

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-08660, Lithuania

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Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

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George Town, 10350, Malaysia

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Johor Bahru, 81100, Malaysia

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Kota Kinabalu, 88996, Malaysia

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Kuala Lumpur, 56000, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuantan, 25100, Malaysia

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Pulau Pinang, 10990, Malaysia

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Tanjung Bungah, 11200, Malaysia

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Gdynia, Pomeranian Voivodeship, 81-519, Poland

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Lodz, 90-302, Poland

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Lublin, 20-093, Poland

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Olsztyn, 10-357, Poland

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Otwock, 05-400, Poland

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Poznan, 60-693, Poland

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Rzeszów, 35-021, Poland

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Torun, 87-100, Poland

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Wodzisław Śląski, 44-300, Poland

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Cluj-Napoca, 400006, Romania

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Cluj-Napoca, 400124, Romania

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Craiova, 200094, Romania

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Craiova, 200347, Romania

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Craiova, 200385, Romania

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Ufa, Republic Bashkortost, 450054, Russia

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Arkhangelsk, 163045, Russia

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Belgorod, 308010, Russia

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Chelyabinsk, 454048, Russia

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Kaluga, 248007, Russia

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Kazan', 420029, Russia

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Kursk, 305016, Russia

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Moscow, 115478, Russia

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Moscow, 121467, Russia

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Moscow Region, 143444, Russia

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Omsk, 644013, Russia

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Pushkin, 196603, Russia

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Pyatigorsk, 357502, Russia

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Saint Petersburg, 191104, Russia

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Saint Petersburg, 197758, Russia

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Saint Petersburg, 198255, Russia

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Samara, 443001, Russia

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Saransk, 430032, Russia

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Sochi, 354057, Russia

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Tomsk, 634028, Russia

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Tomsk, 634050, Russia

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Yekaterinburg, 620036, Russia

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Banka, 92101, Slovakia

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Cheongju-si, 28644, South Korea

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Incheon, 21565, South Korea

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Jeonju, 54907, South Korea

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Seongnam-si, 13496, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 05368, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Suwon, 16499, South Korea

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Regeneron Research Site #2

Ratchathewi, Bangkok, 10400, Thailand

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Muang, Changwat Chiang Rai, 57000, Thailand

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A. Mueang, Changwat Lampang, 52000, Thailand

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Muang, Changwat Phitsanulok, 65000, Thailand

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Hat Yai, Changwat Songkhla, 90110, Thailand

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Udon Thani, Udonthani, 41330, Thailand

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Muang, 15000, Thailand

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Regeneron Research Site #1

Ratchathewi, 10400, Thailand

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Adana, 01120, Turkey (Türkiye)

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34000, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Dnipro, 49102, Ukraine

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Kharkiv, 61070, Ukraine

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Kiev, 03022, Ukraine

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Kirovohrad, 25006, Ukraine

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Uzhhorod, 88014, Ukraine

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Vinnytsia, 21029, Ukraine

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Related Publications (4)

• Baramidze A, Makharadze T, Gogishvili M, Melkadze T, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Ag McIntyre D, Perez J, Kaul M, Quek RGW, Seebach F, Rietschel P, Pouliot JF. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 >/= 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial. Lung Cancer. 2024 Jul;193:107821. doi: 10.1016/j.lungcan.2024.107821. Epub 2024 May 13.

  PMID: 38820979 DERIVED

• 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.

  PMID: 37348996 DERIVED

• 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.

  PMID: 37001859 DERIVED

• 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.

  PMID: 36008722 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1: Open label Part 2: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 24, 2018
• Study Start: March 6, 2018
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Locations

AU (1); KR (9); IT (8); RU (22); TH (8); TU (4); US (9); IE (2); LI (2); UA (6); FR (9); GR (6); GE (6); SL (1); MY (9); CN (17); RO (5); PL (9)