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

A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Chemotherapy; Drug: Placebo; Drug: REGN2810; Drug: REGN2810/chemo/ipi

• Study Type: Interventional
• Enrollment (Actual): 789
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1130
    • Regeneron Research Site
• China
  • Baoding, China, 071105
    • Regeneron Research Site
  • Beijing, China, 100050
    • Regeneron Research Site
  • Changsha, China, 410013
    • Regeneron Research Site
  • Guangzhou, China, 510080
    • Regeneron Research Site
  • Hangzhou, China, 310003
    • Regeneron Research Site
  • Hangzhou, China, 310009
    • Regeneron Research Site
  • Hangzhou, China, 310013
    • Regeneron Research Site
  • Hangzhou, China, 310002
    • Regeneron Research Site
  • Jinan, China, 250013
    • Regeneron Research Site
  • Linyi, China, 276001
    • Regeneron Research Site
  • Nanjing, China, 210003
    • Regeneron Research Site
  • Shanghai, China, 200040
    • Regeneron Research Site
  • Shanghai, China, 200433
    • Regeneron Research Site
  • Shenyang, China, 110042
    • Regeneron Research Site
  • Xiangyang, China, 441021
    • Regeneron Research Site
  • Zhengzhou, China, 450008
    • Regeneron Research Site
  • Zhengzhou, China, 450003
    • Regeneron Research Site
• France
  • Bayonne, France, 64100
    • Regeneron Research Site
  • Créteil, France, 94010
    • Regeneron Research Site
  • Le Mans, France, 72000
    • Regeneron Research Site
  • Lille, France, 59037
    • Regeneron Research Site
  • Lyon, France, 69310
    • Regeneron Research Site
  • Mont-de-Marsan, France, 40024
    • Regeneron Research Site
  • Saint-Herblain, France, 44805
    • Regeneron Research Site
  • Saint-Mandé, France, 94160
    • Regeneron Research Site
  • Strasbourg, France, 67091
    • Regeneron Research Site
• Georgia
  • Batumi, Georgia, 6000
    • Regeneron Research Site
  • Tbilisi, Georgia, 0112
    • Regeneron Research Site
  • Tbilisi, Georgia, 0144
    • Regeneron Research Site
  • Tbilisi, Georgia, 0159
    • Regeneron Research Site #1
  • Tbilisi, Georgia, 0159
    • Regeneron Research Site #2
  • Tbilisi, Georgia, 0186
    • Regeneron Research Site
• Greece
  • Athens, Greece, 11527
    • Regeneron Research Site
  • Kifissia, Greece, 14564
    • Regeneron Research Site
  • Larissa, Greece, 41334
    • Regeneron Research Site
  • Pylaia, Greece, 57001
    • Regeneron Research Site
  • Thessaloniki, Greece, 54007
    • Regeneron Research Site
  • Macedonia
    • Thessaloniki, Macedonia, Greece, 54645
      • Regeneron Research Site
• Ireland
  • Dublin, Ireland, 9
    • Regeneron Research Site
  • Limerick, Ireland, V94F858
    • Regeneron Research Site
• Italy
  • Cremona, Italy, 26100
    • Regeneron Research Site
  • Meldola, Italy, 47014
    • Regeneron Research Site
  • Milan, Italy, 20162
    • Regeneron Research Site
  • Monserrato, Italy, 09042
    • Regeneron Research Site
  • Piacenza, Italy, 29121
    • Regeneron Research Site
  • Saronno, Italy, 21047
    • Regeneron Research Site
  • Terni, Italy, 05100
    • Regeneron Research Site
  • Treviglio, Italy, 24047
    • Regeneron Research Site
• Lithuania
  • Klaipėda, Lithuania, LT-92288
    • Regeneron Research Site
  • Vilnius, Lithuania, LT-08660
    • Regeneron Research Site
• Malaysia
  • George Town, Malaysia, 10350
    • Regeneron Research Site
  • Johor Bahru, Malaysia, 81100
    • Regeneron Research Site
  • Kota Kinabalu, Malaysia, 88996
    • Regeneron Research Site
  • Kuala Lumpur, Malaysia, 56000
    • Regeneron Research Site
  • Kuala Lumpur, Malaysia, 59100
    • Regeneron Research Site
  • Kuantan, Malaysia, 25100
    • Regeneron Research Site
  • Pulau Pinang, Malaysia, 10990
    • Regeneron Research Site
  • Tanjung Bungah, Malaysia, 11200
    • Regeneron Research Site
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • Regeneron Research Site
• Poland
  • Lodz, Poland, 90-302
    • Regeneron Research Site
  • Lublin, Poland, 20-093
    • Regeneron Research Site
  • Olsztyn, Poland, 10-357
    • Regeneron Research Site
  • Otwock, Poland, 05-400
    • Regeneron Research Site
  • Poznan, Poland, 60-693
    • Regeneron Research Site
  • Rzeszów, Poland, 35-021
    • Regeneron Research Site
  • Torun, Poland, 87-100
    • Regeneron Research Site
  • Wodzisław Śląski, Poland, 44-300
    • Regeneron Research Site
  • Pomeranian Voivodeship
    • Gdynia, Pomeranian Voivodeship, Poland, 81-519
      • Regeneron Research Site
• Romania
  • Cluj-Napoca, Romania, 400006
    • Regeneron Research Site
  • Cluj-Napoca, Romania, 400124
    • Regeneron Research Site
  • Craiova, Romania, 200094
    • Regeneron Research Site
  • Craiova, Romania, 200347
    • Regeneron Research Site
  • Craiova, Romania, 200385
    • Regeneron Research Site
• Russia
  • Arkhangelsk, Russia, 163045
    • Regeneron Research Site
  • Belgorod, Russia, 308010
    • Regeneron Research Site
  • Chelyabinsk, Russia, 454048
    • Regeneron Research Site
  • Kaluga, Russia, 248007
    • Regeneron Research Site
  • Kazan', Russia, 420029
    • Regeneron Research Site
  • Kursk, Russia, 305016
    • Regeneron Research Site
  • Moscow, Russia, 115478
    • Regeneron Research Site
  • Moscow, Russia, 121467
    • Regeneron Research Site
  • Moscow Region, Russia, 143444
    • Regeneron Research Site
  • Omsk, Russia, 644013
    • Regeneron Research Site
  • Pushkin, Russia, 196603
    • Regeneron Research Site
  • Pyatigorsk, Russia, 357502
    • Regeneron Research Site
  • Saint Petersburg, Russia, 191104
    • Regeneron Research Site
  • Saint Petersburg, Russia, 197758
    • Regeneron Research Site
  • Saint Petersburg, Russia, 198255
    • Regeneron Research Site
  • Samara, Russia, 443001
    • Regeneron Research Site
  • Saransk, Russia, 430032
    • Regeneron Research Site
  • Sochi, Russia, 354057
    • Regeneron Research Site
  • Tomsk, Russia, 634028
    • Regeneron Research Site
  • Tomsk, Russia, 634050
    • Regeneron Research Site
  • Yekaterinburg, Russia, 620036
    • Regeneron Research Site
  • Republic Bashkortost
    • Ufa, Republic Bashkortost, Russia, 450054
      • Regeneron Research Site
• Slovakia
  • Banka, Slovakia, 92101
    • Regeneron Research Site
• South Korea
  • Cheongju-si, South Korea, 28644
    • Regeneron Research Site
  • Incheon, South Korea, 21565
    • Regeneron Research Site
  • Jeonju, South Korea, 54907
    • Regeneron Research Site
  • Seongnam-si, South Korea, 13496
    • Regeneron Research Site
  • Seongnam-si, South Korea, 13620
    • Regeneron Research Site
  • Seoul, South Korea, 05368
    • Regeneron Research Site
  • Seoul, South Korea, 05505
    • Regeneron Research Site
  • Seoul, South Korea, 06351
    • Regeneron Research Site
  • Suwon, South Korea, 16499
    • Regeneron Research Site
• Thailand
  • Muang, Thailand, 15000
    • Regeneron Research Site
  • Ratchathewi, Thailand, 10400
    • Regeneron Research Site #1
  • Bangkok
    • Ratchathewi, Bangkok, Thailand, 10400
      • Regeneron Research Site #2
  • Changwat Chiang Rai
    • Muang, Changwat Chiang Rai, Thailand, 57000
      • Regeneron Research Site
  • Changwat Lampang
    • A. Mueang, Changwat Lampang, Thailand, 52000
      • Regeneron Research Site
  • Changwat Phitsanulok
    • Muang, Changwat Phitsanulok, Thailand, 65000
      • Regeneron Research Site
  • Changwat Songkhla
    • Hat Yai, Changwat Songkhla, Thailand, 90110
      • Regeneron Research Site
  • Udonthani
    • Udon Thani, Udonthani, Thailand, 41330
      • Regeneron Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01120
    • Regeneron Research Site
  • Ankara, Turkey (Türkiye), 06100
    • Regeneron Research Site
  • Istanbul, Turkey (Türkiye), 34000
    • Regeneron Research Site
  • Istanbul, Turkey (Türkiye), 34093
    • Regeneron Research Site
• Ukraine
  • Dnipro, Ukraine, 49102
    • Regeneron Research Site
  • Kharkiv, Ukraine, 61070
    • Regeneron Research Site
  • Kiev, Ukraine, 03022
    • Regeneron Research Site
  • Kirovohrad, Ukraine, 25006
    • Regeneron Research Site
  • Uzhhorod, Ukraine, 88014
    • Regeneron Research Site
  • Vinnytsia, Ukraine, 21029
    • Regeneron Research Site
• United States
  • California
    • Rancho Mirage, California, United States, 92270
      • Regeneron Research Site
    • Riverside, California, United States, 92506
      • Regeneron Research Site
    • Whittier, California, United States, 90603
      • Regeneron Research Site
  • Florida
    • Orange City, Florida, United States, 32763
      • Regeneron Research Site
    • St. Petersburg, Florida, United States, 33709
      • Regeneron Research Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Regeneron Research Site
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Regeneron Research Site
  • New Mexico
    • Farmington, New Mexico, United States, 87401
      • Regeneron Research Site
  • Pennsylvania
    • Gettysburg, Pennsylvania, United States, 17325
      • Regeneron Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Men and women ≥20 years of age for Japanese patients
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

Key Exclusion Criteria:

1. Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Chemo; Part 1: Chemotherapy	Other: Chemotherapy; Platinum-based doublet chemotherapy Part 1; Drug: Placebo; Matching placebo Part 2
Experimental: REGN2810+Chemo Part 1; Part 1: REGN2810+chemo	Drug: REGN2810; REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2; Other Names: cemiplimab
Experimental: REGN2810+AbbrevChemo+ipi; Part 1: REGN2810+abbrev chemo+ipi	Drug: REGN2810/chemo/ipi; REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1; Other Names: cemiplimab
Experimental: Placebo+Chemo; Part 2: Placebo plus chemo	Drug: Placebo; Matching placebo Part 2
Experimental: REGN2810+Chemo Part 2; Part 2: REGN2810+chemo	Drug: REGN2810; REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2; Other Names: cemiplimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)	PFS as assessed by IRC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.	Up to a maximum of 82.2 months
Part 2: PFS Per IRC	PFS as assessed by IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.	Up to a maximum of 68.4 months
Part 1: Objective Response Rate (ORR) Per IRC	ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).	Up to 32 months
Part 2: ORR Per IRC	ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.	Up to 32 months
Part 1: Duration of Response (DoR)	DoR was defined as the time from date of first documented response of CR or PR to the date of first documented progressive disease (PD) or death due to any cause, whichever occurred earlier.	Up to 32 months
Part 2: DoR	DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD or death due to any cause, whichever occurred earlier.	Up to 32 months
Part 1: Best Overall Response (BOR) Per IRC	BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.	Up to 32 months
Part 2: BOR Per IRC	BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.	Up to 32 months
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.	From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With TEAEs	TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.	From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	Part 1 only	28 days
Part 1: Number of Participants With Serious TEAEs	Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.	From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With Serious TEAEs	Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.	From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Deaths During the On-Treatment Period	The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.	Up to 28 months
Part 2: Number of Deaths During the On-Treatment Period	The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.	Up to 28 months
Part 1: Estimated Survival Probability	OS rate at a landmark (12, 18, and 24 months) was defined as the Kaplan-Meier (K-M) estimated probability of participants who survived due to any cause at the landmark after randomization.	12 months, 18 months, 24 months
Part 2: Estimated Survival Probability	OS rate at a landmark (12, 18, and 24 months) was defined as the K-M estimated probability of participants who survived due to any cause at the landmark after randomization.	12 months, 18 months, 24 months
Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.	Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30	The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.	Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36; Follow-up 1 (14 to 30 days after last study treatment)

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• A Plain Language Summary is available on TrialSummaries.com

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Squamous NSCLC; Stage IV; Stage IIIB; Stage IIIC; Non-squamous NSCLC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Therapeutics; Drug Therapy; cemiplimab
• Other Study ID Numbers: R2810-ONC-16113; 2017-001311-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No