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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03088540




Registration number
NCT03088540
Ethics application status
Date submitted
3/03/2017
Date registered
23/03/2017
Date last updated
18/06/2024

Titles & IDs
Public title
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Scientific title
A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2016-004407-31
Secondary ID [2] 0 0
R2810-ONC-1624
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma,Non-Small-Cell Lung 0 0
Lung Carcinomas, Non-Small-Cell 0 0
Non-small-cell Lung Carcinoma 0 0
Nonsmall Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - cemiplimab

Active comparator: Standard-of-care chemotherapy - Standard-of-care chemotherapy will administered from these options:

Doses of Paclitaxel + cisplatin OR Doses Paclitaxel + carboplatin OR Doses Gemcitabine + cisplatin or Doses Gemcitabine + carboplatin OR Doses Pemetrexed + cisplatin followed by optional pemetrexed maintenance OR Doses Pemetrexed + carboplatin followed by optional pemetrexed maintenance

Experimental: cemiplimab - cemiplimab regimen as monotherapy as per study protocol


Treatment: Drugs: Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin

Treatment: Drugs: Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin

Treatment: Drugs: Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin

Treatment: Drugs: Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Treatment: Drugs: Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.

Treatment: Drugs: cemiplimab
Patients will be administered cemiplimab as per protocol.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
From date of randomization until the date of death, assessed up to 68 months
Primary outcome [2] 0 0
Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Secondary outcome [1] 0 0
Objective response rates (ORR)
Timepoint [1] 0 0
From date of randomization to the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever comes first, up to 68 months
Secondary outcome [2] 0 0
Best overall response (BOR)
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or the date of subsequent anti-cancer therapy, whichever came first, assessed up to 68 months
Secondary outcome [3] 0 0
Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies
Timepoint [3] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 68 months
Secondary outcome [4] 0 0
Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Timepoint [4] 0 0
Baseline up to 26 months after treatment
Secondary outcome [5] 0 0
Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)
Timepoint [5] 0 0
Baseline up to 26 months after treatment
Secondary outcome [6] 0 0
Incidence of Adverse Events (AEs)
Timepoint [6] 0 0
Baseline up to 68 months after treatment
Secondary outcome [7] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [7] 0 0
Baseline up to 68 months after treatment
Secondary outcome [8] 0 0
Incidence of deaths
Timepoint [8] 0 0
Baseline up to 68 months after treatment
Secondary outcome [9] 0 0
Incidence of laboratory abnormalities
Timepoint [9] 0 0
Baseline up to 68 months after treatment
Secondary outcome [10] 0 0
Measure concentrations of cemiplimab in serum
Timepoint [10] 0 0
Baseline up to 68 months after treatment
Secondary outcome [11] 0 0
Characterize the pharmacokinetics (PK) of cemiplimab
Timepoint [11] 0 0
Baseline up to 68 months after treatment

Eligibility
Key inclusion criteria
Key

A patient must meet the following criteria to be eligible for inclusion in the study:

1. Patients with histologically or cytologically documented squamous or non squamous NSCLC with stage IIIB or stage IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease who received no prior systemic treatment for recurrent or metastatic NSCLC
2. Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrent site, which has not previously been irradiated
3. Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHC performed by the central laboratory
4. At least 1 radiographically measureable lesion per RECIST 1.1
5. ECOG performance status of =1
6. Anticipated life expectancy of at least 3 months
7. Adequate organ and bone marrow function

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient who meets any of the following criteria will be excluded from the study:

1. Patients that 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 EGFR gene mutations, ALK gene translocations, or ROS1 fusions
4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved =6 months prior to randomization
6. Patients with active, known, or suspected autoimmune disease that has required systemic therapy in the past 2 years
7. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
8. Another malignancy that is progressing or requires treatment
9. Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus (HIV) or diagnosis of immunodeficiency
10. Active infection requiring systemic therapy within 14 days prior to randomization
11. Prior therapy with anti-PD 1 or anti-PD L1
12. Treatment-related immune-mediated AEs from immune-modulatory agents
13. Receipt of an investigational drug or device within 30 days
14. Receipt of a live vaccine within 30 days of planned start of study medication
15. Major surgery or significant traumatic injury within 4 weeks prior to first dose
16. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
17. Known psychiatric or substance abuse disorder that would interfere with participation with the requirements of the study, including current use of any illicit drugs
18. Pregnant or breastfeeding women
19. Women of childbearing potential or men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
Accrual to date
Final
712
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Clinical Study Site - Albury
Recruitment hospital [2] 0 0
Clinical Study Site - Wollongong
Recruitment hospital [3] 0 0
Clinical Study Site - Fitzroy
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment outside Australia
Country [1] 0 0
Belarus
State/province [1] 0 0
Minsk
Country [2] 0 0
Belarus
State/province [2] 0 0
Mogilev
Country [3] 0 0
Brazil
State/province [3] 0 0
Rio Grande Do Sul
Country [4] 0 0
Brazil
State/province [4] 0 0
Barretos
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Brazil
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Curitiba
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Brazil
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Joinville
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Brazil
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Lajeado
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Brazil
State/province [8] 0 0
Mogi Das Cruzes
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Brazil
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Passo Fundo
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Brazil
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Pelotas
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Santa Cecília
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Brazil
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Sao Paulo
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Brazil
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São José Do Rio Preto
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Brazil
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São Paulo
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Bulgaria
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Dobrich
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Gabrovo
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Chile
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Recoleta
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Santiago
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Chile
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Temuco
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Chile
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Viña Del Mar
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China
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Shandong
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Harbin
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Linyi
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China
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Shanghai
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China
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Tianjin
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China
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Xuzhou
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China
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Zhejiang
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Nový Jicín
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Czechia
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Pelhrimov
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Czechia
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Prague
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Czechia
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Praha
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Tbilisi
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Bekes
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Bsalîm
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Russian Federation
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Russian Federation
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Russian Federation
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Kislino
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Spain
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Barcelona
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Spain
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Chang Hua
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Hualien City
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Kaohsiung
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New Taipei City
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New Taipei
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Taichung
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Taipei
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Muang
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Bangkok
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Chiang Rai
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Khon Kaen
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Lampang
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Thailand
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Phitsanulok
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Thailand
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Ratchathewi
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Thailand
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Udon Thani
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Samsun
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Ukraine
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Dnepropetrovsk
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Ukraine
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Ivano-Frankivs'k
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Ukraine
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Kharkiv
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Kherson
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Kiev
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Kirovohrad
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Kyiv
Country [143] 0 0
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State/province [143] 0 0
Vinnytsia
Country [144] 0 0
Ukraine
State/province [144] 0 0
Zaporozhye
Country [145] 0 0
Ukraine
State/province [145] 0 0
Úzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of the study are:

* To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in =50% of tumor cells
* To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in =50% of tumor cells

The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies
Trial website
https://clinicaltrials.gov/study/NCT03088540
Trial related presentations / publications
Gumus M, Chen CI, Ivanescu C, Kilickap S, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Harnett J, Mastey V, Naumann U, Reaney M, Konidaris G, Sasane M, Brady KJS, Li S, Gullo G, Rietschel P, Sezer A. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of >/=50%: The EMPOWER-Lung 1 study. Cancer. 2023 Jan 1;129(1):118-129. doi: 10.1002/cncr.34477. Epub 2022 Oct 29. Erratum In: Cancer. 2024 May 1;130(9):1715. doi: 10.1002/cncr.35165.
Sezer A, Kilickap S, Gumus M, Bondarenko I, Ozguroglu M, Gogishvili M, Turk HM, Cicin I, Bentsion D, Gladkov O, Clingan P, Sriuranpong V, Rizvi N, Gao B, Li S, Lee S, McGuire K, Chen CI, Makharadze T, Paydas S, Nechaeva M, Seebach F, Weinreich DM, Yancopoulos GD, Gullo G, Lowy I, Rietschel P. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021 Feb 13;397(10274):592-604. doi: 10.1016/S0140-6736(21)00228-2.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03088540