Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Non-small-cell Lung Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03088540
• Other study ID #: R2810-ONC-1624
• Secondary ID: 2016-004407-31
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 29, 2017
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

There is option to join genomics sub-study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 712
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma,Non-Small-Cell Lung
• Lung Carcinomas, Non-Small-Cell
• Lung Neoplasms
• Non-small-cell Lung Carcinoma
• Nonsmall Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
• Paclitaxel
Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
• Gemcitabine
Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
• Cisplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
• Carboplatin
Administered with either Pemetrexed, Paclitaxel or gemcitabine.
• cemiplimab
Patients will be administered cemiplimab as per protocol.

Locations

Country	Name	City	State
Australia	Clinical Study Site	Albury	New South Wales
Australia	Clinical Study Site	Fitzroy
Australia	Clinical Study Site	Wollongong	New South Wales
Belarus	Clinical Study Site	Minsk
Belarus	Clinical Study Site	Mogilev
Brazil	Clinical Study Site	Barretos
Brazil	Clinical Study Site	Curitiba
Brazil	Clinical Study Site	Joinville
Brazil	Clinical Study Site	Lajeado
Brazil	Clinical Study Site	Mogi Das Cruzes
Brazil	Clinical Study Site	Passo Fundo
Brazil	Clinical Study Site	Pelotas
Brazil	Clinical Study Site 1	Porto Alegre	Rio Grande Do Sul
Brazil	Clinical Study Site 2	Porto Alegre
Brazil	Clinical Study Site 3	Porto Alegre
Brazil	Clinical Study Site	Recife
Brazil	Clinical Study Site	Rio De Janeiro
Brazil	Clinical Study Site	Salvador
Brazil	Clinical Study Site	Santa Cecília
Brazil	Clinical Study Site	São José Do Rio Preto
Brazil	Clinical Study Site #4	Sao Paulo
Brazil	Clinical Study Site #3	São Paulo
Brazil	Clinical Study Site 1	São Paulo
Brazil	Clinical Study Site 2	São Paulo
Bulgaria	Clinical Study Site	Dobrich
Bulgaria	Clinical Study Site	Gabrovo
Chile	Clinical Study Site	Recoleta
Chile	Clinical Study Site	Santiago
Chile	Clinical Study Site	Temuco
Chile	Clincial Study Site	Viña Del Mar
China	Clinical Study Site	Guangdong
China	Clinical Study Site	Harbin
China	Clinical Study Site	Lanshan	Shandong
China	Clinical Study Site	Linyi
China	Clinical Study Site 1	Shanghai
China	Clinical Study Site 2	Shanghai
China	Clinical Study Site 1	Tianjin
China	Clinical Study Site 2	Tianjin
China	Clinical Study Site	Xuzhou
China	Clinical Study Site	Zhejiang
Colombia	Clinical Study Site	Barranquilla
Colombia	Clinical Study Site	Bogotá
Colombia	Clinical Study Site	Floridablanca
Czechia	Clinical Study Site	Nový Jicín
Czechia	Clinical Study Site	Pelhrimov
Czechia	Clinical Study Site	Prague
Czechia	Clinical Study Site	Praha
Georgia	Clinical Study Site	Batumi
Georgia	Clinical Study Site #6	Tbilisi
Georgia	Clinical Study Site 1	Tbilisi
Georgia	Clinical Study Site 2	Tbilisi
Georgia	Clinical Study Site 3	Tbilisi
Georgia	Clinical Study Site 4	Tbilisi
Georgia	Clinical Study Site 5	Tbilisi
Greece	Clinical Study Site 1	Athens
Greece	Clinical Study Site 2	Athens
Greece	Clinical Study Site 3	Athens
Greece	Clinical Study Site	Cholargós	Attiki
Greece	Clinical Study Site	Larissa
Greece	Clinical Study Site	Patras	Achaia
Greece	Clinical Study Site	Pylaía
Greece	Clinical Study Site 1	Thessaloníki
Greece	Clinical Study Site 2	Thessaloníki
Greece	Clinical Study Site 3	Thessaloníki
Hungary	Clinical Study Site	Budapest
Hungary	Clinical Study Site	Debrecen
Hungary	Clinical Study Site	Farkasgyepu	Veszprém
Hungary	Clinical Study Site	Gyula	Bekes
Hungary	Clinical Study Site	Tatabánya	Komarom-Esztergom
Hungary	Clinical Study Site	Zalaegerszeg
Jordan	Clinical Study Site	Amman
Jordan	Clinical Study Site	Irbid
Lebanon	Clinical Study Site	Bsalîm
Lebanon	Clinical Study Site	Mazraat Ech Choûf
Lebanon	Clinical Study Site	Sidon
Malaysia	Clinical Study Site	Kampung Baharu Nilai
Malaysia	Clinical Study Site #1	Kuala Lumpur
Malaysia	Clinical Study Site #2	Kuala Lumpur
Malaysia	Clinical Study Site	Kuching
Malaysia	Clinical Study Site	Pulau Pinang
Malaysia	Clinical Study Site	Tanjong Bungah
Mexico	Clinical Study Site	Coahuila
Mexico	Clinical Study Site	Cuautitlán
Mexico	Clinical Study Site	Jalisco
Mexico	Clinical Study Site	León de los Aldama
Mexico	Clinical Study Site 1	Monterrey
Mexico	Clinical Study Site 2	Monterrey
Mexico	Clinical Study Site 3	Monterrey
Mexico	Clinical Study Site	Oaxaca
Mexico	Clinical Study Site	San Luis Potosí
Philippines	Clinical Study Site	Bacolod City
Philippines	Clinical Study Site	Batangas
Philippines	Clinical Study Site	Cebu
Philippines	Clinical Study Site	Davao City
Philippines	Clinical Study Site 1	Manila
Philippines	Clinical Study Site 2	Manila
Philippines	Clinical Study Site #1	Quezon City
Philippines	Clinical Study Site #2	Quezon City
Philippines	Clinical Study Site	Taguig
Poland	Clinical Study Site	Dabrowa Górnicza
Poland	Clinical Study Site	Gdynia
Poland	Clinical Study Site	Kraków
Poland	Clinical Study Site	Lódz
Poland	Clinical Study Site	Olsztyn
Poland	Clinical Study Site	Poznan
Poland	Clinical Study Site	Prabuty
Poland	Clinical Study Site	Radom
Poland	Clinical Study Site	Rzeszów
Poland	Clinical Study Site	Torun
Poland	Clinical Study Site	Warszawa
Poland	Clinical Study Site	Wodzislaw Slaski
Romania	Clinical Study Site 1	Craiova
Romania	Clinical Study Site 2	Craiova
Romania	Clinical Study Site	Floresti
Romania	Clinical Study Site	Ploiesti
Romania	Clinical Study Site	Timisoara
Russian Federation	Clinical Study Site	Arkhangel'sk
Russian Federation	Clinical Study Site	Belgorod
Russian Federation	Clinical Study Site	Chelyabinsk
Russian Federation	Clinical Study Site	Kaluga
Russian Federation	Clinical Study Site	Kazan
Russian Federation	Clinical Study Site	Kemerovo
Russian Federation	Clinical Study Site	Kislino
Russian Federation	Clinical Study Site	Kursk
Russian Federation	Clinical Study Site 1	Moscow
Russian Federation	Clinical Study Site 2	Moscow
Russian Federation	Clinical Study Site 3	Moscow
Russian Federation	Clinical Study Site	Omsk
Russian Federation	Clinical Study Site	Pushkin	Saint Petersburg
Russian Federation	Clinical Study Site	Pyatigorsk
Russian Federation	Clinical Study Site 1	Saint Petersburg
Russian Federation	Clinical Study Site 2	Saint Petersburg
Russian Federation	Clinical Study Site 3	Saint Petersburg
Russian Federation	Clinical Study Site 4	Saint Petersburg
Russian Federation	Clinical Study Site	Samara
Russian Federation	Clinical Study Site	Saransk
Russian Federation	Clinical Study Site	Sochi
Russian Federation	Clinical Study Site 1	Tomsk
Russian Federation	Clinical Study Site 2	Tomsk
Russian Federation	Clinical Study Site	Ufa	Republic Bashkortost
Russian Federation	Clinical Study Site	Yekaterinburg
Spain	Clinical Study Site	Barcelona
Spain	Clinical Study Site	Manresa	Barcelona
Spain	Clinical Study Site	Pamplona
Taiwan	Clinical Study Site	Chang Hua
Taiwan	Clinical Study Site	Hualien City
Taiwan	Clinical Study Site 1	Kaohsiung
Taiwan	Clinical Study Site 2	Kaohsiung
Taiwan	Clinical Study Site 2	New Taipei
Taiwan	Clinical Study Site 1	New Taipei City
Taiwan	Clinical Study Site 1	Taichung
Taiwan	Clinical Study Site 2	Taichung
Taiwan	Clinical Study Site 1	Taipei
Taiwan	Clinical Study Site 2	Taipei
Taiwan	Clinical Study Site 3	Taipei
Thailand	Clinical Study Site #1	Bangkok
Thailand	Clinical Study Site #2	Bangkok
Thailand	Clinical Study Site	Chiang Rai
Thailand	Clinical Study Site	Hat Yai	Songkhla
Thailand	Clinical Study Site	Khon Kaen
Thailand	Clinical Study Site	Lampang
Thailand	Clinical Study Site	Lop Buri	Muang
Thailand	Clinical Study Site	Phitsanulok
Thailand	Clinical Study Site	Ratchathewi
Thailand	Clinical Study Site	Udon Thani
Turkey	Clinical Study Site 1	Adana
Turkey	Clinical Study Site 2	Adana
Turkey	Clinical Study Site 1	Ankara
Turkey	Clinical Study Site 2	Ankara
Turkey	Clinical Study Site 3	Ankara
Turkey	Clinical Study Site 4	Ankara
Turkey	Clinical Study Site 5	Ankara
Turkey	Clinical Study Site	Edirne
Turkey	Clinical Study Site 1	Istanbul
Turkey	Clinical Study Site 2	Istanbul
Turkey	Clinical Study Site 3	Istanbul
Turkey	Clinical Study Site 4	Istanbul
Turkey	Clinical Study Site 1	Izmir
Turkey	Clinical Study Site 2	Izmir
Turkey	Clinical Study Site 3	Izmir
Turkey	Clinical Study Site	Samsun
Ukraine	Clinical Study Site	Dnepropetrovsk
Ukraine	Clinical Study Site	Ivano-Frankivs'k
Ukraine	Clinical Study Site	Kharkiv
Ukraine	Clinical Study Site	Kherson
Ukraine	Clinical Study Site 1	Kiev
Ukraine	Clinical Study Site 2	Kiev
Ukraine	Clinical Study Site	Kirovohrad
Ukraine	Clinical Study Site 1	Kyiv
Ukraine	Clinical Study Site 2	Kyiv
Ukraine	Clinical Study Site	Úzhgorod
Ukraine	Clinical Study Site	Vinnytsia
Ukraine	Clinical Study Site	Zaporozhye

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

Australia,  Belarus,  Brazil,  Bulgaria,  Chile,  China,  Colombia,  Czechia,  Georgia,  Greece,  Hungary,  Jordan,  Lebanon,  Malaysia,  Mexico,  Philippines,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		From date of randomization until the date of death, assessed up to 68 months
Primary	Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1	PFS as assessed by a blinded IRC using RECIST 1.1.	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	Objective response rates (ORR)	The number of patients with a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of patients in the efficacy analysis set	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	Best overall response (BOR)	The BOR, as determined by the IRC per RECIST 1.1	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	Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies	Duration of response will be defined as the time between the date of first response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy or death due to any cause, whichever comes first	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	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)		Baseline up to 26 months after treatment
Secondary	Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13)		Baseline up to 26 months after treatment
Secondary	Incidence of Adverse Events (AEs)		Baseline up to 68 months after treatment
Secondary	Incidence of serious adverse events (SAEs)		Baseline up to 68 months after treatment
Secondary	Incidence of deaths		Baseline up to 68 months after treatment
Secondary	Incidence of laboratory abnormalities	Number of patients with laboratory abnormalities	Baseline up to 68 months after treatment
Secondary	Measure concentrations of cemiplimab in serum	Maximum Plasma Concentration [Cmax]	Baseline up to 68 months after treatment
Secondary	Characterize the pharmacokinetics (PK) of cemiplimab	Area Under the Curve [AUC]	Baseline up to 68 months after treatment