Clinical Trials Logo

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
First received
Last updated
Start date May 29, 2017
Est. completion date June 30, 2025

Study information

Verified date June 2024
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
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 June 30, 2025
Est. primary completion date June 30, 2025
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT00985855 - Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer Phase 2
Completed NCT01048645 - Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00098085 - Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04995523 - A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC Phase 1/Phase 2
Completed NCT00910676 - Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors Phase 2
Withdrawn NCT00108186 - Celecoxib Treatment for Lung Cancer Phase 1
Recruiting NCT05037825 - The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Recruiting NCT00379717 - Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00404924 - ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures Phase 3
Completed NCT00102505 - A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Phase 2
Terminated NCT00232206 - Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer Phase 2
Terminated NCT00271323 - Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients Phase 2
Completed NCT00037817 - Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies Phase 1
Completed NCT03444766 - Study of Nivolumab for Advanced Cancers in India Phase 4
Completed NCT04351334 - Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Active, not recruiting NCT02416739 - Anticancer Activity of Nicotinamide on Lung Cancer Phase 2/Phase 3
Completed NCT00444015 - Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC) Phase 1
Completed NCT00162318 - A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Phase 1