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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03409614
• Other study ID #: R2810-ONC-16113
• Secondary ID: 2017-001311-36
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 6, 2018
• Est. completion date: February 3, 2025

Study information

• Verified date: April 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 790
• Est. completion date: February 3, 2025
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
• REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1

Other:
• Chemotherapy
Platinum-based doublet chemotherapy Part 1

Drug:
• Placebo
Matching placebo Part 2

Locations

Country	Name	City	State
Austria	Regeneron Research Site	Wien
China	Regeneron Research Site	Baoding
China	Regeneron research Site	Beijing
China	Regeneron Research Site	Changsha
China	Regeneron Research Site	Guangzhou
China	Regeneron Research Site	Hangzhou
China	Regeneron Research Site	Hangzhou
China	Regeneron Research Site	Hangzhou
China	Regeneron Research Site	Hangzhou Shi
China	Regeneron Research Site	Jinan
China	Regeneron Research Site	Linyi City
China	Regeneron Research Site	Nanjing Shi
China	Regeneron Research Site	Shanghai
China	Regeneron Research Site	Shanghai
China	Regeneron Research Site	Shenyang
China	Regeneron Research Site	Xiangyang Shi
China	Regeneron Research Site	Zhengzhou
China	Regeneron Research Site	Zhengzhou City
France	Regeneron Research Site	Bayonne
France	Regeneron Research Site	Creteil
France	Regeneron Research Site	Le Mans
France	Regeneron Research Site	Lille
France	Regeneron Research Site	Lyon
France	Regeneron Research Site	Mont-de-Marsan
France	Regeneron Research Site	Saint Herblain Cedex
France	Regeneron Research Site	Saint-Mandé
France	Regeneron Research Site	Strasbourg
Georgia	Regeneron Research Site	Batumi
Georgia	Regeneron Research Site	Tbilisi
Georgia	Regeneron Research Site	Tbilisi
Georgia	Regeneron Research Site	Tbilisi
Georgia	Regeneron Research Site #1	Tbilisi
Georgia	Regeneron Research Site #2	Tbilisi
Greece	Regeneron Research Site	Athens
Greece	Regeneron Research Site	Kifisia
Greece	Regeneron Research Site	Larissa
Greece	Regeneron Research Site	Pylaia
Greece	Regeneron Research Site	Thessaloniki
Greece	Regeneron Research Site	Thessaloniki	Macedonia
Ireland	Regeneron Research Site	Dublin
Ireland	Regeneron Research Site	Limerick
Italy	Regeneron Research Site	Cremona
Italy	Regeneron Research Site	Meldola
Italy	Regeneron Research Site	Milano
Italy	Regeneron Research Site	Monserrato
Italy	Regeneron Research Site	Piacenza
Italy	Regeneron Research Site	Saronno
Italy	Regeneron Research Site	Terni
Italy	Regeneron Research Site	Treviglio
Korea, Republic of	Regeneron Research Site	Cheongju-si
Korea, Republic of	Regeneron Research Site	Incheon
Korea, Republic of	Regeneron Research Site	Jeonju
Korea, Republic of	Regeneron Research Site	Seongnam-si
Korea, Republic of	Regeneron Research Site	Seongnam-si
Korea, Republic of	Regeneron Research Site	Seoul
Korea, Republic of	Regeneron Research Site	Seoul
Korea, Republic of	Regeneron Research Site	Seoul
Korea, Republic of	Regeneron Research Site	Suwon-si
Lithuania	Regeneron Research Site	Klaipeda
Lithuania	Regeneron Research Site	Vilnius
Malaysia	Regeneron Research Site	Johor Bahru
Malaysia	Regeneron Research Site	Kota Kinabalu
Malaysia	Regeneron Research Site	Kuala Lumpur
Malaysia	Regeneron Research Site	Kuala Lumpur
Malaysia	Regeneron Research Site	Kuala Lumpur	Wilayah Persekutuan
Malaysia	Regeneron Research Site	Kuantan
Malaysia	Regeneron Research Site	Penang
Malaysia	Regeneron Research Site	Pulau Pinang
Malaysia	Regeneron Research Site	Tanjung Bungah
Poland	Regeneron Research Site	Gdynia	Pomorskie
Poland	Regeneron Research Site	Lódz
Poland	Regeneron Research Site	Lublin
Poland	Regeneron Research Site	Olsztyn
Poland	Regeneron Research Site	Otwock
Poland	Regeneron Research Site	Poznan
Poland	Regeneron Research Site	Rzeszow
Poland	Regeneron Research Site	Torun
Poland	Regeneron Research Site	Wodzislaw Slaski
Romania	Regeneron Research Site	Cluj Napoca
Romania	Regeneron Research Site	Cluj Napoca
Romania	Regeneron Research Site	Craiova
Romania	Regeneron Research Site	Craiova
Romania	Regeneron Research Site	Craiova
Russian Federation	Regeneron Research Site	Arkhangel'sk
Russian Federation	Regeneron Research Site	Belgorod
Russian Federation	Regeneron Research Site	Chelyabinsk
Russian Federation	Regeneron Research Site	Ekaterinburg
Russian Federation	Regeneron Research Site	Kaluga
Russian Federation	Regeneron Research Site	Kazan
Russian Federation	Regeneron Research Site	Kursk
Russian Federation	Regeneron Research Site	Moscow
Russian Federation	Regeneron Research Site	Moscow
Russian Federation	Regeneron Research Site	Moscow region
Russian Federation	Regeneron Research Site	Omsk
Russian Federation	Regeneron Research Site	Pushkin
Russian Federation	Regeneron Research Site	Pyatigorsk
Russian Federation	Regeneron Research Site	Saint Petersburg
Russian Federation	Regeneron Research Site	Saint Petersburg
Russian Federation	Regeneron Research Site	Saint Petersburg
Russian Federation	Regeneron Research Site	Samara
Russian Federation	Regeneron Research Site	Saransk
Russian Federation	Regeneron Research Site	Sochi
Russian Federation	Regeneron Research Site	Tomsk
Russian Federation	Regeneron Research Site	Tomsk
Russian Federation	Regeneron Research Site	Ufa	Republic Bashkortost
Slovakia	Regeneron Research Site	Banka
Thailand	Regeneron Research Site	A. Mueang	Lampang
Thailand	Regeneron Research Site	Hat Yai	Songkhla
Thailand	Regeneron Research Site	Muang
Thailand	Regeneron Research Site	Muang	Phitsanulok
Thailand	Regeneron Research Site	Muang	Chiang Rai
Thailand	Regeneron Research Site #1	Ratchathewi
Thailand	Regeneron Research Site #2	Ratchathewi	Bangkok
Thailand	Regeneron Research Site	Udonthani
Turkey	Regeneron Research Site	Adana
Turkey	Regeneron Research Site	Ankara
Turkey	Regeneron Research Site	Istanbul
Turkey	Regeneron Research Site	Istanbul
Ukraine	Regeneron Research Site	Dnipro
Ukraine	Regeneron Research Site	Kharkiv
Ukraine	Regeneron Research Site	Kiev
Ukraine	Regeneron Research Site	Kirovohrad
Ukraine	Regeneron Research Site	Uzhgorod
Ukraine	Regeneron Research Site	Vinnytsia
United States	Regeneron Research Site	Bethesda	Maryland
United States	Regeneron Research Site	Farmington	New Mexico
United States	Regeneron Research Site	Gettysburg	Pennsylvania
United States	Regeneron Research Site	Orange City	Florida
United States	Regeneron Research Site	Rancho Mirage	California
United States	Regeneron Research Site	Riverside	California
United States	Regeneron Research Site	Saint Petersburg	Florida
United States	Regeneron Research Site	Whittier	California
United States	Regeneron Research Site	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Austria,  China,  France,  Georgia,  Greece,  Ireland,  Italy,  Korea, Republic of,  Lithuania,  Malaysia,  Poland,  Romania,  Russian Federation,  Slovakia,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 32 months
Secondary	Progression-free survival		Up to 32 months
Secondary	Objective response rate		Up to 32 months
Secondary	Duration of Response (DOR)		Up to 32 months
Secondary	Best overall response (BOR)		Up to 32 months
Secondary	Incidence of Treatment-emergent adverse events (TEAEs)		Up to 32 months
Secondary	Incidence of Dose-limiting toxicities (DLTs)	Part 1 only	Up to 32 months
Secondary	Incidence of serious adverse events (SAEs)		Up to 32 months
Secondary	Incidence of deaths		Up to 32 months
Secondary	Incidence of laboratory abnormalities		Up to 32 months
Secondary	Overall survival rate		12 months
Secondary	Overall survival rate		18 months
Secondary	Overall survival rate		24 months
Secondary	Quality of life as measured by EORTC QLQ-C30	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	Up to 32 months
Secondary	Quality of life as measured by EORTC QLQ-LC13	Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)	Up to 32 months