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

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03088540
• Collaborator: Sanofi (Industry)
• Enrollment: 712
• Locations: 193
• Arms: 2
• Anticipated Duration (Months): 65.1
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma，Non-Small-Cell Lung; Lung Carcinomas, Non-Small-Cell; Non-small-cell Lung Carcinoma; Nonsmall Cell Lung Cancer	Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Cisplatin; Drug: Carboplatin; Drug: cemiplimab	Phase 3

Detailed Description

There is option to join genomics sub-study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 712 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 29, 2017
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Pemetrexed; Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin; Drug: Paclitaxel; Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin; Drug: Gemcitabine; Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin; Drug: Cisplatin; Administered with either Pemetrexed, Paclitaxel or gemcitabine.; Drug: Carboplatin; Administered with either Pemetrexed, Paclitaxel or gemcitabine.
Experimental: cemiplimab cemiplimab regimen as monotherapy as per study protocol	Drug: cemiplimab; Patients will be administered cemiplimab as per protocol.; Other Names: REGN2810 Libtayo

Outcome Measures

Primary Outcome Measures

1. Overall survival (OS) [From date of randomization until the date of death, assessed up to 68 months]

2. Progression-free survival (PFS) as assessed by a blinded Independent review committee (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]

   PFS as assessed by a blinded IRC using RECIST 1.1.

Secondary Outcome Measures

1. Objective response rates (ORR) [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]

   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

2. Best overall response (BOR) [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]

   The BOR, as determined by the IRC per RECIST 1.1

3. Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies [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]

   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

4. 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]

5. 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]

6. Incidence of Adverse Events (AEs) [Baseline up to 68 months after treatment]

7. Incidence of serious adverse events (SAEs) [Baseline up to 68 months after treatment]

8. Incidence of deaths [Baseline up to 68 months after treatment]

9. Incidence of laboratory abnormalities [Baseline up to 68 months after treatment]

   Number of patients with laboratory abnormalities

10. Measure concentrations of cemiplimab in serum [Baseline up to 68 months after treatment]

    Maximum Plasma Concentration [Cmax]

11. Characterize the pharmacokinetics (PK) of cemiplimab [Baseline up to 68 months after treatment]

    Area Under the Curve [AUC]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Study Site	Albury	New South Wales	Australia
2	Clinical Study Site	Wollongong	New South Wales	Australia
3	Clinical Study Site	Fitzroy		Australia
4	Clinical Study Site	Minsk		Belarus
5	Clinical Study Site	Mogilev		Belarus
6	Clinical Study Site 1	Porto Alegre	Rio Grande Do Sul	Brazil
7	Clinical Study Site	Barretos		Brazil
8	Clinical Study Site	Curitiba		Brazil
9	Clinical Study Site	Joinville		Brazil
10	Clinical Study Site	Lajeado		Brazil
11	Clinical Study Site	Mogi Das Cruzes		Brazil
12	Clinical Study Site	Passo Fundo		Brazil
13	Clinical Study Site	Pelotas		Brazil
14	Clinical Study Site 2	Porto Alegre		Brazil
15	Clinical Study Site 3	Porto Alegre		Brazil
16	Clinical Study Site	Recife		Brazil
17	Clinical Study Site	Rio De Janeiro		Brazil
18	Clinical Study Site	Salvador		Brazil
19	Clinical Study Site	Santa Cecília		Brazil
20	Clinical Study Site #4	Sao Paulo		Brazil
21	Clinical Study Site	São José Do Rio Preto		Brazil
22	Clinical Study Site #3	São Paulo		Brazil
23	Clinical Study Site 1	São Paulo		Brazil
24	Clinical Study Site 2	São Paulo		Brazil
25	Clinical Study Site	Dobrich		Bulgaria
26	Clinical Study Site	Gabrovo		Bulgaria
27	Clinical Study Site	Recoleta		Chile
28	Clinical Study Site	Santiago		Chile
29	Clinical Study Site	Temuco		Chile
30	Clincial Study Site	Viña Del Mar		Chile
31	Clinical Study Site	Lanshan	Shandong	China
32	Clinical Study Site	Guangdong		China
33	Clinical Study Site	Harbin		China
34	Clinical Study Site	Linyi		China
35	Clinical Study Site 1	Shanghai		China
36	Clinical Study Site 2	Shanghai		China
37	Clinical Study Site 1	Tianjin		China
38	Clinical Study Site 2	Tianjin		China
39	Clinical Study Site	Xuzhou		China
40	Clinical Study Site	Zhejiang		China
41	Clinical Study Site	Barranquilla		Colombia
42	Clinical Study Site	Bogotá		Colombia
43	Clinical Study Site	Floridablanca		Colombia
44	Clinical Study Site	Nový Jičín		Czechia
45	Clinical Study Site	Pelhřimov		Czechia
46	Clinical Study Site	Prague		Czechia
47	Clinical Study Site	Praha		Czechia
48	Clinical Study Site	Batumi		Georgia
49	Clinical Study Site #6	Tbilisi		Georgia
50	Clinical Study Site 1	Tbilisi		Georgia
51	Clinical Study Site 2	Tbilisi		Georgia
52	Clinical Study Site 3	Tbilisi		Georgia
53	Clinical Study Site 4	Tbilisi		Georgia
54	Clinical Study Site 5	Tbilisi		Georgia
55	Clinical Study Site	Patras	Achaia	Greece
56	Clinical Study Site	Cholargós	Attiki	Greece
57	Clinical Study Site 1	Athens		Greece
58	Clinical Study Site 2	Athens		Greece
59	Clinical Study Site 3	Athens		Greece
60	Clinical Study Site	Larissa		Greece
61	Clinical Study Site	Pylaía		Greece
62	Clinical Study Site 1	Thessaloníki		Greece
63	Clinical Study Site 2	Thessaloníki		Greece
64	Clinical Study Site 3	Thessaloníki		Greece
65	Clinical Study Site	Gyula	Bekes	Hungary
66	Clinical Study Site	Tatabánya	Komarom-Esztergom	Hungary
67	Clinical Study Site	Farkasgyepű	Veszprém	Hungary
68	Clinical Study Site	Budapest		Hungary
69	Clinical Study Site	Debrecen		Hungary
70	Clinical Study Site	Zalaegerszeg		Hungary
71	Clinical Study Site	Amman		Jordan
72	Clinical Study Site	Irbid		Jordan
73	Clinical Study Site	Bsalîm		Lebanon
74	Clinical Study Site	Mazraat Ech Choûf		Lebanon
75	Clinical Study Site	Sidon		Lebanon
76	Clinical Study Site	Kampung Baharu Nilai		Malaysia
77	Clinical Study Site #1	Kuala Lumpur		Malaysia
78	Clinical Study Site #2	Kuala Lumpur		Malaysia
79	Clinical Study Site	Kuching		Malaysia
80	Clinical Study Site	Pulau Pinang		Malaysia
81	Clinical Study Site	Tanjong Bungah		Malaysia
82	Clinical Study Site	Coahuila		Mexico
83	Clinical Study Site	Cuautitlán		Mexico
84	Clinical Study Site	Jalisco		Mexico
85	Clinical Study Site	León de los Aldama		Mexico
86	Clinical Study Site 1	Monterrey		Mexico
87	Clinical Study Site 2	Monterrey		Mexico
88	Clinical Study Site 3	Monterrey		Mexico
89	Clinical Study Site	Oaxaca		Mexico
90	Clinical Study Site	San Luis Potosí		Mexico
91	Clinical Study Site	Bacolod City		Philippines
92	Clinical Study Site	Batangas		Philippines
93	Clinical Study Site	Cebu		Philippines
94	Clinical Study Site	Davao City		Philippines
95	Clinical Study Site 1	Manila		Philippines
96	Clinical Study Site 2	Manila		Philippines
97	Clinical Study Site #1	Quezon City		Philippines
98	Clinical Study Site #2	Quezon City		Philippines
99	Clinical Study Site	Taguig		Philippines
100	Clinical Study Site	Dąbrowa Górnicza		Poland
101	Clinical Study Site	Gdynia		Poland
102	Clinical Study Site	Kraków		Poland
103	Clinical Study Site	Olsztyn		Poland
104	Clinical Study Site	Poznań		Poland
105	Clinical Study Site	Prabuty		Poland
106	Clinical Study Site	Radom		Poland
107	Clinical Study Site	Rzeszów		Poland
108	Clinical Study Site	Toruń		Poland
109	Clinical Study Site	Warszawa		Poland
110	Clinical Study Site	Wodzisław Śląski		Poland
111	Clinical Study Site	Łódź		Poland
112	Clinical Study Site 1	Craiova		Romania
113	Clinical Study Site 2	Craiova		Romania
114	Clinical Study Site	Floreşti		Romania
115	Clinical Study Site	Ploieşti		Romania
116	Clinical Study Site	Timişoara		Romania
117	Clinical Study Site	Ufa	Republic Bashkortost	Russian Federation
118	Clinical Study Site	Pushkin	Saint Petersburg	Russian Federation
119	Clinical Study Site	Arkhangel'sk		Russian Federation
120	Clinical Study Site	Belgorod		Russian Federation
121	Clinical Study Site	Chelyabinsk		Russian Federation
122	Clinical Study Site	Kaluga		Russian Federation
123	Clinical Study Site	Kazan		Russian Federation
124	Clinical Study Site	Kemerovo		Russian Federation
125	Clinical Study Site	Kislino		Russian Federation
126	Clinical Study Site	Kursk		Russian Federation
127	Clinical Study Site 1	Moscow		Russian Federation
128	Clinical Study Site 2	Moscow		Russian Federation
129	Clinical Study Site 3	Moscow		Russian Federation
130	Clinical Study Site	Omsk		Russian Federation
131	Clinical Study Site	Pyatigorsk		Russian Federation
132	Clinical Study Site 1	Saint Petersburg		Russian Federation
133	Clinical Study Site 2	Saint Petersburg		Russian Federation
134	Clinical Study Site 3	Saint Petersburg		Russian Federation
135	Clinical Study Site 4	Saint Petersburg		Russian Federation
136	Clinical Study Site	Samara		Russian Federation
137	Clinical Study Site	Saransk		Russian Federation
138	Clinical Study Site	Sochi		Russian Federation
139	Clinical Study Site 1	Tomsk		Russian Federation
140	Clinical Study Site 2	Tomsk		Russian Federation
141	Clinical Study Site	Yekaterinburg		Russian Federation
142	Clinical Study Site	Manresa	Barcelona	Spain
143	Clinical Study Site	Barcelona		Spain
144	Clinical Study Site	Pamplona		Spain
145	Clinical Study Site	Chang Hua		Taiwan
146	Clinical Study Site	Hualien City		Taiwan
147	Clinical Study Site 1	Kaohsiung		Taiwan
148	Clinical Study Site 2	Kaohsiung		Taiwan
149	Clinical Study Site 1	New Taipei City		Taiwan
150	Clinical Study Site 2	New Taipei		Taiwan
151	Clinical Study Site 1	Taichung		Taiwan
152	Clinical Study Site 2	Taichung		Taiwan
153	Clinical Study Site 1	Taipei		Taiwan
154	Clinical Study Site 2	Taipei		Taiwan
155	Clinical Study Site 3	Taipei		Taiwan
156	Clinical Study Site	Lop Buri	Muang	Thailand
157	Clinical Study Site	Hat Yai	Songkhla	Thailand
158	Clinical Study Site #1	Bangkok		Thailand
159	Clinical Study Site #2	Bangkok		Thailand
160	Clinical Study Site	Chiang Rai		Thailand
161	Clinical Study Site	Khon Kaen		Thailand
162	Clinical Study Site	Lampang		Thailand
163	Clinical Study Site	Phitsanulok		Thailand
164	Clinical Study Site	Ratchathewi		Thailand
165	Clinical Study Site	Udon Thani		Thailand
166	Clinical Study Site 1	Adana		Turkey
167	Clinical Study Site 2	Adana		Turkey
168	Clinical Study Site 1	Ankara		Turkey
169	Clinical Study Site 2	Ankara		Turkey
170	Clinical Study Site 3	Ankara		Turkey
171	Clinical Study Site 4	Ankara		Turkey
172	Clinical Study Site 5	Ankara		Turkey
173	Clinical Study Site	Edirne		Turkey
174	Clinical Study Site 1	Istanbul		Turkey
175	Clinical Study Site 2	Istanbul		Turkey
176	Clinical Study Site 3	Istanbul		Turkey
177	Clinical Study Site 4	Istanbul		Turkey
178	Clinical Study Site 1	İzmir		Turkey
179	Clinical Study Site 2	İzmir		Turkey
180	Clinical Study Site 3	İzmir		Turkey
181	Clinical Study Site	Samsun		Turkey
182	Clinical Study Site	Dnepropetrovsk		Ukraine
183	Clinical Study Site	Ivano-Frankivs'k		Ukraine
184	Clinical Study Site	Kharkiv		Ukraine
185	Clinical Study Site	Kherson		Ukraine
186	Clinical Study Site 1	Kiev		Ukraine
187	Clinical Study Site 2	Kiev		Ukraine
188	Clinical Study Site	Kirovohrad		Ukraine
189	Clinical Study Site 1	Kyiv		Ukraine
190	Clinical Study Site 2	Kyiv		Ukraine
191	Clinical Study Site	Vinnytsia		Ukraine
192	Clinical Study Site	Zaporozhye		Ukraine
193	Clinical Study Site	Úzhgorod		Ukraine

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03088540
• Other Study ID Numbers: R2810-ONC-1624; 2016-004407-31
• First Posted: Mar 23, 2017
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Regeneron Pharmaceuticals: Previous Smoker; Current Smoker; Stage IIIB; Stage IIIC; Stage IV; PD-L1
• Additional relevant MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Gemcitabine; Paclitaxel; Carboplatin; Pemetrexed; Cemiplimab

Study Results

No Results Posted as of Jun 22, 2022