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

Primary Purpose

Non-small Cell Lung Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

REGN2810

REGN2810/chemo/ipi

Chemotherapy

Placebo

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Stage IIIB, Stage IIIC, Stage IV, Non-squamous NSCLC, Squamous NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Men and women ≥20 years of age for Japanese patients
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
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
Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
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
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
Active or untreated brain metastases or spinal cord compression
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
Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment
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
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)
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Experimental

Arm Label

Chemo

REGN2810+Chemo Part 1

REGN2810+AbbrevChemo+ipi

Placebo+Chemo

REGN2810+Chemo Part 2

Arm Description

Part 1: Chemotherapy

Part 1: REGN2810+chemo

Part 1: REGN2810+abbrev chemo+ipi

Part 2: Placebo plus chemo

Part 2: REGN2810+chemo

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival

Objective response rate

Duration of Response (DOR)

Best overall response (BOR)

Incidence of Treatment-emergent adverse events (TEAEs)

Incidence of Dose-limiting toxicities (DLTs)

Part 1 only

Incidence of serious adverse events (SAEs)

Incidence of deaths

Incidence of laboratory abnormalities

Overall survival rate

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)

Quality of life as measured by EORTC QLQ-LC13

Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

Full Information

NCT ID

NCT03409614

First Posted

January 10, 2018

Last Updated

July 28, 2023

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT03409614

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 6, 2018 (Actual)

Primary Completion Date

July 6, 2023 (Actual)

Study Completion Date

January 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

Stage IIIB, Stage IIIC, Stage IV, Non-squamous NSCLC, Squamous NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Part 1: Open label Part 2: Double blind

Allocation

Randomized

Enrollment

790 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemo

Arm Type

Other

Arm Description

Part 1: Chemotherapy

Arm Title

REGN2810+Chemo Part 1

Arm Type

Experimental

Arm Description

Part 1: REGN2810+chemo

Arm Title

REGN2810+AbbrevChemo+ipi

Arm Type

Experimental

Arm Description

Part 1: REGN2810+abbrev chemo+ipi

Arm Title

Placebo+Chemo

Arm Type

Experimental

Arm Description

Part 2: Placebo plus chemo

Arm Title

REGN2810+Chemo Part 2

Arm Type

Experimental

Arm Description

Part 2: REGN2810+chemo

Intervention Type

Drug

Intervention Name(s)

REGN2810

Other Intervention Name(s)

cemiplimab

Intervention Description

REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2

Intervention Type

Drug

Intervention Name(s)

REGN2810/chemo/ipi

Other Intervention Name(s)

cemiplimab

Intervention Description

REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1

Intervention Type

Other

Intervention Name(s)

Chemotherapy

Intervention Description

Platinum-based doublet chemotherapy Part 1

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo Part 2

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

Up to 32 months

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

Up to 32 months

Title

Objective response rate

Time Frame

Up to 32 months

Title

Duration of Response (DOR)

Time Frame

Up to 32 months

Title

Best overall response (BOR)

Time Frame

Up to 32 months

Title

Incidence of Treatment-emergent adverse events (TEAEs)

Time Frame

Up to 32 months

Title

Incidence of Dose-limiting toxicities (DLTs)

Description

Part 1 only

Time Frame

Up to 32 months

Title

Incidence of serious adverse events (SAEs)

Time Frame

Up to 32 months

Title

Incidence of deaths

Time Frame

Up to 32 months

Title

Incidence of laboratory abnormalities

Time Frame

Up to 32 months

Title

Overall survival rate

Time Frame

12 months

Title

Overall survival rate

Time Frame

18 months

Title

Overall survival rate

Time Frame

24 months

Title

Quality of life as measured by EORTC QLQ-C30

Description

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Time Frame

Up to 32 months

Title

Quality of life as measured by EORTC QLQ-LC13

Description

Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

Time Frame

Up to 32 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Men and women ≥20 years of age for Japanese patients 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 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 Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory 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 Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Anticipated life expectancy of at least 3 months Key Exclusion Criteria: Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime Active or untreated brain metastases or spinal cord compression 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 Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment 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 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trial Management

Organizational Affiliation

Regeneron Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Regeneron Research Site

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Regeneron Research Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Regeneron Research Site

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

Regeneron Research Site

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

Regeneron Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Facility Name

Regeneron Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Regeneron Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Regeneron Research Site

City

Farmington

State/Province

New Mexico

ZIP/Postal Code

87401

Country

United States

Facility Name

Regeneron Research Site

City

Gettysburg

State/Province

Pennsylvania

ZIP/Postal Code

17325

Country

United States

Facility Name

Regeneron Research Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Regeneron Research Site

City

Baoding

ZIP/Postal Code

071105

Country

China

Facility Name

Regeneron research Site

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Regeneron Research Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Regeneron Research Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Regeneron Research Site

City

Hangzhou Shi

ZIP/Postal Code

310002

Country

China

Facility Name

Regeneron Research Site

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

Regeneron Research Site

City

Hangzhou

ZIP/Postal Code

310009

Country

China

Facility Name

Regeneron Research Site

City

Hangzhou

ZIP/Postal Code

310013

Country

China

Facility Name

Regeneron Research Site

City

Jinan

ZIP/Postal Code

250013

Country

China

Facility Name

Regeneron Research Site

City

Linyi City

ZIP/Postal Code

276001

Country

China

Facility Name

Regeneron Research Site

City

Nanjing Shi

ZIP/Postal Code

210003

Country

China

Facility Name

Regeneron Research Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

Regeneron Research Site

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

Regeneron Research Site

City

Shenyang

ZIP/Postal Code

110042

Country

China

Facility Name

Regeneron Research Site

City

Xiangyang Shi

ZIP/Postal Code

441021

Country

China

Facility Name

Regeneron Research Site

City

Zhengzhou City

ZIP/Postal Code

450003

Country

China

Facility Name

Regeneron Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Regeneron Research Site

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Regeneron Research Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Regeneron Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Regeneron Research Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Regeneron Research Site

City

Lyon

ZIP/Postal Code

69310

Country

France

Facility Name

Regeneron Research Site

City

Mont-de-Marsan

ZIP/Postal Code

40024

Country

France

Facility Name

Regeneron Research Site

City

Saint Herblain Cedex

ZIP/Postal Code

44805

Country

France

Facility Name

Regeneron Research Site

City

Saint-Mandé

ZIP/Postal Code

94160

Country

France

Facility Name

Regeneron Research Site

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Regeneron Research Site

City

Batumi

ZIP/Postal Code

6000

Country

Georgia

Facility Name

Regeneron Research Site

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

Regeneron Research Site

City

Tbilisi

ZIP/Postal Code

0144

Country

Georgia

Facility Name

Regeneron Research Site #1

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Regeneron Research Site #2

City

Tbilisi

ZIP/Postal Code

0159

Country

Georgia

Facility Name

Regeneron Research Site

City

Tbilisi

ZIP/Postal Code

0186

Country

Georgia

Facility Name

Regeneron Research Site

City

Thessaloniki

State/Province

Macedonia

ZIP/Postal Code

54645

Country

Greece

Facility Name

Regeneron Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Regeneron Research Site

City

Kifisia

ZIP/Postal Code

14564

Country

Greece

Facility Name

Regeneron Research Site

City

Larissa

ZIP/Postal Code

41334

Country

Greece

Facility Name

Regeneron Research Site

City

Pylaia

ZIP/Postal Code

57001

Country

Greece

Facility Name

Regeneron Research Site

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

Regeneron Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Regeneron Research Site

City

Limerick

ZIP/Postal Code

V94F858

Country

Ireland

Facility Name

Regeneron Research Site

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Regeneron Research Site

City

Meldola

ZIP/Postal Code

47014

Country

Italy

Facility Name

Regeneron Research Site

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Regeneron Research Site

City

Monserrato

ZIP/Postal Code

09042

Country

Italy

Facility Name

Regeneron Research Site

City

Piacenza

ZIP/Postal Code

29121

Country

Italy

Facility Name

Regeneron Research Site

City

Saronno

ZIP/Postal Code

21047

Country

Italy

Facility Name

Regeneron Research Site

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

Regeneron Research Site

City

Treviglio

ZIP/Postal Code

24047

Country

Italy

Facility Name

Regeneron Research Site

City

Cheongju-si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Jeonju

ZIP/Postal Code

54907

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seongnam-si

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

05368

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Suwon-si

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Regeneron Research Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Regeneron Research Site

City

Vilnius

ZIP/Postal Code

LT-08660

Country

Lithuania

Facility Name

Regeneron Research Site

City

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Regeneron Research Site

City

Johor Bahru

ZIP/Postal Code

81100

Country

Malaysia

Facility Name

Regeneron Research Site

City

Kota Kinabalu

ZIP/Postal Code

88996

Country

Malaysia

Facility Name

Regeneron Research Site

City

Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

Facility Name

Regeneron Research Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Regeneron Research Site

City

Kuantan

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

Regeneron Research Site

City

Penang

ZIP/Postal Code

10350

Country

Malaysia

Facility Name

Regeneron Research Site

City

Pulau Pinang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Regeneron Research Site

City

Tanjung Bungah

ZIP/Postal Code

11200

Country

Malaysia

Facility Name

Regeneron Research Site

City

Gdynia

State/Province

Pomorskie

ZIP/Postal Code

81-519

Country

Poland

Facility Name

Regeneron Research Site

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Regeneron Research Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Regeneron Research Site

City

Otwock

ZIP/Postal Code

05-400

Country

Poland

Facility Name

Regeneron Research Site

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Regeneron Research Site

City

Rzeszow

ZIP/Postal Code

35-021

Country

Poland

Facility Name

Regeneron Research Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Regeneron Research Site

City

Wodzisław Śląski

ZIP/Postal Code

44-300

Country

Poland

Facility Name

Regeneron Research Site

City

Łódź

ZIP/Postal Code

90-302

Country

Poland

Facility Name

Regeneron Research Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Regeneron Research Site

City

Cluj Napoca

ZIP/Postal Code

400124

Country

Romania

Facility Name

Regeneron Research Site

City

Craiova

ZIP/Postal Code

200094

Country

Romania

Facility Name

Regeneron Research Site

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

Regeneron Research Site

City

Craiova

ZIP/Postal Code

200385

Country

Romania

Facility Name

Regeneron Research Site

City

Ufa

State/Province

Republic Bashkortost

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Arkhangel'sk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Belgorod

ZIP/Postal Code

308010

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Chelyabinsk

ZIP/Postal Code

454048

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Ekaterinburg

ZIP/Postal Code

620036

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Kursk

ZIP/Postal Code

305016

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Moscow region

ZIP/Postal Code

143444

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Moscow

ZIP/Postal Code

121467

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Pushkin

ZIP/Postal Code

196603

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Pyatigorsk

ZIP/Postal Code

357502

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Saint Petersburg

ZIP/Postal Code

191104

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Saint Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Samara

ZIP/Postal Code

443001

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Saransk

ZIP/Postal Code

430032

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Sochi

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Tomsk

ZIP/Postal Code

634028

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Regeneron Research Site

City

Banka

ZIP/Postal Code

92101

Country

Slovakia

Facility Name

Regeneron Research Site #2

City

Ratchathewi

State/Province

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Regeneron Research Site

City

Muang

State/Province

Chiang Rai

ZIP/Postal Code

57000

Country

Thailand

Facility Name

Regeneron Research Site

City

A. Mueang

State/Province

Lampang

ZIP/Postal Code

52000

Country

Thailand

Facility Name

Regeneron Research Site

City

Muang

State/Province

Phitsanulok

ZIP/Postal Code

65000

Country

Thailand

Facility Name

Regeneron Research Site

City

Hat Yai

State/Province

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Regeneron Research Site

City

Muang

ZIP/Postal Code

15000

Country

Thailand

Facility Name

Regeneron Research Site #1

City

Ratchathewi

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Regeneron Research Site

City

Udonthani

ZIP/Postal Code

41330

Country

Thailand

Facility Name

Regeneron Research Site

City

Adana

ZIP/Postal Code

01120

Country

Turkey

Facility Name

Regeneron Research Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Regeneron Research Site

City

Istanbul

ZIP/Postal Code

34000

Country

Turkey

Facility Name

Regeneron Research Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Regeneron Research Site

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Regeneron Research Site

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Regeneron Research Site

City

Kiev

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Regeneron Research Site

City

Kirovohrad

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

Regeneron Research Site

City

Uzhgorod

ZIP/Postal Code

88014

Country

Ukraine

Facility Name

Regeneron Research Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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

Non-small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial