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

May 14, 2026 updated by: Regeneron Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
789

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1130
        • Regeneron Research Site
  • China
      • Baoding, China, 071105
        • Regeneron Research Site
      • Beijing, China, 100050
        • Regeneron Research Site
      • Changsha, China, 410013
        • Regeneron Research Site
      • Guangzhou, China, 510080
        • Regeneron Research Site
      • Hangzhou, China, 310003
        • Regeneron Research Site
      • Hangzhou, China, 310009
        • Regeneron Research Site
      • Hangzhou, China, 310013
        • Regeneron Research Site
      • Hangzhou, China, 310002
        • Regeneron Research Site
      • Jinan, China, 250013
        • Regeneron Research Site
      • Linyi, China, 276001
        • Regeneron Research Site
      • Nanjing, China, 210003
        • Regeneron Research Site
      • Shanghai, China, 200040
        • Regeneron Research Site
      • Shanghai, China, 200433
        • Regeneron Research Site
      • Shenyang, China, 110042
        • Regeneron Research Site
      • Xiangyang, China, 441021
        • Regeneron Research Site
      • Zhengzhou, China, 450008
        • Regeneron Research Site
      • Zhengzhou, China, 450003
        • Regeneron Research Site
  • France
      • Bayonne, France, 64100
        • Regeneron Research Site
      • Créteil, France, 94010
        • Regeneron Research Site
      • Le Mans, France, 72000
        • Regeneron Research Site
      • Lille, France, 59037
        • Regeneron Research Site
      • Lyon, France, 69310
        • Regeneron Research Site
      • Mont-de-Marsan, France, 40024
        • Regeneron Research Site
      • Saint-Herblain, France, 44805
        • Regeneron Research Site
      • Saint-Mandé, France, 94160
        • Regeneron Research Site
      • Strasbourg, France, 67091
        • Regeneron Research Site
  • Georgia
      • Batumi, Georgia, 6000
        • Regeneron Research Site
      • Tbilisi, Georgia, 0112
        • Regeneron Research Site
      • Tbilisi, Georgia, 0144
        • Regeneron Research Site
      • Tbilisi, Georgia, 0159
        • Regeneron Research Site #1
      • Tbilisi, Georgia, 0159
        • Regeneron Research Site #2
      • Tbilisi, Georgia, 0186
        • Regeneron Research Site
  • Greece
      • Athens, Greece, 11527
        • Regeneron Research Site
      • Kifissia, Greece, 14564
        • Regeneron Research Site
      • Larissa, Greece, 41334
        • Regeneron Research Site
      • Pylaia, Greece, 57001
        • Regeneron Research Site
      • Thessaloniki, Greece, 54007
        • Regeneron Research Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 54645
        • Regeneron Research Site
  • Ireland
      • Dublin, Ireland, 9
        • Regeneron Research Site
      • Limerick, Ireland, V94F858
        • Regeneron Research Site
  • Italy
      • Cremona, Italy, 26100
        • Regeneron Research Site
      • Meldola, Italy, 47014
        • Regeneron Research Site
      • Milan, Italy, 20162
        • Regeneron Research Site
      • Monserrato, Italy, 09042
        • Regeneron Research Site
      • Piacenza, Italy, 29121
        • Regeneron Research Site
      • Saronno, Italy, 21047
        • Regeneron Research Site
      • Terni, Italy, 05100
        • Regeneron Research Site
      • Treviglio, Italy, 24047
        • Regeneron Research Site
  • Lithuania
      • Klaipėda, Lithuania, LT-92288
        • Regeneron Research Site
      • Vilnius, Lithuania, LT-08660
        • Regeneron Research Site
  • Malaysia
      • George Town, Malaysia, 10350
        • Regeneron Research Site
      • Johor Bahru, Malaysia, 81100
        • Regeneron Research Site
      • Kota Kinabalu, Malaysia, 88996
        • Regeneron Research Site
      • Kuala Lumpur, Malaysia, 56000
        • Regeneron Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Regeneron Research Site
      • Kuantan, Malaysia, 25100
        • Regeneron Research Site
      • Pulau Pinang, Malaysia, 10990
        • Regeneron Research Site
      • Tanjung Bungah, Malaysia, 11200
        • Regeneron Research Site
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Regeneron Research Site
  • Poland
      • Lodz, Poland, 90-302
        • Regeneron Research Site
      • Lublin, Poland, 20-093
        • Regeneron Research Site
      • Olsztyn, Poland, 10-357
        • Regeneron Research Site
      • Otwock, Poland, 05-400
        • Regeneron Research Site
      • Poznan, Poland, 60-693
        • Regeneron Research Site
      • Rzeszów, Poland, 35-021
        • Regeneron Research Site
      • Torun, Poland, 87-100
        • Regeneron Research Site
      • Wodzisław Śląski, Poland, 44-300
        • Regeneron Research Site
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Regeneron Research Site
  • Romania
      • Cluj-Napoca, Romania, 400006
        • Regeneron Research Site
      • Cluj-Napoca, Romania, 400124
        • Regeneron Research Site
      • Craiova, Romania, 200094
        • Regeneron Research Site
      • Craiova, Romania, 200347
        • Regeneron Research Site
      • Craiova, Romania, 200385
        • Regeneron Research Site
  • Russia
      • Arkhangelsk, Russia, 163045
        • Regeneron Research Site
      • Belgorod, Russia, 308010
        • Regeneron Research Site
      • Chelyabinsk, Russia, 454048
        • Regeneron Research Site
      • Kaluga, Russia, 248007
        • Regeneron Research Site
      • Kazan', Russia, 420029
        • Regeneron Research Site
      • Kursk, Russia, 305016
        • Regeneron Research Site
      • Moscow, Russia, 115478
        • Regeneron Research Site
      • Moscow, Russia, 121467
        • Regeneron Research Site
      • Moscow Region, Russia, 143444
        • Regeneron Research Site
      • Omsk, Russia, 644013
        • Regeneron Research Site
      • Pushkin, Russia, 196603
        • Regeneron Research Site
      • Pyatigorsk, Russia, 357502
        • Regeneron Research Site
      • Saint Petersburg, Russia, 191104
        • Regeneron Research Site
      • Saint Petersburg, Russia, 197758
        • Regeneron Research Site
      • Saint Petersburg, Russia, 198255
        • Regeneron Research Site
      • Samara, Russia, 443001
        • Regeneron Research Site
      • Saransk, Russia, 430032
        • Regeneron Research Site
      • Sochi, Russia, 354057
        • Regeneron Research Site
      • Tomsk, Russia, 634028
        • Regeneron Research Site
      • Tomsk, Russia, 634050
        • Regeneron Research Site
      • Yekaterinburg, Russia, 620036
        • Regeneron Research Site
    • Republic Bashkortost
      • Ufa, Republic Bashkortost, Russia, 450054
        • Regeneron Research Site
  • Slovakia
      • Banka, Slovakia, 92101
        • Regeneron Research Site
  • South Korea
      • Cheongju-si, South Korea, 28644
        • Regeneron Research Site
      • Incheon, South Korea, 21565
        • Regeneron Research Site
      • Jeonju, South Korea, 54907
        • Regeneron Research Site
      • Seongnam-si, South Korea, 13496
        • Regeneron Research Site
      • Seongnam-si, South Korea, 13620
        • Regeneron Research Site
      • Seoul, South Korea, 05368
        • Regeneron Research Site
      • Seoul, South Korea, 05505
        • Regeneron Research Site
      • Seoul, South Korea, 06351
        • Regeneron Research Site
      • Suwon, South Korea, 16499
        • Regeneron Research Site
  • Thailand
      • Muang, Thailand, 15000
        • Regeneron Research Site
      • Ratchathewi, Thailand, 10400
        • Regeneron Research Site #1
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Regeneron Research Site #2
    • Changwat Chiang Rai
      • Muang, Changwat Chiang Rai, Thailand, 57000
        • Regeneron Research Site
    • Changwat Lampang
      • A. Mueang, Changwat Lampang, Thailand, 52000
        • Regeneron Research Site
    • Changwat Phitsanulok
      • Muang, Changwat Phitsanulok, Thailand, 65000
        • Regeneron Research Site
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Regeneron Research Site
    • Udonthani
      • Udon Thani, Udonthani, Thailand, 41330
        • Regeneron Research Site
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01120
        • Regeneron Research Site
      • Ankara, Turkey (Türkiye), 06100
        • Regeneron Research Site
      • Istanbul, Turkey (Türkiye), 34000
        • Regeneron Research Site
      • Istanbul, Turkey (Türkiye), 34093
        • Regeneron Research Site
  • Ukraine
      • Dnipro, Ukraine, 49102
        • Regeneron Research Site
      • Kharkiv, Ukraine, 61070
        • Regeneron Research Site
      • Kiev, Ukraine, 03022
        • Regeneron Research Site
      • Kirovohrad, Ukraine, 25006
        • Regeneron Research Site
      • Uzhhorod, Ukraine, 88014
        • Regeneron Research Site
      • Vinnytsia, Ukraine, 21029
        • Regeneron Research Site
  • United States
    • California
      • Rancho Mirage, California, United States, 92270
        • Regeneron Research Site
      • Riverside, California, United States, 92506
        • Regeneron Research Site
      • Whittier, California, United States, 90603
        • Regeneron Research Site
    • Florida
      • Orange City, Florida, United States, 32763
        • Regeneron Research Site
      • St. Petersburg, Florida, United States, 33709
        • Regeneron Research Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Regeneron Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Regeneron Research Site
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • Regeneron Research Site
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Regeneron Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Chemo
Part 1: Chemotherapy
Other: Chemotherapy
Platinum-based doublet chemotherapy Part 1
Drug: Placebo
Matching placebo Part 2
Experimental: REGN2810+Chemo Part 1
Part 1: REGN2810+chemo
Drug: REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
Other Names:
  • cemiplimab
Experimental: REGN2810+AbbrevChemo+ipi
Part 1: REGN2810+abbrev chemo+ipi
Drug: REGN2810/chemo/ipi
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
Other Names:
  • cemiplimab
Experimental: Placebo+Chemo
Part 2: Placebo plus chemo
Drug: Placebo
Matching placebo Part 2
Experimental: REGN2810+Chemo Part 2
Part 2: REGN2810+chemo
Drug: REGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
Other Names:
  • cemiplimab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Overall Survival (OS)
Time Frame: Up to a maximum of 82.2 months
OS was defined as the time from randomization to the date of death due to any cause.
Up to a maximum of 82.2 months
Part 2: OS
Time Frame: Up to a maximum of 68.4 months
OS was defined as the time from randomization to the date of death due to any cause.
Up to a maximum of 68.4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1: Progression-free Survival (PFS) Per Independent Review Committee (IRC)
Time Frame: Up to a maximum of 82.2 months
PFS as assessed by IRC per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
Up to a maximum of 82.2 months
Part 2: PFS Per IRC
Time Frame: Up to a maximum of 68.4 months
PFS as assessed by IRC per RECIST 1.1 was defined as the time from randomization to the date of the first documented tumor progression, or death due to any cause, whichever occurred earlier.
Up to a maximum of 68.4 months
Part 1: Objective Response Rate (ORR) Per IRC
Time Frame: Up to 32 months
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR).
Up to 32 months
Part 2: ORR Per IRC
Time Frame: Up to 32 months
ORR as assessed by IRC per RECIST 1.1 was defined as the percentage of participants with a BOR of confirmed CR or PR.
Up to 32 months
Part 1: Duration of Response (DoR)
Time Frame: Up to 32 months
DoR was defined as the time from date of first documented response of CR or PR to the date of first documented progressive disease (PD) or death due to any cause, whichever occurred earlier.
Up to 32 months
Part 2: DoR
Time Frame: Up to 32 months
DoR was defined as the time from date of first documented response of CR or PR to the date of first documented PD or death due to any cause, whichever occurred earlier.
Up to 32 months
Part 1: Best Overall Response (BOR) Per IRC
Time Frame: Up to 32 months
BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
Up to 32 months
Part 2: BOR Per IRC
Time Frame: Up to 32 months
BOR was defined as the best overall response as determined by the IRC per RECIST 1.1, between the date of randomization and the date of first documented tumor progression or the date of subsequent anti-cancer therapy, whichever occurred earlier.
Up to 32 months
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug in Part 1, up to approximately 83 months
TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With TEAEs
Time Frame: From first dose of study drug in Part 2, up to approximately 69 months
TEAEs were AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Time Frame: 28 days
Part 1 only
28 days
Part 1: Number of Participants With Serious TEAEs
Time Frame: From first dose of study drug in Part 1, up to approximately 83 months
Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
From first dose of study drug in Part 1, up to approximately 83 months
Part 2: Number of Participants With Serious TEAEs
Time Frame: From first dose of study drug in Part 2, up to approximately 69 months
Serious TEAEs were defined as medically significant but not immediately life-threatening AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occurred during the post-treatment period but prior to start of another anti-cancer systemic therapy.
From first dose of study drug in Part 2, up to approximately 69 months
Part 1: Number of Deaths During the On-Treatment Period
Time Frame: Up to 28 months
The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.
Up to 28 months
Part 2: Number of Deaths During the On-Treatment Period
Time Frame: Up to 28 months
The on-treatment period was defined as the day from the first dose of study drug to the day of the last dose of study drug plus 90 days or 1 day before participants receive their first dose of new anti-cancer systemic therapy, whichever is earlier.
Up to 28 months
Part 1: Estimated Survival Probability
Time Frame: 12 months, 18 months, 24 months
OS rate at a landmark (12, 18, and 24 months) was defined as the Kaplan-Meier (K-M) estimated probability of participants who survived due to any cause at the landmark after randomization.
12 months, 18 months, 24 months
Part 2: Estimated Survival Probability
Time Frame: 12 months, 18 months, 24 months
OS rate at a landmark (12, 18, and 24 months) was defined as the K-M estimated probability of participants who survived due to any cause at the landmark after randomization.
12 months, 18 months, 24 months
Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.
Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
Part 2: Change From Baseline in Global Health Status Score as Measured by the EORTC QLQ-C30
Time Frame: Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36; Follow-up 1 (14 to 30 days after last study treatment)
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.
Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36; Follow-up 1 (14 to 30 days after last study treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R2810-ONC-16113
  • 2017-001311-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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