Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001041-27 | EudraCT Number |
Not provided
Not provided
Not provided
Business decision
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Active Comparator | Pembrolizumab |
|
| REGN2810/ipi | Experimental | REGN2810/ipi |
|
| REGN2810/chemo/ipi | Experimental | REGN2810/chemo/ipi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN2810/ipi | Drug | REGN2810 plus ipilimumab |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments | Per protocol, the final analysis of PFS was to be performed after observing 142 PFS events in the pembrolizumab treatment arm. PFS was not assessed due to insufficient data collected. | Up to 32 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | Up to 32 months |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Site | St. Petersburg | Florida | 33709 | United States | ||
| Regeneron Research Site |
Due to program de-prioritization, the sponsor decided to cease enrollment at which time only 5 participants were randomized to 2 of 3 treatment arms (i.e., no participants were randomized to receive pembrolizumab).
This study was conducted at 3 centers that randomized 5 participants in the United States, Lithuania, and Italy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Due to ceasing enrollment early, no participants were randomized to receive pembrolizumab. |
| FG001 | Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an intravenous (IV) infusion every 3 weeks (Q3W) for 108 weeks in combination with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2018 | Jul 28, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| REGN2810/chemo/ipi | Drug | REGN2810 plus chemotherapy plus Ipilimumab |
|
|
| Pembrolizumab | Drug | Reference drug administered IV infusion |
|
| Objective Response Rate (ORR) | Per protocol, the ORR for each cemiplimab combination-versus-pembrolizumab comparison was to be analyzed using the Cochran-Mantel-Haenszel test stratified by histological status (non-squamous versus squamous). | Up to 32 months |
| Number of Treatment-Emergent Adverse Events (TEAEs) | Up to 32 months |
| Number of Participants With Dose-Limiting Toxicities (DLTs) | Up to 32 months |
| Number of Participants With Any Serious TEAEs | Up to 32 months |
| Number of Participants With TEAEs Leading to Death | Up to 32 months |
| Number of Participants With Laboratory Abnormalities | Up to 32 months |
| Overall Survival (OS) at 12 Months | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | At 12 months |
| Overall Survival (OS) at 18 Months | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | At 18 months |
| Quality of Life (Core 30 Questionnaire) | Quality of Life (QoL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) four-point scale, with 1 as "not at all" and 4 as "very much." Per protocol, the change in EORTC QLQ-C30 scores from the first assessment to the end of the study were to be summarized descriptively at each post-baseline time point and compared using a mixed effects model, if appropriate. | Up to 32 months |
| Quality of Life (Lung Cancer 13 Questionnaire) | QoL as measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much." Per protocol, the change in EORTC QLQ-LC13 scores from the first assessment to the end of the study were to be summarized descriptively at each post-baseline time point and compared using a mixed effects model, if appropriate. | Up to 32 months |
| Cremona |
| 26100 |
| Italy |
| Regeneron Research Site | Vilnius | 08660 | Lithuania |
| FG002 | Cemiplimab 350 mg Q3W + Chemotherapy + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an IV infusion Q3W for 108 weeks in combination with platinum-based doublet chemotherapy administered IV Q3W for 2 cycles and with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. |
| COMPLETED | Completed study |
|
| NOT COMPLETED |
|
|
Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an intravenous (IV) infusion every 3 weeks (Q3W) for 108 weeks in combination with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. |
| BG001 | Cemiplimab 350 mg Q3W + Chemotherapy + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an IV infusion Q3W for 108 weeks in combination with platinum-based doublet chemotherapy administered IV Q3W for 2 cycles and with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments | Per protocol, the final analysis of PFS was to be performed after observing 142 PFS events in the pembrolizumab treatment arm. PFS was not assessed due to insufficient data collected. | PFS was not assessed due to insufficient data collected. | Posted | Up to 32 months |
|
| |||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | OS was not assessed due to insufficient data collected. | Posted | Up to 32 months |
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Per protocol, the ORR for each cemiplimab combination-versus-pembrolizumab comparison was to be analyzed using the Cochran-Mantel-Haenszel test stratified by histological status (non-squamous versus squamous). | ORR was not assessed due to insufficient data collected. | Posted | Up to 32 months |
| ||||||||||||||||||||||||||
| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) | Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment | Posted | Number | Events | Up to 32 months |
|
| ||||||||||||||||||||||||
| Secondary | Number of Participants With Dose-Limiting Toxicities (DLTs) | Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Up to 32 months |
|
| ||||||||||||||||||||||||
| Secondary | Number of Participants With Any Serious TEAEs | Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment | Posted | Count of Participants | Participants | Up to 32 months |
|
| ||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Leading to Death | Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment | Posted | Count of Participants | Participants | Up to 32 months |
|
| ||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities | Safety analysis set (SAF), defined as all enrolled participants who received any amount of study treatment | Posted | Count of Participants | Participants | Up to 32 months |
|
| ||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at 12 Months | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | OS was not assessed due to insufficient data collected. | Posted | At 12 months |
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) at 18 Months | Per protocol, if the final analysis of PFS was statistically significant for both cemiplimab combination therapy versus pembrolizumab treatment, the analysis of OS for cemiplimab combinations-versus-pembrolizumab comparison was to be performed at the time of PFS analysis, 12 months, and 18 months after analysis of PFS using the same method as used in the analysis of PFS. | OS was not assessed due to insufficient data collected. | Posted | At 18 months |
|
| |||||||||||||||||||||||||
| Secondary | Quality of Life (Core 30 Questionnaire) | Quality of Life (QoL) as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) four-point scale, with 1 as "not at all" and 4 as "very much." Per protocol, the change in EORTC QLQ-C30 scores from the first assessment to the end of the study were to be summarized descriptively at each post-baseline time point and compared using a mixed effects model, if appropriate. | Due to the minimal amount of responses and decrease in number of overall participants analyzed for this outcome measure, results are not reported to protect the confidentiality of the participants. | Posted | Mean | Standard Deviation | Score on a scale | Up to 32 months |
| |||||||||||||||||||||||
| Secondary | Quality of Life (Lung Cancer 13 Questionnaire) | QoL as measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much." Per protocol, the change in EORTC QLQ-LC13 scores from the first assessment to the end of the study were to be summarized descriptively at each post-baseline time point and compared using a mixed effects model, if appropriate. | Due to the minimal amount of responses and decrease in number of overall participants analyzed for this outcome measure, results are not reported to protect the confidentiality of the participants. | Posted | Median | Standard Deviation | Score on a scale | Up to 32 months |
|
From first dose of study drug to end of study (up to 32 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cemiplimab 350 mg Q3W + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an intravenous (IV) infusion every 3 weeks (Q3W) for 108 weeks in combination with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. | 2 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Cemiplimab 350 mg Q3W + Chemotherapy + Ipilimumab 50 mg Q6W | Cemiplimab was administered at 350 mg as an IV infusion Q3W for 108 weeks in combination with platinum-based doublet chemotherapy administered IV Q3W for 2 cycles and with ipilimumab administered IV over approximately 90 minutes at 50 mg Q6W for up to 4 doses. | 1 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Secondary adrenocortical insufficiency | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Suprapubic pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fungal oesophagitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Tumour pseudoprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2021 | Jul 28, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|