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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05785767
Registration number
NCT05785767
Ethics application status
Date submitted
14/03/2023
Date registered
27/03/2023
Titles & IDs
Public title
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
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Scientific title
A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 =50%
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Secondary ID [1]
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2022-501483-18-00
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Secondary ID [2]
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R3767-ONC-2235
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
0
0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - fianlimab
Treatment: Drugs - cemiplimab
Treatment: Drugs - Placebo
Experimental: A: fianlimab+cemiplimab - Phase 2: fianlimab (HD) Phase 3: fianlimab (chosen dose)
Experimental: B: fianlimab+cemiplimab - Phase 2: fianlimab (LD) Phase 3: fianlimab (chosen dose)
Experimental: C: cemiplimab monotherapy+placebo - Phase 2 and Phase 3
Treatment: Drugs: fianlimab
Every three weeks (Q3W) as intravenous (IV) co-infusion
Treatment: Drugs: cemiplimab
Q3W as IV co-infusion
Treatment: Drugs: Placebo
Q3W as IV co-infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective response rate (ORR) as assessed by blinded independent central review (BICR), using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
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Assessment method [1]
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Phase 2 Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)
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Timepoint [1]
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Up to 136 weeks
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Primary outcome [2]
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Overall survival (OS)
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Assessment method [2]
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Phase 3 The time from randomization to the date of death due to any cause
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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Phase 2 and Phase 3 A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment
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Timepoint [1]
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Up to 136 weeks
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Secondary outcome [2]
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Incidence of treatment-related TEAEs
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Assessment method [2]
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Phase 2 and Phase 3
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Timepoint [2]
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Up to 136 weeks
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Secondary outcome [3]
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Incidence of serious adverse events (SAEs)
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Assessment method [3]
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Phase 2 and Phase 3
Any untoward medical occurrence that at any dose:
* Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
* Is life-threatening
* Requires in-patient hospitalization or prolongation of existing hospitalization • Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Is an important medical event
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Timepoint [3]
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Up to 136 weeks
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Secondary outcome [4]
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Incidence of adverse events of special interest (AESIs)
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Assessment method [4]
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Phase 2 and Phase 3 Serious or non-serious; is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it.
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Timepoint [4]
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Up to 136 weeks
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Secondary outcome [5]
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Incidence of immune-mediated adverse events (imAEs)
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Assessment method [5]
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Phase 2 and Phase 3 Immune-mediated AEs are thought to be caused by unrestrained cellular immune responses directed at normal host tissues. An imAE can occur shortly after the first dose or several months after the last dose of treatment. Early detection and management reduces the risk of severe drug induced toxicity
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Timepoint [5]
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Up to 136 weeks
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Secondary outcome [6]
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Occurrence of interruption of study drug(s) due to TEAEs
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Assessment method [6]
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0
Phase 2 and Phase 3
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Timepoint [6]
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Up to 136 weeks
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Secondary outcome [7]
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Occurrence of discontinuation of study drug(s) due to TEAEs
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Assessment method [7]
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0
Phase 2 and Phase 3
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Timepoint [7]
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Up to 136 weeks
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Secondary outcome [8]
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Occurrence of interruption of study drug(s) due to AESIs
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Assessment method [8]
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Phase 2 and Phase 3
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Timepoint [8]
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Up to 136 weeks
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Secondary outcome [9]
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Occurrence of discontinuation of study drug(s) due to AESIs
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Assessment method [9]
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Phase 2 and Phase 3
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Timepoint [9]
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Up to 136 weeks
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Secondary outcome [10]
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Occurrence of interruption of study drug(s) due to imAEs
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Assessment method [10]
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Phase 2 and Phase 3
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Timepoint [10]
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Up to 136 weeks
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Secondary outcome [11]
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Occurrence of discontinuation of study drug(s) due to imAEs
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Assessment method [11]
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Phase 2 and Phase 3 A unique set of toxicities thought to be caused by unrestrained cellular immune responses
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Timepoint [11]
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Up to 136 weeks
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Secondary outcome [12]
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Incidence of deaths due to TEAE
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Assessment method [12]
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Phase 2 and Phase 3
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Timepoint [12]
0
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Up to 136 weeks
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Secondary outcome [13]
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Incidence of grade 3 to 4 laboratory abnormalities
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Assessment method [13]
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Phase 2 and Phase 3
= grade 3 per National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE v5.0\]
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Timepoint [13]
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Up to 136 weeks
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Secondary outcome [14]
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ORR by investigator assessment, using RECIST 1.1
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Assessment method [14]
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Phase 2
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Timepoint [14]
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Up to 136 weeks
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Secondary outcome [15]
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Disease control rate (DCR) by BICR
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Assessment method [15]
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Phase 2 and Phase 3 The proportion of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD)
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Timepoint [15]
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Up to 136 weeks
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Secondary outcome [16]
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DCR by investigator assessment
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Assessment method [16]
0
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Phase 2 and Phase 3
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Timepoint [16]
0
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Up to 136 weeks
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Secondary outcome [17]
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Time to tumor response (TTR) by BICR
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Assessment method [17]
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Phase 2 and Phase 3 The time from randomization to the date of the first response of CR or PR (whichever is first recorded) for patients with confirmed CR or PR.
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Timepoint [17]
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Up to 136 weeks
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Secondary outcome [18]
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TTR by investigator assessment
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Assessment method [18]
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Phase 2 and Phase 3
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Timepoint [18]
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Up to 136 weeks
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Secondary outcome [19]
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Duration of response (DOR) by BICR
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Assessment method [19]
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Phase 2 and Phase 3 The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR.
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Timepoint [19]
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Up to 5 years
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Secondary outcome [20]
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DOR by investigator assessment
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Assessment method [20]
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Phase 2 and Phase 3
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Timepoint [20]
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Up to 5 years
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Secondary outcome [21]
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Progression free survival (PFS) by BICR
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Assessment method [21]
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Phase 2 and Phase 3
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Timepoint [21]
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Up to 5 years
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Secondary outcome [22]
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PFS by investigator assessment
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Assessment method [22]
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0
Phase 2 and Phase 3
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Timepoint [22]
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Up to 5 years
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Secondary outcome [23]
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Overall survival (OS)
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Assessment method [23]
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Phase 2 The time from randomization to the date of death due to any cause
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Timepoint [23]
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Up to 5 years
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Secondary outcome [24]
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Change from baseline in patient-reported global health status/quality of life (GHS/QoL) per European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
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Assessment method [24]
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Phase 2 and Phase 3 EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a GHS/QoL scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.
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Timepoint [24]
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Up to 5 years
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Secondary outcome [25]
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Change from baseline in patient-reported physical functioning per EORTC QLQ-C30
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Assessment method [25]
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0
Phase 2 and Phase 3
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Timepoint [25]
0
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Up to 5 years
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Secondary outcome [26]
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Change from baseline in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC13)
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Assessment method [26]
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Phase 2 and Phase 3 EORTC QLQ-LC 13 is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients
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Timepoint [26]
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Up to 5 years
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Secondary outcome [27]
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0
Change from baseline in patient-reported dyspnea per EORTC QLQ-LC13
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Assessment method [27]
0
0
Phase 2 and Phase 3
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Timepoint [27]
0
0
Up to 5 years
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Secondary outcome [28]
0
0
Change from baseline in patient-reported cough per EORTC QLQ-LC13
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Assessment method [28]
0
0
Phase 2 and Phase 3
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Timepoint [28]
0
0
Up to 5 years
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Secondary outcome [29]
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Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
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Assessment method [29]
0
0
Phase 2 and Phase 3
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Timepoint [29]
0
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Up to 5 years
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Secondary outcome [30]
0
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Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30
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Assessment method [30]
0
0
Phase 2 and Phase 3
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Timepoint [30]
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Up to 5 years
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Secondary outcome [31]
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Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13
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Assessment method [31]
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0
Phase 2 and Phase 3
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Timepoint [31]
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Up to 5 years
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Secondary outcome [32]
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Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13
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Assessment method [32]
0
0
Phase 2 and Phase 3
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Timepoint [32]
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Up to 5 years
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Secondary outcome [33]
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0
Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13
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Assessment method [33]
0
0
Phase 2 and Phase 3
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Timepoint [33]
0
0
Up to 5 years
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Secondary outcome [34]
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Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13
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Assessment method [34]
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0
Phase 2 and Phase 3
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Timepoint [34]
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Up to 5 years
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Secondary outcome [35]
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Change from baseline in patient-reported general health status per EuroQoL-5 Dimensions, 5-level Questionnaire-Visual Analogue Score (EQ-5D-5L VAS)
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Assessment method [35]
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Phase 2 and Phase 3 The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine".
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Timepoint [35]
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Up to 5 years
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Secondary outcome [36]
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Change from baseline in patient-reported severity with usual or daily activities due to fatigue per the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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Assessment method [36]
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Phase 2 and Phase 3 PRO-CTCAE questionnaire assesses side effect symptoms in cancer clinical trials using a PRO-CTCAE score. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
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Timepoint [36]
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Up to 5 years
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Secondary outcome [37]
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Change from baseline in patient-reported interference with usual or daily activities due to fatigue per the Patient Reported Outcomes for Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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Assessment method [37]
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Phase 2 and Phase 3
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Timepoint [37]
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Up to 5 years
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Secondary outcome [38]
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Concentrations of cemiplimab in serum
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Assessment method [38]
0
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Phase 2 and Phase 3
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Timepoint [38]
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Up to 136 weeks
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Secondary outcome [39]
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Concentrations of fianlimab in serum
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Assessment method [39]
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Phase 2 and Phase 3
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Timepoint [39]
0
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Up to 136 weeks
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Secondary outcome [40]
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Immunogenicity, as measured by anti-drug antibodies (ADA) to fianlimab
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Assessment method [40]
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0
Phase 2 and Phase 3
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Timepoint [40]
0
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Up to 136 weeks
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Secondary outcome [41]
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Immunogenicity, as measured by ADA to cemiplimab
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Assessment method [41]
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0
Phase 2 and Phase 3
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Timepoint [41]
0
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Up to 136 weeks
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Secondary outcome [42]
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Immunogenicity, as measured by neutralizing antibodies (NAb) to fianlimab
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Assessment method [42]
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0
Phase 2 and Phase 3
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Timepoint [42]
0
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Up to 136 weeks
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Secondary outcome [43]
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Immunogenicity, as measured by NAb to cemiplimab
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Assessment method [43]
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Phase 2 and Phase 3
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Timepoint [43]
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Up to 136 weeks
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Eligibility
Key inclusion criteria
Key
1. Patients with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic disease), who received no prior systemic treatment for recurrent or metastatic NSCLC.
2. Availability of an archival or on-study formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample, without intervening therapy between biopsy collection and screening as described in the protocol
3. For enrollment in phase 2, patients should have PD-L1 levels = 50%, as determined by a College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) (or equivalently licensed, according to local regulations) accredited laboratory, as described in the protocol. For enrollment in phase 3, patients should have expression of programmed cell death ligand-1 (PD-L1) in =50% of tumor cells stained using an assay performed by a central laboratory, as described in the protocol.
4. At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site.
5. Eastern Cooperative Oncology Group (ECOG) performance status of =1.
6. Adequate organ and bone marrow function, as described in the protocol.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patients who have never smoked, defined as smoking =100 cigarettes in a lifetime.
2. Active or untreated brain metastases or spinal cord compression. Patients are eligible if central nervous system (CNS) metastases are adequately treated, and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. Patients must be off (immunosuppressive doses of) corticosteroid therapy.
3. Patients with tumors tested positive for actionable epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions, as described in the protocol.
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. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved =6 months prior to enrollment.
6. Known primary immunodeficiencies, either cellular (eg, DiGeorge syndrome, T-cell-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (eg, T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
7. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-mediated treatment-emergent adverse events (imTEAEs). Patients with uncontrolled type 1 diabetes mellitus or with uncontrolled adrenal insufficiency are excluded. The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.
8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization. Physiologic replacement doses are allowed even if they are >10 mg of prednisone/day or equivalent, as long as they are not being administered for immunosuppressive intent. Patients with clinically relevant systemic immune suppression within the last 3 months before trial enrollment are excluded. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.
9. Patients who have received prior systemic therapies are excluded with the exception of the following:
1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy as long as toxicities have resolved to CTCAE grade =1 or baseline with the exception of alopecia and peripheral neuropathy.
2. Anti-PD-(L) 1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is >12 months prior to enrollment.
3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or neoadjuvant therapy, Cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibodies as long as the last dose is >6 months prior to enrollment. Immune-mediated AEs must be resolved to CTCAE grade =1 or baseline by the time of enrollment. Endocrine immune-mediated AEs controlled with hormonal or other non-immunosuppressive therapies without resolution prior to enrollment are allowed.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/02/2032
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Actual
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Sample size
Target
850
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Macquarie University Health Science Center (MQ Health) - Macquarie Park
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Recruitment hospital [2]
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Riverina Cancer Care Centre (RCCC) - Wagga Wagga
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Recruitment hospital [3]
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Southern Medical Day Care Centre - Wollongong
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Recruitment hospital [4]
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Ballarat Regional Integrated Cancer Centre (BRICC) - Ballarat
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Recruitment hospital [5]
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Bendigo Hospital - Bendigo
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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Recruitment postcode(s) [2]
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2650 - Wagga Wagga
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Recruitment postcode(s) [3]
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NSW 2500 - Wollongong
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Recruitment postcode(s) [4]
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3350 - Ballarat
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Recruitment postcode(s) [5]
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3550 - Bendigo
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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0
United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Louisiana
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Country [5]
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United States of America
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0
Mississippi
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United States of America
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State/province [6]
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New Jersey
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United States of America
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State/province [7]
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Tennessee
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0
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United States of America
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State/province [11]
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Virginia
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Country [12]
0
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Canada
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State/province [12]
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British Columbia
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Country [13]
0
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Georgia
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State/province [13]
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Adjaria
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Country [14]
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Georgia
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State/province [14]
0
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Tbilisi
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Country [15]
0
0
Israel
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State/province [15]
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HaDarom
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Country [16]
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Israel
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State/province [16]
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Jerusalem
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Country [17]
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Israel
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State/province [17]
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Tel Aviv
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Country [18]
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Korea, Republic of
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State/province [18]
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Chungbuk
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Country [19]
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Korea, Republic of
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State/province [19]
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Gyeonggi
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Korea, Republic of
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State/province [20]
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Jeollabuk-do
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Country [21]
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Korea, Republic of
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State/province [21]
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Daejeon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Korea, Republic of
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Ulsan
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Malaysia
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Johor
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Malaysia
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Pahang
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Malaysia
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Wilayah Persekutuan
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Malaysia
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WP
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Malaysia
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Pulau Pinang
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Taiwan
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State/province [31]
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Hualien City
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Taiwan
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State/province [32]
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Kaohsiung
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Taiwan
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State/province [33]
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New Taipei City
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Taiwan
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State/province [34]
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Taipei
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Thailand
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Lampang
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Turkey
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Meram
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Turkey
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Samsun
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Turkey
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Ankara
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Regeneron Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a "study drug" or collectively called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much study drug is in your blood at different times * Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects) * How administering the study drugs might improve your quality of life
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Trial website
https://clinicaltrials.gov/study/NCT05785767
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Trial Management
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Regeneron Pharmaceuticals
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Contact person for public queries
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Clinical Trials Administrator
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Phone
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844-734-6643
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
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Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05785767