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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06161441
Registration number
NCT06161441
Ethics application status
Date submitted
29/11/2023
Date registered
7/12/2023
Date last updated
24/06/2025
Titles & IDs
Public title
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
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Scientific title
A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC
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Secondary ID [1]
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2023-505172-29-00
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Secondary ID [2]
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R3767-ONC-2266
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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:
Resectable 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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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 - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Placebo
Experimental: Arm A - Randomized 1:1:1
Neoadjuvant period:
placebo + cemiplimab + platinum doublet chemotherapy
Adjuvant period:
placebo + cemiplimab
Experimental: Arm B - Randomized 1:1:1
Neoadjuvant period:
fianlimab high dose + cemiplimab + platinum doublet chemotherapy
Adjuvant period:
fianlimab high dose + cemiplimab
Experimental: Arm C - Randomized 1:1:1
Neoadjuvant period:
fianlimab low dose + cemiplimab + platinum doublet chemotherapy
Adjuvant Period:
fianlimab low dose + cemiplimab
Treatment: Drugs: Fianlimab
Administered intravenously (IV) every 3 weeks (Q3W)
Treatment: Drugs: Cemiplimab
Administered IV Q3W
Treatment: Drugs: Pemetrexed
Administered IV Q3W
Treatment: Drugs: Paclitaxel
Administered IV Q3W
Treatment: Drugs: Carboplatin
Administered IV Q3W
Treatment: Drugs: Cisplatin
Administered IV Q3W
Treatment: Drugs: Placebo
Administered IV Q3W
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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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Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples
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Assessment method [1]
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Timepoint [1]
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Up to 24 months
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Secondary outcome [1]
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Event-Free Survival (EFS)
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Assessment method [1]
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Major pathological response (MPR) by BIPR in post-treatment resected tumor samples
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Assessment method [2]
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Timepoint [2]
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Up to 24 months
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Secondary outcome [3]
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MPR by local pathology review in post-treatment resected tumor samples
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Assessment method [3]
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Timepoint [3]
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Up to 24 months
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Secondary outcome [4]
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Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
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Assessment method [4]
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0
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Timepoint [4]
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Up to 24 months
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Secondary outcome [5]
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Occurrence of Adverse events (AEs)
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Assessment method [5]
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0
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Occurrence of Treatment-emergent adverse event (TEAEs)
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Assessment method [6]
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Occurrence of Serious adverse events (SAEs)
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Assessment method [7]
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Occurrence of Adverse events of special interest (AESIs)
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Assessment method [8]
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0
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Occurrence of immune-mediated adverse events (imAEs)
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Assessment method [9]
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0
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Timepoint [9]
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Up to 5 years
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Secondary outcome [10]
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Occurrence of interruption and discontinuation of study drug(s) due to TEAE
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Assessment method [10]
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0
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Occurrence of laboratory abnormalities
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Assessment method [11]
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Grade =3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests
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Timepoint [11]
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Up to 5 years
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Secondary outcome [12]
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0
Occurrence of death due to TEAE
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Assessment method [12]
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0
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Timepoint [12]
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Up to 5 years
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Secondary outcome [13]
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Concentrations of cemiplimab in serum
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Assessment method [13]
0
0
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Timepoint [13]
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Up to 30 months
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Secondary outcome [14]
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Concentrations of fianlimab in serum
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Assessment method [14]
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0
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Timepoint [14]
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Up to 30 months
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Secondary outcome [15]
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Anti-drug antibodies (ADA) to fianlimab in serum over time
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Assessment method [15]
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0
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Timepoint [15]
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Up to 30 months
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Secondary outcome [16]
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ADA to cemiplimab in serum over time
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Assessment method [16]
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Timepoint [16]
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Up to 30 months
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Secondary outcome [17]
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Percentage of patients with definitive surgery
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Assessment method [17]
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Timepoint [17]
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Up to 24 months
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Secondary outcome [18]
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Percentage of patients with cancelled surgery
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Assessment method [18]
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Timepoint [18]
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Up to 24 months
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Secondary outcome [19]
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Percentage of patients with delayed surgery
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Assessment method [19]
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Timepoint [19]
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Up to 24 months
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Secondary outcome [20]
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Completeness of resection (R0, R1, R2, Rx)
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Assessment method [20]
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0
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Timepoint [20]
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Up to 24 months
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Secondary outcome [21]
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Length in delay of surgery
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Assessment method [21]
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Timepoint [21]
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Up to 24 months
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Secondary outcome [22]
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Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)
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Assessment method [22]
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Timepoint [22]
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Up to 24 months
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Secondary outcome [23]
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Median length of hospital stay
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Assessment method [23]
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Timepoint [23]
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Up to 24 months
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Secondary outcome [24]
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Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)
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Assessment method [24]
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Timepoint [24]
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Up to 24 months
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Secondary outcome [25]
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Incidence of peri operative AE associated with surgery
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Assessment method [25]
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Timepoint [25]
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Up to 90 days post-surgery
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Secondary outcome [26]
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Incidence of peri operative SAE associated with surgery
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Assessment method [26]
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Timepoint [26]
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Up to 90 days post-surgery
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Secondary outcome [27]
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Incidence of post operative AE associated with surgery
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Assessment method [27]
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Timepoint [27]
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Up to 90 days post-surgery
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Secondary outcome [28]
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Incidence of post operative SAE associated with surgery
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Assessment method [28]
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0
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Timepoint [28]
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Up to 90 days post-surgery
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Secondary outcome [29]
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Overall change in patient-reported global health status/QoL per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
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Assessment method [29]
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EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (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 [29]
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Up to 5 years
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Secondary outcome [30]
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Overall change in patient-reported physical functioning per EORTC QLQ-C30
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Assessment method [30]
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0
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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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Overall change in patient-reported role functioning per EORTC QLQ-C30
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Assessment method [31]
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0
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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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Overall change in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
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Assessment method [32]
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The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
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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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Overall change in patient-reported dyspnea per EORTC QLQ-LC13
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Assessment method [33]
0
0
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Timepoint [33]
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Up to 5 years
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Secondary outcome [34]
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Overall change in patient-reported cough per EORTC QLQ-LC13
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Assessment method [34]
0
0
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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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Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13
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Assessment method [35]
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0
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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 in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index
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Assessment method [36]
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The EQ-5D-5L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: no problems, slight problems, moderate problems, severe problems and extreme problems
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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 in patient-reported general health status per Visual analogue scale (VAS) scores
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Assessment method [37]
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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 [37]
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Up to 5 years
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Secondary outcome [38]
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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 [38]
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0
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Timepoint [38]
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Up to 5 years
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Secondary outcome [39]
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Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30
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Assessment method [39]
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0
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Timepoint [39]
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Up to 5 years
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Secondary outcome [40]
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Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30
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Assessment method [40]
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0
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Timepoint [40]
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Up to 5 years
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Secondary outcome [41]
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Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13
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Assessment method [41]
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0
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Timepoint [41]
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Up to 5 years
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Secondary outcome [42]
0
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Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13
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Assessment method [42]
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0
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Timepoint [42]
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Up to 5 years
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Secondary outcome [43]
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Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13
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Assessment method [43]
0
0
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Timepoint [43]
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Up to 5 years
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Secondary outcome [44]
0
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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 [44]
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0
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Timepoint [44]
0
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
1. Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
2. For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
3. All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
4. A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate bone marrow, hepatic and kidney function as defined 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. Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
2. Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
4. Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
5. Patients with a history of myocarditis
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
16/07/2024
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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
19/04/2029
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Eastern Health - Box Hill
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Recruitment hospital [2]
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St Vincents Hospital - Fitzroy
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Recruitment hospital [3]
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St John of God Murdoch Hospital - Murdoch
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
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Florida
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0
0
United States of America
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State/province [3]
0
0
Illinois
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0
0
United States of America
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0
0
Kansas
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Michigan
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Country [6]
0
0
United States of America
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State/province [6]
0
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Missouri
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Country [7]
0
0
United States of America
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0
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New Jersey
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Country [8]
0
0
United States of America
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State/province [8]
0
0
New York
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Oregon
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Country [10]
0
0
United States of America
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0
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Virginia
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0
0
Chile
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State/province [11]
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Metropolitan Region
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Country [12]
0
0
Chile
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State/province [12]
0
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Providencia
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Country [13]
0
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Chile
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State/province [13]
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Region Metropolitana, Santiago
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0
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Chile
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State/province [14]
0
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Valparaiso
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Country [15]
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France
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State/province [15]
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Grand Est
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Country [16]
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France
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State/province [16]
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Ile De France
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Country [17]
0
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France
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State/province [17]
0
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Nantes
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Country [18]
0
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France
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State/province [18]
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Nouvelle Aquitaine
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Country [19]
0
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France
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Vantoux
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France
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Boulogne-Billancourt
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France
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Dijon
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0
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Georgia
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Caucasus
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Georgia
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Batumi
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Georgia
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Tbilisi
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Germany
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North Rhine Westphalia
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Germany
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Schleswig-Holstein
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Germany
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Hamburg
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Country [28]
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Germany
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State/province [28]
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Neuss
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Country [29]
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Italy
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Emilia Romagna
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Italy
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Emilia-Romagna
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Italy
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Lombardy
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Italy
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State/province [32]
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Pesaro And Urbino
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Italy
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Piedmont
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Italy
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Pordenone
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Italy
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Turin
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Italy
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Livorno
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Italy
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Milano
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Italy
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Novara
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Italy
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Pavia
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Italy
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Roma
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Italy
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Rome
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Malaysia
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Negeri / Wilayah Persekutuan
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Malaysia
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Pulau Pinang
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Malaysia
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Wilayah Persekutuan
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Malaysia
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Kuching
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Romania
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Bucuresti
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Romania
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Cluj
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Romania
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0
Timis
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0
Romania
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Bucharest
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Spain
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A Coruna
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Spain
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Catalonia
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Spain
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Catalunya
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Navarra
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Spain
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Pontevedra
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Spain
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Barcelona
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Girona
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Lugo
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Sevilla
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Spain
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Valencia
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Taiwan
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Changhua County
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Taiwan
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Sanmin
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Taiwan
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Hualien City
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Taiwan
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New Taipei City
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Turkey
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Marmara
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Turkey
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Meram
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Ankara
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Funding & Sponsors
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Commercial sector/industry
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Name
Regeneron Pharmaceuticals
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Summary
Brief summary
This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery. The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life
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Trial website
https://clinicaltrials.gov/study/NCT06161441
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Contacts
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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
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[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06161441
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