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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

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
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
Secondary ID [1] 0 0
2023-505172-29-00
Secondary ID [2] 0 0
R3767-ONC-2266
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resectable Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Event-Free Survival (EFS)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Major pathological response (MPR) by BIPR in post-treatment resected tumor samples
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
MPR by local pathology review in post-treatment resected tumor samples
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Occurrence of Adverse events (AEs)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Occurrence of Treatment-emergent adverse event (TEAEs)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Occurrence of Serious adverse events (SAEs)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Occurrence of Adverse events of special interest (AESIs)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Occurrence of immune-mediated adverse events (imAEs)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Occurrence of interruption and discontinuation of study drug(s) due to TEAE
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Occurrence of laboratory abnormalities
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Occurrence of death due to TEAE
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Concentrations of cemiplimab in serum
Timepoint [13] 0 0
Up to 30 months
Secondary outcome [14] 0 0
Concentrations of fianlimab in serum
Timepoint [14] 0 0
Up to 30 months
Secondary outcome [15] 0 0
Anti-drug antibodies (ADA) to fianlimab in serum over time
Timepoint [15] 0 0
Up to 30 months
Secondary outcome [16] 0 0
ADA to cemiplimab in serum over time
Timepoint [16] 0 0
Up to 30 months
Secondary outcome [17] 0 0
Percentage of patients with definitive surgery
Timepoint [17] 0 0
Up to 24 months
Secondary outcome [18] 0 0
Percentage of patients with cancelled surgery
Timepoint [18] 0 0
Up to 24 months
Secondary outcome [19] 0 0
Percentage of patients with delayed surgery
Timepoint [19] 0 0
Up to 24 months
Secondary outcome [20] 0 0
Completeness of resection (R0, R1, R2, Rx)
Timepoint [20] 0 0
Up to 24 months
Secondary outcome [21] 0 0
Length in delay of surgery
Timepoint [21] 0 0
Up to 24 months
Secondary outcome [22] 0 0
Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)
Timepoint [22] 0 0
Up to 24 months
Secondary outcome [23] 0 0
Median length of hospital stay
Timepoint [23] 0 0
Up to 24 months
Secondary outcome [24] 0 0
Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)
Timepoint [24] 0 0
Up to 24 months
Secondary outcome [25] 0 0
Incidence of peri operative AE associated with surgery
Timepoint [25] 0 0
Up to 90 days post-surgery
Secondary outcome [26] 0 0
Incidence of peri operative SAE associated with surgery
Timepoint [26] 0 0
Up to 90 days post-surgery
Secondary outcome [27] 0 0
Incidence of post operative AE associated with surgery
Timepoint [27] 0 0
Up to 90 days post-surgery
Secondary outcome [28] 0 0
Incidence of post operative SAE associated with surgery
Timepoint [28] 0 0
Up to 90 days post-surgery
Secondary outcome [29] 0 0
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)
Timepoint [29] 0 0
Up to 5 years
Secondary outcome [30] 0 0
Overall change in patient-reported physical functioning per EORTC QLQ-C30
Timepoint [30] 0 0
Up to 5 years
Secondary outcome [31] 0 0
Overall change in patient-reported role functioning per EORTC QLQ-C30
Timepoint [31] 0 0
Up to 5 years
Secondary outcome [32] 0 0
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)
Timepoint [32] 0 0
Up to 5 years
Secondary outcome [33] 0 0
Overall change in patient-reported dyspnea per EORTC QLQ-LC13
Timepoint [33] 0 0
Up to 5 years
Secondary outcome [34] 0 0
Overall change in patient-reported cough per EORTC QLQ-LC13
Timepoint [34] 0 0
Up to 5 years
Secondary outcome [35] 0 0
Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13
Timepoint [35] 0 0
Up to 5 years
Secondary outcome [36] 0 0
Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index
Timepoint [36] 0 0
Up to 5 years
Secondary outcome [37] 0 0
Change in patient-reported general health status per Visual analogue scale (VAS) scores
Timepoint [37] 0 0
Up to 5 years
Secondary outcome [38] 0 0
Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
Timepoint [38] 0 0
Up to 5 years
Secondary outcome [39] 0 0
Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30
Timepoint [39] 0 0
Up to 5 years
Secondary outcome [40] 0 0
Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30
Timepoint [40] 0 0
Up to 5 years
Secondary outcome [41] 0 0
Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13
Timepoint [41] 0 0
Up to 5 years
Secondary outcome [42] 0 0
Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13
Timepoint [42] 0 0
Up to 5 years
Secondary outcome [43] 0 0
Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13
Timepoint [43] 0 0
Up to 5 years
Secondary outcome [44] 0 0
Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13
Timepoint [44] 0 0
Up to 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/04/2029
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Eastern Health - Box Hill
Recruitment hospital [2] 0 0
St Vincents Hospital - Fitzroy
Recruitment hospital [3] 0 0
St John of God Murdoch Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Chile
State/province [8] 0 0
Metropolitan Region
Country [9] 0 0
Chile
State/province [9] 0 0
Providencia
Country [10] 0 0
Chile
State/province [10] 0 0
Valparaiso
Country [11] 0 0
Georgia
State/province [11] 0 0
Caucasus
Country [12] 0 0
Georgia
State/province [12] 0 0
Batumi
Country [13] 0 0
Georgia
State/province [13] 0 0
Tbilisi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
clinicaltrials@regeneron.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
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 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.
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
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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