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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

27/11/2024

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]

2023-505172-29-00

Secondary ID [2]

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

Condition category

Condition code

Cancer

Lung - Mesothelioma

Cancer

Lung - Non small cell

Cancer

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples

Timepoint [1]

Up to 24 months

Secondary outcome [1]

Event-Free Survival (EFS)

Timepoint [1]

Up to 3 years

Secondary outcome [2]

Major pathological response (MPR) by BIPR in post-treatment resected tumor samples

Timepoint [2]

Up to 24 months

Secondary outcome [3]

MPR by local pathology review in post-treatment resected tumor samples

Timepoint [3]

Up to 24 months

Secondary outcome [4]

Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

Timepoint [4]

Up to 24 months

Secondary outcome [5]

Occurrence of Adverse events (AEs)

Timepoint [5]

Up to 5 years

Secondary outcome [6]

Occurrence of Treatment-emergent adverse event (TEAEs)

Timepoint [6]

Up to 5 years

Secondary outcome [7]

Occurrence of Serious adverse events (SAEs)

Timepoint [7]

Up to 5 years

Secondary outcome [8]

Occurrence of Adverse events of special interest (AESIs)

Timepoint [8]

Up to 5 years

Secondary outcome [9]

Occurrence of immune-mediated adverse events (imAEs)

Timepoint [9]

Up to 5 years

Secondary outcome [10]

Occurrence of interruption and discontinuation of study drug(s) due to TEAE

Timepoint [10]

Up to 5 years

Secondary outcome [11]

Occurrence of laboratory abnormalities

Timepoint [11]

Up to 5 years

Secondary outcome [12]

Occurrence of death due to TEAE

Timepoint [12]

Up to 5 years

Secondary outcome [13]

Concentrations of cemiplimab in serum

Timepoint [13]

Up to 30 months

Secondary outcome [14]

Concentrations of fianlimab in serum

Timepoint [14]

Up to 30 months

Secondary outcome [15]

Anti-drug antibodies (ADA) to fianlimab in serum over time

Timepoint [15]

Up to 30 months

Secondary outcome [16]

ADA to cemiplimab in serum over time

Timepoint [16]

Up to 30 months

Secondary outcome [17]

Percentage of patients with definitive surgery

Timepoint [17]

Up to 24 months

Secondary outcome [18]

Percentage of patients with cancelled surgery

Timepoint [18]

Up to 24 months

Secondary outcome [19]

Percentage of patients with delayed surgery

Timepoint [19]

Up to 24 months

Secondary outcome [20]

Completeness of resection (R0, R1, R2, Rx)

Timepoint [20]

Up to 24 months

Secondary outcome [21]

Length in delay of surgery

Timepoint [21]

Up to 24 months

Secondary outcome [22]

Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)

Timepoint [22]

Up to 24 months

Secondary outcome [23]

Median length of hospital stay

Timepoint [23]

Up to 24 months

Secondary outcome [24]

Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)

Timepoint [24]

Up to 24 months

Secondary outcome [25]

Incidence of peri operative AE associated with surgery

Timepoint [25]

Up to 90 days post-surgery

Secondary outcome [26]

Incidence of peri operative SAE associated with surgery

Timepoint [26]

Up to 90 days post-surgery

Secondary outcome [27]

Incidence of post operative AE associated with surgery

Timepoint [27]

Up to 90 days post-surgery

Secondary outcome [28]

Incidence of post operative SAE associated with surgery

Timepoint [28]

Up to 90 days post-surgery

Secondary outcome [29]

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]

Up to 5 years

Secondary outcome [30]

Overall change in patient-reported physical functioning per EORTC QLQ-C30

Timepoint [30]

Up to 5 years

Secondary outcome [31]

Overall change in patient-reported role functioning per EORTC QLQ-C30

Timepoint [31]

Up to 5 years

Secondary outcome [32]

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]

Up to 5 years

Secondary outcome [33]

Overall change in patient-reported dyspnea per EORTC QLQ-LC13

Timepoint [33]

Up to 5 years

Secondary outcome [34]

Overall change in patient-reported cough per EORTC QLQ-LC13

Timepoint [34]

Up to 5 years

Secondary outcome [35]

Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13

Timepoint [35]

Up to 5 years

Secondary outcome [36]

Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index

Timepoint [36]

Up to 5 years

Secondary outcome [37]

Change in patient-reported general health status per Visual analogue scale (VAS) scores

Timepoint [37]

Up to 5 years

Secondary outcome [38]

Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

Timepoint [38]

Up to 5 years

Secondary outcome [39]

Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30

Timepoint [39]

Up to 5 years

Secondary outcome [40]

Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30

Timepoint [40]

Up to 5 years

Secondary outcome [41]

Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13

Timepoint [41]

Up to 5 years

Secondary outcome [42]

Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13

Timepoint [42]

Up to 5 years

Secondary outcome [43]

Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13

Timepoint [43]

Up to 5 years

Secondary outcome [44]

Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13

Timepoint [44]

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?

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]

Eastern Health - Box Hill

Recruitment hospital [2]

St Vincents Hospital - Fitzroy

Recruitment hospital [3]

St John of God Murdoch Hospital - Murdoch

Recruitment postcode(s) [1]

3128 - Box Hill

Recruitment postcode(s) [2]

3065 - Fitzroy

Recruitment postcode(s) [3]

6150 - Murdoch

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Florida

Country [2]

United States of America

State/province [2]

Illinois

Country [3]

United States of America

State/province [3]

Michigan

Country [4]

United States of America

State/province [4]

New Jersey

Country [5]

United States of America

State/province [5]

New York

Country [6]

United States of America

State/province [6]

Oregon

Country [7]

United States of America

State/province [7]

Virginia

Country [8]

Chile

State/province [8]

Metropolitan Region

Country [9]

Chile

State/province [9]

Providencia

Country [10]

Chile

State/province [10]

Valparaiso

Country [11]

Georgia

State/province [11]

Caucasus

Country [12]

Georgia

State/province [12]

Batumi

Country [13]

Georgia

State/province [13]

Tbilisi

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Regeneron Pharmaceuticals

Address

Country

Ethics approval

Ethics application status

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

Trial website

https://clinicaltrials.gov/study/NCT06161441

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Trial Management

Address

Regeneron Pharmaceuticals

Country

Phone

Fax

Contact person for public queries

Name

Clinical Trials Administrator

Address

Country

Phone

844-734-6643

Fax

[email protected]

Contact person for scientific queries

Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06161441

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06161441