To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
NCT ID:
NCT06465329
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cemiplimab
Conditions: Keywords:
Lung Carcinoma
Resectable NSCLC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
Intravenous (IV) infusion administration
Arm group label:
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Arm group label:
Chemotherapy+Cemiplimab
Other name:
REGN2810
Other name:
LIBTAYO
Intervention type:
Drug
Intervention name:
Platinum-based chemotherapy
Description:
IV infusion
Arm group label:
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Arm group label:
Chemotherapy+Cemiplimab
Intervention type:
Drug
Intervention name:
REGN7075
Description:
IV infusion
Arm group label:
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Other name:
EGFRxCD28 bispecific immunotherapy
Summary:
This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell
lung cancer for whom surgery is planned.
The aim is to find out whether an investigational treatment (consisting of the
immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than
cemiplimab plus chemotherapy without the additional drug.
The study is also looking at several other research questions, including:
- What are the side effects associated with the investigational treatments in
comparison to the control treatment?
- Do the investigational treatments or the control treatment have an effect on the
type of surgery that is performed?
- How much of the study drug(s) are in the blood at a given time?
- Does the body make antibodies against the study drugs (which could make the drugs
less effective or could lead to side effects)?
Criteria for eligibility:
Criteria:
General Key Inclusion Criteria:
1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered
resectable with curative intent, as described in the protocol
2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
criteria version 1.1
3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for
submission, as described in the protocol
4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
5. Adequate organ and bone marrow function, as described in the protocol
General Key Exclusion Criteria:
1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described
in the protocol
2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR)
or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as
described in the protocol
3. Presence of ≥ grade 2 peripheral neuropathy
4. Another malignancy that is progressing or requires active treatment, as described in
the protocol
Arm Specific Exclusion Criteria:
Arm 1:
1. Grade ≥3 hypercalcemia, as defined in the protocol
2. Any central nervous system (CNS) pathology that could increase the risk of immune
effector cell-associated neurotoxicity syndrome (ICANS), as described in the
protocol
3. Has marked baseline prolongation of the time from the start of the Q wave to the end
of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk
factors for prolonged QTc, as described in the protocol
Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Orchard Healthcare Research Inc.
Address:
City:
Skokie
Zip:
60077
Country:
United States
Status:
Recruiting
Facility:
Name:
Detroit Clinical Research Center
Address:
City:
Farmington Hills
Zip:
48334
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Start date:
November 15, 2024
Completion date:
May 21, 2030
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465329
