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)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Cemiplimab; Drug: REGN7075; Drug: Platinum-based chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06465329

2023-509806-31-00 (Registry Identifier)

R2810-ONC-2268

Details and patient eligibility

About

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)?

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Chemotherapy+Cemiplimab

Active Comparator group

Description:

Control treatment

Treatment:

Drug: Platinum-based chemotherapy

Drug: Cemiplimab

Arm 1: Chemotherapy+Cemiplimab+REGN7075

Experimental group

Description:

Investigational Treatment

Treatment:

Drug: Platinum-based chemotherapy

Drug: REGN7075

Drug: Cemiplimab