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)

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465329
• Other study ID #: R2810-ONC-2268
• Secondary ID: 2023-509806-31-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2024
• Est. completion date: May 21, 2030

Study information

• Verified date: June 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 21, 2030
• Est. primary completion date: June 22, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Cemiplimab
Intravenous (IV) infusion administration
• Platinum-based chemotherapy
IV infusion
• REGN7075
IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)		Up to 12 weeks
Secondary	Pathologic complete response (pCR) rate as determined by central BIPR		Up to 12 weeks
Secondary	Residual viable tumor (RVT) as determined by central BIPR		Up to 12 weeks
Secondary	Median event-free survival (EFS)		Up to 3 years
Secondary	EFS rate		Up to 3 years
Secondary	Objective response rate (ORR)		Up to 9 weeks
Secondary	Overall survival (OS)		Up to 3 years
Secondary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 76 weeks
Secondary	Severity of TEAEs		Up to 76 weeks
Secondary	Incidence of TEAEs leading to death		Up to 76 weeks
Secondary	Incidence of TEAEs leading to treatment discontinuation		Up to 76 weeks
Secondary	Incidence of serious adverse events (SAEs)		Up to 76 weeks
Secondary	Incidence of adverse events of special interest (AESIs)		Up to 76 weeks
Secondary	Incidence of immune-mediated adverse events (imAEs)		Up to 76 weeks
Secondary	Incidence of infusion-related reactions (IRRs)		Up to 76 weeks
Secondary	Incidence of grade =3 laboratory abnormalities	As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades)	Up to 76 weeks
Secondary	Proportion of delayed surgeries due to TEAEs		Up to 76 weeks
Secondary	Proportion of cancelled surgeries due to TEAEs		Up to 76 weeks
Secondary	Incidence of anti-drug antibodies (ADAs) to cemiplimab over time		Up to 67 weeks
Secondary	Titer of ADAs to cemiplimab over time		Up to 67 weeks
Secondary	Incidence of ADAs to novel anti-cancer agents over time		Up to 67 weeks
Secondary	Titer of ADAs to novel anti-cancer agents over time		Up to 67 weeks