Clinical trial NCT06465329: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung Carcinoma
Resectable NSCLC
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)?


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.

Primary outcomes:
measure: Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Pathologic complete response (pCR) rate as determined by central BIPR
timeFrame: Up to 12 weeks
measure: Residual viable tumor (RVT) as determined by central BIPR
timeFrame: Up to 12 weeks
measure: Median event-free survival (EFS)
timeFrame: Up to 3 years
measure: EFS rate
timeFrame: Up to 3 years
measure: Objective response rate (ORR)
timeFrame: Up to 9 weeks
measure: Overall survival (OS)
timeFrame: Up to 3 years
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 76 weeks
measure: Severity of TEAEs
timeFrame: Up to 76 weeks
measure: Incidence of TEAEs leading to death
timeFrame: Up to 76 weeks
measure: Incidence of TEAEs leading to treatment discontinuation
timeFrame: Up to 76 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 76 weeks
measure: Incidence of adverse events of special interest (AESIs)
timeFrame: Up to 76 weeks
measure: Incidence of immune-mediated adverse events (imAEs)
timeFrame: Up to 76 weeks
measure: Incidence of infusion-related reactions (IRRs)
timeFrame: Up to 76 weeks
measure: Incidence of grade ≥3 laboratory abnormalities
timeFrame: Up to 76 weeks
measure: Proportion of delayed surgeries due to TEAEs
timeFrame: Up to 76 weeks
measure: Proportion of cancelled surgeries due to TEAEs
timeFrame: Up to 76 weeks
measure: Incidence of anti-drug antibodies (ADAs) to cemiplimab over time
timeFrame: Up to 67 weeks
measure: Titer of ADAs to cemiplimab over time
timeFrame: Up to 67 weeks
measure: Incidence of ADAs to novel anti-cancer agents over time
timeFrame: Up to 67 weeks
measure: Titer of ADAs to novel anti-cancer agents over time
timeFrame: Up to 67 weeks
Other outcomes:
Locations:
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Watertown
country: United States
facility: Prairie Lakes Healthcare System
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Paris
country: France
facility: Institut Curie
state: Ile De France
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - CHITS
state: Var
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Montpellier
country: France
facility: Montpellier Academic Hospital
city: Rennes
country: France
facility: CHU Rennes
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH, Hauttumorzentrum
state: Hessen
city: Gottingen
country: Germany
facility: University Medicine Gottingen
state: Lower Saxony
city: Santander
country: Spain
facility: Hospital Valdecilla
state: Cantabria
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria
state: Las Palmas
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Seville
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Valencia
country: Spain
facility: Consorci Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: