NCT06465329Active, not recruitingPhase 2
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
Regeneron Pharmaceuticals132 sites in 6 countries120 target enrollmentStarted: November 18, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 120
- Locations
- 132
- Primary Endpoint
- Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Study Overview
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 drug(s) (which could make the drug(s) less effective or could lead to side effects)?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General Key Inclusion Criteria:
- •Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
- •Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
- •Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
- •Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
- •Adequate organ and bone marrow function, as described in the protocol
- •General Key
Exclusion Criteria
- •Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
- •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
- •Presence of grade≥ 2 peripheral neuropathy
- •Another malignancy that is progressing or requires active treatment, as described in the protocol
- •Arm Specific Exclusion Criteria:
- •Grade ≥3 hypercalcemia, as defined in the protocol
- •Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
- •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.
Arms & Interventions
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Experimental
Investigational Treatment
Intervention: Platinum-based chemotherapy (Drug)
Chemotherapy+Cemiplimab
Active Comparator
Control treatment
Intervention: Cemiplimab (Drug)
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Experimental
Investigational Treatment
Intervention: REGN7075 (Drug)
Chemotherapy+Cemiplimab
Active Comparator
Control treatment
Intervention: Platinum-based chemotherapy (Drug)
Arm 1: Chemotherapy+Cemiplimab+REGN7075
Experimental
Investigational Treatment
Intervention: Cemiplimab (Drug)
Outcomes
Primary Outcomes
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Time Frame: Up to 12 weeks
Secondary Outcomes
- EFS rate(Up to 5 years)
- Median event-free survival (EFS)(Up to 5 years)
- Pathologic complete response (pCR) rate as determined by central BIPR(Up to 12 weeks)
- Residual viable tumor (RVT) as determined by central BIPR(Up to 12 weeks)
- Objective response rate (ORR)(Up to 9 weeks)
- Overall survival (OS)(Up to 5 years)
- Incidence of treatment-emergent adverse events (TEAEs)(Up to 76 weeks)
- Severity of TEAEs(Up to 76 weeks)
- Incidence of TEAEs leading to death(Up to 76 weeks)
- Incidence of TEAEs leading to treatment discontinuation(Up to 76 weeks)
- Incidence of serious adverse events (SAEs)(Up to 76 weeks)
- Incidence of adverse events of special interest (AESIs)(Up to 76 weeks)
- Incidence of immune-mediated adverse events (imAEs)(Up to 76 weeks)
- Incidence of infusion-related reactions (IRRs)(Up to 76 weeks)
- Incidence of grade ≥3 laboratory abnormalities(Up to 76 weeks)
- Proportion of delayed surgeries due to TEAEs(Up to 76 weeks)
- Proportion of cancelled surgeries due to TEAEs(Up to 76 weeks)
- Incidence of anti-drug antibodies (ADAs) to cemiplimab over time(Up to 67 weeks)
- Titer of ADAs to cemiplimab over time(Up to 67 weeks)
- Incidence of ADAs to novel anti-cancer agents over time(Up to 67 weeks)
- Titer of ADAs to novel anti-cancer agents over time(Up to 67 weeks)
Investigators
Study Sites (132)
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