Non-Small Cell Lung Cancer
Conditions
Keywords
Lung Carcinoma, Resectable NSCLC
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)?
Interventions
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR) | Up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Median event-free survival (EFS) | Up to 5 years | — |
| EFS rate | Up to 5 years | — |
| 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 | As assessed by the Common Terminology Criteria for Adverse Events (CTCAE) grading system version 5.0 (for all grades) |
| 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 | — |
Countries
Brazil, France, Germany, Spain, Turkey (Türkiye), United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed