NCT06465329 · Regeneron Pharmaceuticals
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)
What this study is 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 experimental treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug.
View original scientific description
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.
Interventions
DRUG
Cemiplimab
Intravenous (IV) infusion administration
DRUG
Platinum-based chemotherapy
IV infusion
DRUG
REGN7075
IV infusion
Primary outcome measures
Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR)
Time frame: Up to 12 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 de
Where
- Orange, California
- Skokie, Illinois
- Detroit, Michigan
- Farmington Hills, Michigan
- Morristown, New Jersey
- New Brunswick, New Jersey
- Cincinnati, Ohio
- Portland, Oregon
- Providence, Rhode Island
- Watertown, South Dakota
- Knoxville, Tennessee
- Nashville, Tennessee
And 1 more location — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations