Immune drugs given before surgery show promise against multiple cancers
NCT ID NCT03916627
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study is testing whether giving the immune-boosting drug cemiplimab (alone or with other drugs) before surgery can shrink tumors in people with non-small cell lung cancer, liver cancer, or head and neck cancer. About 65 participants will receive treatment before their planned surgery. The main goal is to see how well the tumor responds and to check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cemiplimab (also known as Libtayo), sometimes combined with fianlimab or platinum chemotherapy
- What this could lead to
- If successful, this could show that giving these immune-boosting drugs before surgery helps shrink tumors and improve outcomes for people with these cancers.
- What could go wrong
- This is a small, early-phase study (65 people) across three cancer types, so results may not apply broadly. Side effects from immune activation can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
65 people
The number who actually took part.
- Started
-
Jul 2019
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Patient must have a known diagnosis of NSCLC, HCC, or HNSCC as defined in the protocol * Patient must be willing and able to provide blood samples at the indicated time points * Patient must be willing and able to have excisional or core needle biopsies of tumor prior to initiation of cemiplimab as defined in the protocol * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient is determined to be a surgical candidate for resection of their tumor * Adequate organ and bone marrow function as defined in the protocol Key Exclusion Criteria: * Patients who have had any systemic anti-cancer therapy or radiotherapy within 6 months prior to entering the study for their current tumor or a different primary tumor * Patients whose tumor burden, or pace of tumor growth, in the opinion of the Investigator will not permit delaying surgery * Patients who have participated in a study of an investigational agent or an investigational device within 4 weeks of study therapy or 5 half-lives (whichever is longer) * Patients who have had major surgery within 14 days prior to initiation of neoadjuvant Therapy * Patients with metastatic disease for whom the intent of surgery would not be curative * Uncontrolled, intercurrent illness as defined in the protocol and as determined by the Investigator * Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * Has active autoimmune disease that has required systemic treatment in the past 1 year * Has a known, additional malignancy that is progressing and/or requires active treatment. Exceptions include patients with: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy; in situ cervical or anal cancer; prostate cancer on stable dose of hormonal therapy without rising prostate-specific antigen (PSA); breast cancer who have been treated with curative intent, who may be on hormonal therapy. * Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent * History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to study treatment. * Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol * NSCLC cohorts only: Patients do not have a history of smoking. History of smoking is defined as smoking ≥100 cigarettes in a lifetime. * NSCLC cohorts only: Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or c-ros oncogene 1 (ROS1) fusions. Note: Other protocol defined Inclusion/Exclusion criteria apply
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Head and neck squamous cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- New antibody drug conjugate tested against advanced cancers
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- Two-Drug combo targets stubborn KRAS lung cancer
- New PET tracer aims to light up hidden cancer targets
- Smaller chest drain may speed recovery after lung cancer surgery