New drug combo aims to shrink lung tumors before surgery
NCT ID NCT06918132
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing whether giving a combination of two immunotherapy drugs (cemiplimab and fianlimab) before surgery can kill more tumor cells in people with stage IB to IIIB non-small cell lung cancer. About 60 participants will receive the drugs intravenously, then undergo surgery to remove their cancer. The main goal is to see how many patients have a major pathologic response, meaning 10% or fewer viable tumor cells remain after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cemiplimab and fianlimab (immunotherapy drugs)
- What this could lead to
- If it works, this could offer a chemotherapy-free option before lung cancer surgery, potentially improving outcomes for patients with certain PD-L1 levels.
- What could go wrong
- This is a small, early-phase trial (60 participants) with no control group. The drugs may cause immune-related side effects, and results may not apply to all lung cancer patients.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Inclusion Criteria: * Age ≥ 18 years * Disease characteristics: * Histologically or cytologically confirmed stage IB-IIIB (N2) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition * T4 tumors will only be eligible if they are defined as T4 based only on their size (more than 7 cm). All other T4 tumors will be ineligible. * Pathologic status of lymph nodes must be known for suspicious or enlarged lymph nodes. Note: suspicious or enlarged lymph nodes must be discussed with sponsor/principal investigator. * PD-L1 expression ≥ 1% by tumor proportion score (TPS) using immunohistochemistry (IHC) * Group A: PD-L1 expression ≥ 1% \< 50% * Group B: PD-L1 expression ≥ 50% * Complete surgical resection of the primary NSCLC must be deemed achievable by thoracic surgeon at screening * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Adequate pulmonary function ascertained by treating surgeon obtained ≤ 30 days prior to registration. A pre- or post-bronchodilator forced expiratory volume in 1 second (FEV1) of 1.0 L or \> 40% postoperative predicted value or diffusing capacity of the lungs for carbon monoxide (DLCO) \> 40% predicted value are required prior to enrollment * Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained ≤ 15 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 15 days prior to registration) * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained ≤ 15 days prior to registration) * Calculated creatinine clearance ≥ 45 ml/min using the Cockroft-Gault formula (obtained ≤ 15 days prior to registration) * Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only * Provide written informed consent * Willingness to provide mandatory blood specimens for correlative research * Willingness to provide mandatory tissue specimens for correlative research * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown: * Pregnant persons * Nursing persons * Persons of childbearing potential or able to father a child who are unwilling to employ highly effective contraception during the study and up to 6 months after the last dose * Presence of targetable alterations \[Epiderman Growth Factor Receptor (EGFR), anaplastic lymphoma kinase (ALK), receptor tyrosine kinase (ROS1)\] in tumor * Unresectable or metastatic disease * Active or history of the following: * Prior systemic anti-cancer therapy or radiation therapy for the same cancer being studied in this protocol * Interstitial lung disease (e.g., idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or pneumonitis within the last 5 years * Autoimmune disease (including any history of inflammatory bowel disease) * Any syndrome that required systemic steroids or immunosuppressive medications EXCEPTIONS: patients with vitiligo; resolved childhood asthma/atopy; residual hypothyroidism that requires only hormone replacement; or psoriasis not requiring systemic treatment, type-1 diabetes mellitus, or rheumatoid arthritis managed without disease modifying anti-rheumatic drugs or \>10 mg prednisone equivalent * Patients requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days prior to registration. NOTE: Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease * Patients with organ transplantation * History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias; or prior immune-related myocarditis * Uncontrolled intercurrent non-cardiac illness including, but not limited to: * Ongoing or active infection * Psychiatric illness/social situations * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy * Any other conditions that would limit compliance with study requirements * Uncontrolled infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) or diagnosis of immunodeficiency that is related to, or results in chronic infection. Note: No testing is required for this study unless mandated by local health authority. EXCEPTIONS: * Patients with known HIV who have controlled infection \[undetectable viral load and cluster of differentiation 4 (CD4) count above 350 either spontaneously or on a stable antiviral regimen\] are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards. * Patients with known hepatitis B (hepatitis B surface antigen positive \[HBsAg+\]) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug. * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV ribonucleic acid (RNA) by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted. * Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial * Receiving any other investigational agent which would be considered as a treatment for the primary malignancy * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Patients with a prior or concurrent malignancy whose natural history or treatment does have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Known hypersensitivity to the active substances or to any of the excipients * Receipt of live vaccine ≤ 30 days prior to registration
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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