Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
Phase II Single Arm Study of Neoadjuvant Dual Checkpoint Blockade With Programmed Death-ligand 1 (PD1) and Lymphocyte Activation Gene 3 (LAG-3) Inhibition in Resectable Non-Small Cell Lung Cancer (N-PLANC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Blood draws, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients undergo magnetic resonance imaging (MRI) during screening, tissue sample collection on study and blood sample collection on study and follow-up."
- "After completion of study treatment, patients are followed up at 90 days, then every 3 months post-surgery for the first 2 years, then every 6 months for up to 5 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests cemiplimab and fianlimab together at set doses before surgery. These drugs may help the immune system attack cancer. It is for adults with stage IB–IIIB non-small cell lung cancer that can be fully removed by surgery.
This phase II trial tests how well a fixed dose combination (FDC) of cemiplimab and fianlimab before surgery (neoadjuvant) works in treating patients with stage IB-IIIB non-small cell lung cancer (NSCLC). The current standard of care (SOC) for NSCLC is to give chemotherapy and immunotherapy before going to surgery to have the cancer removed (neoadjuvant therapy). Immunotherapy with monoclonal antibodies, such as cemiplimab and fianlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a FDC of cemiplimab and fianlimab before surgery may kill more tumor cells in treating patients with stage IB-IIIB NSCLC.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have stage IB–IIIB (N2) non-small cell lung cancer confirmed by a tissue or cell test. T4 tumors qualify only if their size—over 7 cm—is the only reason for that rating.
- Have cancer that a chest surgeon believes can be fully removed. Suspicious or enlarged lymph nodes must be checked for cancer and discussed with the study team.
- Have PD-L1, a protein, on at least 1% of tumor cells. Have cancer that can be measured by scans, not only by a physical exam or in a previously treated radiation area.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Meet the study’s lung function, blood count, liver, kidney, and blood-clotting test requirements.
- Have a negative pregnancy test within 8 days before signing up, if able to become pregnant.
- Sign a consent form, agree to give blood and tumor tissue samples for research, and return to the study center for follow-up.
Who can't join
- Be pregnant or breastfeeding, or be able to become pregnant or father a child but unwilling to use highly effective birth control during treatment and for 6 months after the last dose.
- Have cancer that cannot be removed by surgery, has spread to distant sites, or has certain EGFR, ALK, or ROS1 gene changes that drugs can target.
- Have already received whole-body cancer treatment or radiation for this cancer, or be receiving another study drug to treat it.
- Have certain lung scarring or inflammation, an autoimmune disease (when the immune system attacks the body), or a condition needing drugs that weaken the immune system. Some exceptions apply. Recent use of these drugs or higher-dose steroids may also rule you out.
- Have had an organ transplant, a heart attack within 6 months, prior immune-related heart inflammation, or certain serious heart problems.
- Have an uncontrolled infection or other serious illness, breathing trouble at rest needing constant oxygen, or mental health or social problems that prevent following study requirements. Controlled HIV or hepatitis B or C may be allowed with specialist care.
- Have another cancer or serious disease that could affect study safety or results, or a known allergy to either study drug or its ingredients.
- Have received a live vaccine within 30 days before signing up.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
MN
- Mayo Clinic in Rochester · Rochester, MN 55905Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduKaushal Parikh, MBBS · Principal investigatorMore trials in Rochester