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New treatment option for Non-small Cell Lung Cancer Stage III
Official title Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement
ClinicalTrials.gov ID: NCT06449313
What this study is testing
What is Cemiplimab-Rwlc?
Cemiplimab-Rwlc is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer stage iii.
Also referred to as Libtayo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years at time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed stage 3 B/C Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer...
- Primary tumor appropriate for resection with curative intent as assessed by the treating surgeon prior to study enrollment.
- Absence of major associated pathologies and co-morbidities that elevate surgery risk to a prohibitive level, as assessed by treating surgeon prior to...
- Pulmonary function capacity capable of tolerating the lung resection proposed by the treating surgeon.
You likely can't join if
- NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.
- Primary tumor not deemed appropriate for surgical resection as assessed by treating surgeon.
- Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.
- Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.
- Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.
- History of malignancy requiring systemic therapy within 2 years prior to screening, with the exception of malignancies with a negligible risk of...
See the full eligibility criteria
Who can join
- Age ≥ 18 years at time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed stage 3 B/C Non-Small Cell Lung Cancer (NSCLC) as assessed per the 8th American Joint Committee on Cancer (AJCC) with pathologically-confirmed contralateral mediastinal or...
- Primary tumor appropriate for resection with curative intent as assessed by the treating surgeon prior to study enrollment.
- Absence of major associated pathologies and co-morbidities that elevate surgery risk to a prohibitive level, as assessed by treating surgeon prior to study enrollment.
- Pulmonary function capacity capable of tolerating the lung resection proposed by the treating surgeon.
- EGFR, ALK, wild-type assessed via any CLIA-certified tissue testing platform. Documentation of EGFR and ALK status is not required for pure squamous NSCLC histology.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 21 days prior to initiation of study treatment:
- Absolute Neutrophil count (ANC) ≥ 1.0 x 10\^9/L (1000/uL) without granulocyte colony-stimulating factor support
- Platelet count ≥ 100 x 10\^9/L (100,000/uL) without transfusion
- Hemoglobin ≥ 90 g/L (9.0 g/dL) (Patients may be transfused to meet this criterion.)
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \</= 3 x upper limit of normal (ULN)
- Serum bilirubin \</= 2.0 x ULN with the following exception: Patients with known Gilbert disease: serum bilirubin \</= 3 x ULN
- Creatinine clearance ≥ 45 mL/min (calculated using the Cockcroft-Gault formula). If creatinine clearance determined by Cockcroft-Gault is \<45 mL/min, another appropriate validated formula or 24hr urine collection may...
- For patients not receiving therapeutic anticoagulation: INR (international normalised ratio) and aPTT (activated partial thromboplastin time) \</= 1.5 x ULN. For patients receiving therapeutic anticoagulation: stable...
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below: Women must remain...
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing...
What rules you out
- NSCLC with histology containing any of the following: large cell neuroendocrine carcinoma, small cell lung cancer.
- Primary tumor not deemed appropriate for surgical resection as assessed by treating surgeon.
- Tumor with direct invasion of: mediastinum, diaphragm, heart, great vessels, trachea, esophagus, vertebral body, or carina.
- Any other tumor characteristic making it not suitable for resection as determined by treating surgeon.
- Any prior systemic therapy for index lung cancer, including immunotherapy, chemotherapy.
- History of malignancy requiring systemic therapy within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death as assessed and confirmed by the study PI. (Patients...
- Active or history of clinically significant autoimmune disease that, in the opinion of the investigator, could compromise the health and safety of the patient if treated with anti-PD1 immunotherapy. Notable exceptions...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen.
- Active or history of adrenal insufficiency on stable steroid regimen.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible for the study provided all of following conditions are met: Disease is well controlled at...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Known active tuberculosis.
- Known history of poorly controlled HIV. Patients living with HIV are allowed to enroll if: (1) they are clinically stable on appropriate highly active anti-retroviral therapy (HAART) with undetectable HIV viral load and...
- Known history of poorly controlled hepatitis B or hepatitis C
- Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus (HBV) DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted...
- Patients who are known hepatitis C virus (HCV) antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy)...
- Severe infection within 3 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection (including COVID-19), bacteremia, or severe pneumonia that, in the...
- Prior allogeneic stem cell or solid organ transplantation.
- Any treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study...
- Significant vascular and cardiovascular disease (e.g., New York Heart Association Class II or greater heart failure, unstable arrhythmia, aortic aneurysm requiring surgical repair or recent peripheral arterial...
- Treatment with systemic immunosuppressive medication (including, but not limited to: corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to...
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for...
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- Any prior use of an immune checkpoint blockade therapy including agents directed against CTLA-4, PD-1, and PD-L1.
- History of severe allergic reaction or hypersensitivity to study drug components.
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- St Louis, Missouri, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; St Louis, Missouri, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.