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New treatment option for Non-Small Cell Lung Cancer
Official title A Study Evaluating Neoadjuvant Chemoimmunotherapy With Immunosensitizing Radiation for Borderline Resectable Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06800339
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
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 purpose of this research study is to find out if adding radiation prior to chemoimmunotherapy and surgery is effective for people with non-small cell lung cancer (NSCLC) who have the potential for surgery. Standard of Care Chemoimmunotherapy: For this study, standard of care chemotherapy will be used.
- Phase 1: an early, usually small safety study
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 greater than or equal to18 years at time of study entry
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Participants with histologically confirmed stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer) with disease...
You likely can't join if
- for further details)
- Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the...
- Participants must have a tumor tissue sample available for biomarker testing, including next-generation sequencing to confirm EGFR/ALK status...
- Absence of major associated pathologies that increase the surgery risk to an unacceptable level
- Pulmonary function capacity (eg. FVC, FEV1, TLC, and DLCO) capable of tolerating proposed lung resection according to surgeon.
- Adequate normal organ and marrow function defined below:
See the full eligibility criteria
- Age greater than or equal to18 years at time of study entry
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- Participants with histologically confirmed stage II-IIIC(N3) NSCLC (per the 8th International Association for the Study of Lung Cancer) with disease that is considered borderline resectable prior to initiation of RT or...
- for further details)
- Subject cases must be reviewed in a multidisciplinary thoracic tumor board setting prior to enrollment to allow for adequate discussion regarding the potential for resection.
- Participants must have a tumor tissue sample available for biomarker testing, including next-generation sequencing to confirm EGFR/ALK status. Assessment of EGFR/ALK status may be performed locally through a CLIA...
- Absence of major associated pathologies that increase the surgery risk to an unacceptable level
- Pulmonary function capacity (eg. FVC, FEV1, TLC, and DLCO) capable of tolerating proposed lung resection according to surgeon.
- Adequate normal organ and marrow function defined below:
- Platelet count greater than or equal to100,000/mm3
- Hemoglobin greater than or equal to 8 g/dL
- Absolute neutrophil count (ANC) greater than or equal to 1000/mm3
- Creatinine less than or equal to 1.5 x ULN or creatinine clearance (CrCl) greater than or equal to 40 mL/min
- Total bilirubin less than or equal to 1.5 x ULN (except people with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL)
- AST, ALT, Alkaline phosphatase less than or equal to 3 x ULN per local testing
- people are deemed capable of giving informed consent and must have signed and dated an IRB approved written informed consent form. This written consent must be obtained before the performance of any protocol related...
- Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy testing within 30 days of study start. Exclusion Criteria:
- Presence of metastatic (Stage IV) disease, including malignancy pleural effusions.
- Participants with N3 disease involving ipsilateral or contralateral scalene or supraclavicular lymph nodes. In the case of clinical suspicion for involvement of these lymph nodes, pathologic confirmation and biopsy may...
- Participants with known sensitizing EGFR (L858R or Exon 19 deletion) mutations or ALK translocation. If testing is done, an FDA approved assay should be used and testing can be performed locally.
- Participants with brain metastases are excluded from this study. All patients should have pre-study MRI brain or CT head with contrast to confirm the absence of intracranial disease, per standard of care staging...
- Participants with active autoimmune disease which would preclude immunotherapy. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis...
- Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical...
- Participants with serious or uncontrolled medical disorders.
- Participants with large-cell neuroendocrine carcinoma tumor histology.
- Prior administration of chemotherapy or any other cancer therapy for early-stage NSCLC.
- Prior therapy with an anti-PD-(L)1, anti-CTLA-4 antibody or any other antibody targeting t-cell co-regulatory pathways.
- Participants with active hepatitis B (positive hepatitis B surface antigen) or hepatitis C virus (positive HCV RNA).
- Participants with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody and the absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to...
- Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Participants with poorly controlled or untreated human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). All of the following criteria are required to define an HIV infection that is well...
- Active prior malignancy within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the...
- History of allergy or hypersensitivity to nivolumab, or chemotherapy agents.
- History of allogeneic organ transplantation.
- Female patients who are pregnant or actively breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control methods from time of screening to 90 days after...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Glen Burnie, Maryland, 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 Baltimore, Maryland, United States; Bel Air, Maryland, United States; Glen Burnie, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.