Non Small Cell Lung Cancer Clinical Trial
— ATLASOfficial title:
Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer
The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumors.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 1, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years at the time of screening or age of consent. - Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Weight = 35 kg. - Must have a life expectancy of at least 12 weeks. - Recurrent or newly diagnosed metastatic non-small cell lung cancer - Tumor PDL1 status <50%. - Non-Squamous and squamous histologies are eligible - Histologies with targetable mutations (EGFR, ALK, ROS1) are not eligible, regardless of prior treatment with tyrosine kinase inhibitors - No prior radiation, surgery or chemotherapy is allowed for the current diagnosis of non-small cell lung cancer - Adequate organ and marrow function Exclusion Criteria: - Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment. - Prior receipt of any immune-mediated therapy. - Incomplete surgical resection - Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed. - Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent. - Participants with prior history of myocardial infarction, transient ischemic attack, congestive heart failure = Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment. - Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with exceptions. - Participants with confirmed human immunodeficiency virus (even if viral load is undetectable), chronic or active hepatitis B or C, or active hepatitis A. - History of primary immunodeficiency, solid organ transplantation, or active tuberculosis (by clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). - Other invasive malignancy within 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition. - Known allergy or hypersensitivity to investigational product formulations. - History of more than one event of infusion related reactions requiring permanent discontinuation of intravenous drug treatment. - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring antibiotic therapy, uncontrolled hypertension, bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events, or compromise the ability of the subject to give written informed consent. - Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with exceptions. - Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment - Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. - Females who are pregnant, lactating, or intend to become pregnant during their participation in the study. - Participants who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures. - Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results. |
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Bristol-Myers Squibb |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months | 6 months | ||
Secondary | Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 3 weeks | 3 weeks | ||
Secondary | Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 12 weeks | 12 weeks | ||
Secondary | Number participants with adverse events | 4 years | ||
Secondary | Average time from the date of study enrolment until death (overall survival) | 4 years |
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