Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer (ATLAS)

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 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.