Status and phase
Conditions
Treatments
About
This is a phase 3, open-label, 4-cohort study (3 randomized cohorts and 1 single-arm cohort). Participants enrolled in each cohort will be treated as detailed below. Each study cohort will be analyzed separately. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.
Full description
Participant enrollment will only occur for Cohort D. Cohort D will evaluate the efficacy and safety of N-803 in combination with chemoimmunotherapy containing approved CPIs (nivolumab plus ipilimumab) as first-line treatment for participants with stage III or IV squamous or nonsquamous NSCLC.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Cohorts A, B, C Inclusion Criteria:
Cohorts A, B, C Exclusion Criteria:
Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
A history of prior malignancy with the following exceptions: cancer treated with curative therapy with no disease recurrence for >3 years, non-metastatic prostate cancer controlled with hormonal therapy, or under observation; non-metastatic thyroid cancer; basal or squamous cell carcinoma of the skin, superficial bladder cancer, or in situ cervical cancer that has undergone successful definitive resection.
Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma).
History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroid use to manage AEs are permitted.
Prior systemic chemotherapy, major surgery, or thoracic radiation within 3 weeks of study initiation.
Requirement for other forms of anticancer treatment while on trial, including maintenance therapy, other radiation therapy, and/or surgery. Palliative radiation is permitted.
Known CNS metastases or carcinomatous meningitis. Subjects with previously treated, stable CNS metastases (no evidence of progression for ≥ 4 weeks, and resolution of neurologic symptoms to baseline state) are permitted in this study.
History of receiving a live vaccine 30 days prior to study treatment.
History of human immunodeficiency virus (HIV), or known active hepatitis B or C infection.
An active infection requiring systemic IV therapy.
History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Inadequate organ function, evidenced by the following laboratory results:
Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
Known hypersensitivity to any component of the study medication(s).
Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to screening for this study, except for testosterone-lowering therapy in men with prostate cancer.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Concurrent participation in any interventional clinical trial.
Pregnant and nursing women.
Cohort D Inclusion criteria
Cohort D Exclusion criteria
Prior systemic therapy or radiation therapy for treatment of current advanced or metastatic NSCLC.
Have known EGFR mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations). All participants with nonsquamous histology must have been tested for EGFR mutation status; use of an approved test is strongly encouraged. Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded.
Have known ALK translocations which are sensitive to available targeted inhibitor therapy are excluded. If tested, use of an approved test is strongly encouraged.
Participants with unknown or indeterminate ALK status may be enrolled.
Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). Participants must have been off treatment for 180 days.
History of organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroid use to manage AEs are permitted.
Requirement for other forms of anticancer treatment while on trial, including maintenance therapy, radiation therapy, and/or surgery. Palliative radiation is permitted.
Participants with untreated CNS metastases and carcinomatous meningitis are excluded.
Participants are eligible if CNS metastases are adequately treated and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to first treatment. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone.
Active infection requiring systemic IV therapy.
History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
Inadequate organ function, evidenced by the following laboratory results:
Participants taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to the start of treatment on this study, except for hormone-lowering therapy in participants with hormone-sensitive cancer.
Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
Pregnant and nursing women.
Primary purpose
Allocation
Interventional model
Masking
1,538 participants in 7 patient groups
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Data sourced from clinicaltrials.gov
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