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Protocol No. UW17003
Principal Investigator Bassetti, Michael
Age Group Adult
Sponsor Type Industry; Institutional
Title Comprehensive stereotactic body radiotherapy (SBRT) to all sites of oligometastatic non-small cell lung cancer (NSCLC) combined with durvalumab and tremelimumab dual immune checkpoint inhibition
Objective The purpose of this study is to see if the combination of durvalumab and tremelimumab with stereotactic body radiotherapy in the treatment of oligometastatic non-small cell lung cancer would be more effective then standard of care chemotherapy and to collect information on the safety of these medications.
Treatment Stereotactic Body Radiation Therapy (SBRT) once daily for 5 days a week for 2 weeks, followed by a research biopsy if deemed appropriate, followed by chemotherapy consisting of Durvalumab and Tremelimumab intravenously every 4 weeks for 4 doses followed by Durvalumab every 4 weeks until disease gets worse.
Description Phase 1b study of stereotatic body radiotherapy(SBRT) in oligometastatic non-small cell lung cacner(NSCL) with dual immue checkpoint inhibition
Patients with histologically or cytologically confirmed non-small cell lung cancer not amendable to curative surgery or radiation
Patients may have had prior chemotherapy or be chemotherapy naïve
Patients must have tumors that lack sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) or ALK rearrangement. If a patient has squamous histology, then EGFR and ALK testing is not required
No prior treatment with cancer immunotherapy
Patients will have 6 or less extracranial sites
Patients must have evaluable disease
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
Patients treated metastatic lesions to the brain may be enrolled after completing stereotactic radiosurgery (may enroll 14 days after treatment) or whole brain radiation (may enroll 14 days after treatment) and being weaned off corticosteroids(may enroll 14 days after weaning)
Adequate normal organ and marrow function
Female subjects of childbearing potential should be willing to use highly effective birth control
No mixed small-cell lung cancer and sarcomatoid variant NSCLC histology
No prior treatment with a PD1 or PD-L1 inhibitor, including durvalumab or an antiCTLA4 inhibitor including tremelimumab
Patients with a known targetable EGFR mutation or ALK rearrangement are not eligibile
No active or prior documented autoimmune or inflammatory disorders.
No history of primary immunodeficiency
No history of allogeneic organ transplant
No known history of previous clinical diagnosis of tuberculosis
No history of leptomeningeal carcinomatosis
No uncontrolled seizures.
No history of medically diagnosed pneumonitis or interstitial lung disease
Applicable Disease Sites Lung
Participating Institutions UW Hospital and Clinics