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About
The purpose of this study is to find out whether treatment with the study drug durvalumab combined with a type of radiation therapy called stereotactic body radiation (SBRT) is a more effective treatment for early-stage non-small cell lung cancer (NSCLC) than SBRT alone.
Enrollment
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Inclusion criteria
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol- related procedures.
Patient age ≥ 18 at time of consent
Early stage NSCLC (Stage I to IIIA; T1-4 excluding patients with satellite nodules in the same or ipsilateral lobes, N0; AJCC 8th edition)
Ineligible for or unwilling to undergo surgical resection. Reasons for surgical ineligibility include: medically inoperable or surgically unresectable (due to tumor size, location etc.), as assessed by MSKCC thoracic surgeon or multi-disciplinary tumor board consensus. Reasons for ineligibility or patient's unwillingness to undergo surgical resection must be clearly documented.
Histological and/or cytological confirmation of NSCLC as per standard of care biopsy; no additional research protocol-specific biopsy is needed.
ECOG/WHO PS 0-1 (KPS 70-100)
Candidates for definitive SBRT
° If, after candidates have been planned for RT, they are unable to be treated with the institutional dose constraints as listed in the appendix, they will be labeled ineligible and removed from the study. Ineligible patients will be replaced.
A predicted 2-year PFS of <80% (≥20% risk for disease progression) based on an MSKCC-developed radiomics risk prediction model (see section 9.0).
Body weight > 30kg
Adequate normal organ and marrow function as defined below:
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age- specific requirements apply:
Must have a life expectancy of at least 12 weeks
Exclusion criteria
Participation in another clinical study with an investigational product during the last 4 weeks.
Previous thoracic radiation precluding definitive SBRT to the current tumor.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Prior/Current Therapies:
i. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) ii. Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) e. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. f. Prior chemotherapy for this diagnosis of lung cancer
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
History of allogenic organ transplantation.
Severe concurrent illness:
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ a highly effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
a. Highly effective methods of contraception, defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly are described in Appendix B. Note that some contraception methods are not considered highly effective (e.g. male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel which is considered highly effective]; and triphasic combined oral contraceptive pills).
Live vaccination within 4 weeks prior to the first dose of durvalumab and while on trial is prohibited except for administration of inactivated vaccines.
Connective tissue disorders or idiopathic pulmonary fibrosis involving the lungs and/or esophagus
Known actionable EGFR or ALK mutation
Known contraindications to radiotherapy
History of leptomeningeal carcinomatosis
History of active primary immunodeficiency
Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
Participants must not donate blood while on durvalumab therapy.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
Charles Simone, MD; Maria Thor, PhD, MS
Data sourced from clinicaltrials.gov
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