| Eligibility |
Inclusion Criteria:
- Biopsy-proven NSCLC primary with PD-L1 expression = 1%
- At least one previously untreated, asymptomatic brain metastases (<=10 total) with at
least one measurable (0.5 cm diameter or larger) as assessed by MRI
- No prior systemic treatment for metastatic NSCLC.
- age = 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Life expectancy greater than six (6) months
- Adequate normal organ and marrow function
- Body weight greater than 30 kg
- Ability to understand and willingness to sign written informed consent
Exclusion Criteria:
- Brain metastases that are symptomatic and/or with recent (<10 days) steroid use
- 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]).
- Subjects may not be receiving any other investigational agents for the treatment of
the cancer under study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social
situations that, in the opinion of the investigator, would limit compliance with study
requirements, substantially increase risk of incurring AEs or compromise the ability
of the patient to give written informed consent.
- Subjects must not be pregnant or nursing due to the potential for congenital
abnormalities and the potential of this regimen to harm nursing infants.
- Administration of one or more lines of systemic therapy for the diagnosis of
metastatic non-small cell lung cancer
- Prior receipt of systemic therapy for the management of high-risk early stage or
locally advanced non-small cell lung cancer, prior to the development of metastatic
disease, would not count towards the number of receipt of systemic therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to durvalumab or other agents used in study
- Male or female patients of reproductive potential who are not willing to employ
effective birth control from screening to 90 days after the last dose of durvalumab
monotherapy
- Participation in another clinical study with an investigational product during the
last 1 month
- Concurrent enrolment in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an
interventional study
- Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine
therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal
antibodies) = 7 days prior to the first dose of study drug If sufficient wash-out time
has not occurred due to the schedule or PK properties of an agent, a longer wash-out
period will be required, as agreed by AstraZeneca and the investigator
- Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the
exception of alopecia, vitiligo, nausea, anorexia/weight loss, and the laboratory
values defined in the inclusion criteria:
- Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after
consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by
treatment with durvalumab may be included only after consultation with the Study
Physician.
- Any other concurrent immunotherapy, biologic, or hormonal therapy for cancer
treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g.,
hormone replacement therapy) is acceptable.
- Major surgical procedure (as defined by the Investigator) within 14 days prior to the
first dose of immunotherapy.
- History of allogenic organ transplantation
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease =5 years
before the first dose of immunotherapy and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
disease
- Adequately treated carcinoma in situ without evidence of disease
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and TB testing in line with
local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),
hepatitis C
- Current or prior use of immunosuppressive medication within 14 days before the first
dose of durvalumab
- Receipt of live attenuated vaccine within 30 days prior to the first dose of
immunotherapy
- Receipt of any prohibited medication
|
