A Phase II Single-Arm Study of Atezolizumab Monotherapy In Locally Advanced Or Metastatic Non-Small Cell Lung Cancer: Clinical Evaluation Of Novel Blood-Based Diagnostics
- Clements University Hospital
Jonathan Dowell, M.D.
This is a Phase ii, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab in patients with newly diagnosed locally advanced or metastatic nSCLC. in addition, the co-primary biomarker objective is to evaluate various predictive cutoffs for novel blood-based diagnostic assays.
Patients must meet the following criteria for study entry:
* Signed Informed Consent Form
* Age >=18 years
* ECOG performance status of 0 or 1
* Histologically or cytologically confirmed Stage IIIB[?]IVB NSCLC (based on the 8th edition of
the American Joint Committee on Cancer Non[?]Small Cell Lung Cancer Staging system)
* Measurable disease, as defined by RECIST v1.1, based on protocol-specified tumor
x Previously irradiated lesions can only be considered measurable disease if disease
progression has been unequivocally documented at that site since radiation and the
previously irradiated lesion is not the only site of measureable disease
* Adequate hematologic and end-organ function, defined by the following laboratory test
results obtained within 14 days prior to the first dose of study drug:
x ANC >=1500 cells/[MICRO-SYMBOL]L without granulocyte colony-stimulating factor support
x Lymphocyte count >= 500 cells/[MICRO-SYMBOL]L
x Platelet count >= 100,000 cells/[MICRO-SYMBOL]L without transfusion
x Hemoglobin >= 9.0 g/dL
Patients may be transfused to meet this criterion
x INR or activated partial thromboplastin time (aPTT) <= 1.5 x the upper limit of normal
This applies only to patients who are not receiving therapeutic anticoagulation;
patients receiving therapeutic anticoagulation must have an INR or aPTT within
therapeutic limits for at least 1 week prior to enrollment.
x AST, ALT, and alkaline phosphatase <=2.5 x ULN with the following exceptions:
Patients with documented liver metastases: AST and/or ALT <= 5 x ULN
Patients with documented liver or bone metastases: alkaline phosphatase <= 5 x ULN
x Serum bilirubin <=1.5 x ULN
Patients with known Gilbert disease who have a serum bilirubin level <= 3 x ULN may
x Calculated creatinine clearance >= 45 mL/min
* For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use a contraceptive method with a failure rate of <1% per year
during the treatment period and for at least 90 days after the last dose of atezolizumab.
x A woman is considered to be of childbearing potential if she is postmenarcheal, has not
reached a postmenopausal state (>= 12 continuous months of amenorrhea with no
identified cause other than menopause), and has not undergone surgical sterilization
(removal of ovaries and/or uterus).
x Examples of contraceptive methods with a failure rate of < 1% per year include bilateral
tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-
releasing intrauterine devices, and copper intrauterine devices.
x The reliability of sexual abstinence should be evaluated in relation to the duration of the
clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence
(e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are
not acceptable methods of contraception.
Note: The Sponsor has no specific plan to evaluate reliability of abstinence. Patients of child bearing potential must agree to use contraception or be abstinent prior to enrollment. If, during the consent process when the patient is counseled regarding risks and requirements for contraception, the patient states that they will be abstinent as their form contraception, we would further counsel the patient to ensure they understand the definition of abstinence in this setting, and ensure they are aware that periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.