Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02994576 : Atezolizumab as Induction Therapy in Non-small Cell Lung Cancer
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Age ? 18 years

- Histologically documented NSCLC

- Clinical Stage IB (? 4 cm)-IIIA non N2 NSCLC eligible for surgical resection • Initial
work-up including petscan and brain RMI for staging

- Measurable disease, as defined by RECIST v1.1.

- Apt to surgical resection by a lobectomy or bilobectomy procedure

- ECOG performance status of 0 or 1 (appendix 3)

- Adequate hematologic and organ function, defined by the following laboratory results
obtained within 14 days prior to registration:

- White blood cell (WBC) counts > 2.5 x 109/L

- Absolut neutrophil count (ANC) ? 1.5 x 109/L (without granulocyte
colony-stimulating factor support within 2 weeks prior to Day 1)

- Lymphocyte count ? 0.5 x 109/L

- Platelet count ?100 x 109/L

- Hemoglobin ? 9.0 g/dL. Patients may be transfused to meet this criterion.

- AST, ALT, and alkaline phosphatase ? 2.5 X the upper limit of normal (ULN),

- Serum bilirubin ? 1.5 X ULN. Patients with known Gilbert disease who have serum
bilirubin level ? 3 X ULN may be enrolled.

- International Normalized Ratio (INR) and activated Partial Thromboplastin Time
(aPTT) ? 1.5 X ULN -This applies only to patients who are not receiving
therapeutic anticoagulation; patients receiving therapeutic anticoagulation
should be on a stable dose.

- Creatinine clearance ? 60 mL/min on the basis of the Modification of Diet in
Renal Disease (MDRD)

- Serum albumin ?2.5 g/dL

- Calcemia ? 2.65 mmol/L or Ca ?10 mg/dL

- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
within 14 days before the registration and must be willing to use two methods of
contraception, one of them being a barrier method, or to abstain from sexual activity
during the study and for 5 months after last study drug administration. Sexually
active males and their female partners must agree to use two methods of accepted and
effective contraception (hormonal or barrier methods, abstinence) prior to study entry
and for the duration of the study.

- Information delivered to the patient and informed consent form signed by the patient

- Ability to comply with the protocol procedures

- Patient affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

- History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ
cervical carcinoma for at least five years before registration.

- Prior therapy for lung cancer

- Pregnant and breast feeding women

- History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins

- Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component
of the atezolizumab product

- History of autoimmune disease, including but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associated with antiphospholipid
syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,
multiple sclerosis, Type I diabetes mellitus, vasculitis, or glomerulonephritis (see
Appendix 5 for a more comprehensive list of autoimmune diseases). Patients with a
history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement
hormone may be eligible for this study.

- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan

- History of HIV infection

- Patients with active hepatitis B (chronic or acute) or hepatitis C Patients with
past/resolved HBV infection (defined as the presence of anti-hepatitis B core
antibody, IgG anti-HBs + and absence of HbsAg) are eligible. HBV DNA should be
obtainedin these patients prior to Day 1.

Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.

- Active tuberculosis

- Severe infections within 4 weeks prior to registration, including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia

- Signs or symptoms of infection within 2 weeks prior to registration

- Significant cardiovascular disease, such as New York Heart Association cardiac disease
(Class II or greater), myocardial infarction within the previous 3 months, unstable
arrhythmias, or unstable angina

- Patients with known coronary artery disease, congestive heart failure not meeting the
above criteria, or left ventricular ejection fraction <50% must be on a stable medical
regimen that is optimized in the opinion of the treating physician, in consultation
with a cardiologist if appropriate.

- Major surgical procedure other than for diagnosis within 28 days prior to registration
or anticipation of need for a major surgical procedure during the course of the study

- Prior allogeneic stem cell or solid organ transplant

- History of any hematological disease not considered in complete remission for at least
five years before registration.

- Administration of a live, attenuated vaccine within 4 weeks before registration or
anticipation that such a live attenuated vaccine will be required during the study or
for 5 months after study drug administration. Influenza vaccination should be given
during influenza season only (approximately October to March).

Patients must not receive live, attenuated influenza vaccine (e.g., FluMistâ) within 4
weeks prior to registration or at any time during the study.

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complications

- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
anti-CTLA4, anti-PD-1, and anti-PD-L1 therapeutic antibodies

- Treatment with systemic immunostimulatory agents (including but not limited to
interferons, interleukin-2) within 6 weeks or five half-lives of the drug, whichever
is shorter, prior registration

- Treatment with systemic immunosuppressive medications (including but not limited to
prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor
necrosis factor [anti-TNF] agents) within 2 weeks prior to registration

- Patients who have received acute, low-dose, systemic immunosuppressant medications
(e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study after
discussion with and approval by the coordinating investigator. The use of inhaled
corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02994576      |      Link to official Clinicaltrials.gov listing
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