Atezolizumab Immunotherapy in Patients With Advanced NSCLC

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

Phase II trial of induction immunotherapy with atezolizumab for patients with unresectable stage IIIA and IIIB NSCLC eligible for chemoradiotherapy with curative intent.

Key facts

Study ID

NCT03102242

Run by

Alliance Foundation Trials, LLC.

People needed

64

Starts

2017-11-01

Expected to finish

2022-10-01

Last updated by the study team

2023-05-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed stage IIIA/B NSCLC, PS 0-1
• No active autoimmune disease or uncontrolled infection, normal bone marrow, renal, hepatic function, FEV1 > 1.2L, no significant underlying heart or lung disease
• Pathologically proven diagnosis of NSCLC
• Measurable Stage IIIA or IIIB disease
• Tissue available for PD-L1 testing and for correlative science testing
• Patients must be considered unresectable or inoperable. Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met:
• No prior chemotherapy or radiation for this lung cancer.
• Prior curative-intent surgery at least 3 months prior to the nodal recurrence.
• Stage III A or B disease with minimum diagnostic evaluation within 6 weeks to include:
• History/physical examination
• Contrast enhanced CT of the chest and upper abdomen
• MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated)
• PET/CT
• If pleural fluid is visible on CT scan thoracentesis to exclude malignancy should be obtained. Patients with effusions that are too small to tap are eligible.
• Patients must be at least 4 weeks from major surgery and must be fully recovered
• Age greater than or equal to 18 years.
• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks or at least 4 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression.
• If an archived tumor block exists, then either the block or at least 4 unstained slides from the block should be submitted. Tumor tissue should be of good quality based on total and viable tumor content, i.e. at least 50 viable tumor cells and intact tissue architecture. Fine needle aspiration, brushing,and lavage samples are not acceptable. If the block is tissue from a core-needle biopsy, then the block should contain tissue from at least three cores to be sufficient for evaluation.
• Patients who do not have existing (archived) tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. Acceptable samples include core needle biopsies for deep tumor tissue (minimum of three cores) or excisional, or forceps biopsies for endobronchial or nodal lesions. The tissue should be fixed in formalin and embedded on site and sent as a block.
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1):
• ANC ≥ 1500 cells/µL
• WBC counts > 2500/µL
• Lymphocyte count ≥ 300/µL
• Platelet count ≥ 100,000/µL
• Hemoglobin ≥ 10.0 g/dL

You may not qualify if…

• Active autoimmune disease
• Greater than minimal, exudative, or cytologically positive pleural effusions
• Involved contralateral hilar nodes
• 10% weight loss within the past month
• Known EGFR exon 19 or 21 mutation or ALK rearrangement
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, localized prostate cancer, carcinoma in situ of the oral cavity, or cervix are all permissible.
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Prior severe infusion reaction to a monoclonal antibody
• Severe, active co-morbidity, defined as follows:
• Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration or within 2 weeks of cycle 1 day 1.
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, HIV testing is required for entry into this protocol due to the immunologic basis for induction treatment.
• Pregnancy, lactation, or inability or unwillingness to use medically acceptable forms of contraception if pregnancy is a risk.
• Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin;
• Uncontrolled neuropathy grade 2 or greater regardless of cause.
• Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed:
• i. Hormone-replacement therapy or oral contraceptives ii. Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1)
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible.
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• Inability to comply with study and follow-up procedures

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• EMMC Cancer Care — Brewer, Maine, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Metro MN Community Oncology Research Consortium — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Ohio State University James Cancer Center — Columbus, Ohio, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Prisma Health Greenville Memorial Hospital — Greenville, South Carolina, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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