SWOG clinical trial number
S1914

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC

Open
Phase
III
Accrual
0%
Abbreviated Title
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT versus SBRT Alone in High Risk, Early Stage NSCLC
Status Notes
This study is open to accrual effective March 25, 2020.
Activated
03/25/2020
Participants
CTSU Institutions in the United States

Research committees

Lung Cancer

Treatment

Radiation Therapy Atezolizumab

Other Study Materials

Eligibility Criteria Expand/Collapse

Histologically or cytologically proven Stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC) as defined in Section 4.0, without radiographic evidence of nodal or distant involvement (N0M0). May have T3 disease with the exclusion of multifocal tumors and pericardial involvement.

Disease must have one or more of the following high-risk features: Tumor diameter >= 2 cm as assessed by diagnostic CT; Tumor SUV max >= 6.2 as assessed by FDG PET/CT; Moderately differentiated, poorly differentiated, or undifferentiated histology

Diagnostic chest CT with contrast (unless medically contraindicated) within 42 days prior to randomization. PET-CT may be used if the CT portion is of identical diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization.

FDG PET/CT of chest within 90 days prior to randomization.

Must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional.

History and physical examination within 28 days prior to randomization.

Medically or surgically inoperable as documented by a board certified thoracic surgeon or multi-disciplinary tumor board consensus OR patients unwillingness to undergo surgical resection must be clearly documented.

Must not have received any prior treatment for NSCLC.

Must not have undergone prior radiation to overlapping regions of the chest (such that protocol lung constraints cannot be met with a cumulative plan).

Must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization.

Must be >= 18 years old.

Zubrod Performance Status of 0-2 (see Section 10.3).

Adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN within 28 days prior to randomization.

Adequate renal function defined as calculated creatinine clearance >= 30 mL/min using the formula in protocol. Serum creatinine value used in the calculation must have been collected within 28 days prior to randomization.

ANC, platelets, and hemoglobin measured within 28 days prior to randomization.

TSH measured within 28 days prior to randomization.

Must not have significant cardiovascular disease (NYHA Class II or greater; see Appendix 18.2).

Must not have myocardial infarction within 90 days prior to randomization.

Must not have unstable arrhythmias or unstable angina.

Must not have known left ventricular ejection fraction <40% within 28 days prior to randomization.

Must not have had an infection >= Grade 3 (CTCAE Version 5.0) within 28 days prior to randomization.

Must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

Must be tested for hepatitis B within 28 days prior to randomization. Must not have active (chronic or acute) hepatitis B virus (HBV) infection. May have past or resolved HBV infection.

Must be tested for hepatitis C within 28 days prior to randomization. Must not have active hepatitis C virus (HCV) infection.

Must have an FEV1 >/= 700 cc and a DLCO >/= 5.5 m/min/mmHg from pulmonary function testing documented within 90 days prior to randomization.

Must not have known human immunodeficiency virus (HIV) unless he/she is on effective anti-retroviral therapy, has had at least one viral load test within 6 months prior to randomization, and had undetectable viral load at all viral load tests within 6 months prior to randomization.

Must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT.

No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized prostate cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years.

Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of “reproductive potential” if she has had a menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.

Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization.

Must agree to have specimens submitted for translational medicine and banking as outlined in Section 15.2.

Reports & Approvals

Trial Locations

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