Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

- Pathologically stage IA3 or IB NSCLC per American Joint Committee on Cancer (AJCC)
Cancer Staging Manual, 9th edition

- Note: Tumors with any histology are allowed including both squamous and
non-squamous subtypes, except those containing small-cell morphology.
Non-squamous histology includes adenocarcinoma, large cell neuroendocrine,
poorly differentiated tumors and adenosquamous, etc

- Patient must have undergone complete surgical resection with negative margins
(complete R0 resection). Surgical resection must be lobectomy or higher, unless the
tumor measured no more than 2 cm based on clinical staging, where sub-lobar
resection, e.g., wedge or segmentectomy, will be acceptable

- Note: For patients who underwent sub-lobar resection for clinical tumors size
of ≤ 2.0 cm, must have CT chest confirming tumor size within 60 days of
surgical resection. Patients who received a lobectomy or higher do not require
to fulfill this imaging criteria

- Patient must have undergone adequate nodal sampling as defined by Commission on
Cancer, 2020 Standard. Adequate nodal sampling includes pathological evaluation of
at least one (named and/or numbered) hilar station (level 10 or higher) and at least
three distinct (named and or numbered) mediastinal stations (level 2-9)

- PD-L1 immunohistochemistry showing tumor proportion score (TPS) ≥ 50%, by an Food
and Drug Administration (FDA)-approved assay including but not limited to SP263,
SP142, 22C3, 28-8, performed either on surgical specimen or biopsy specimen

- No EGFR exon 19 deletion (del) or L858R mutation or ALK fusion; molecular testing
may have been performed either on surgical specimen or biopsy specimen. Tumors with
purely squamous histology are not required to undergo EGFR or ALK gene testing

- Patient to be registered to A082302 no earlier than 21 days and no later than 77
days from surgical resection

- Recovered from surgical resection as determined by the treating provider or the
investigator

- No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis

- Patient must NOT have uncontrolled intercurrent illness, including but not limited
to serious ongoing or active infection, symptomatic congestive heart failure (New
York Heart Association [NYHA] class ≥ III), unstable angina, or unstable arrhythmia

- No current pneumonitis or history of (non-infectious) pneumonitis that required
steroids or history of interstitial lung disease (ILD)

- No active auto-immune disease that has required systemic treatment within the last 2
years (e.g., disease modifying agents, corticosteroids, or immunomodulatory agents).
Replacement therapy (e.g., thyroid for history of autoimmune thyroiditis, insulin
for type I or II diabetes, corticosteroids for adrenal or pituitary insufficiency)
is not considered a form of systemic treatment

- No known hypersensitivity (≥ grade 3) to atezolizumab and/or any of its excipients

- No live vaccine within 30 days prior to registration. Examples include but are not
limited to: measles, mumps, rubella, varicella, yellow fever, Bacillus
Calmette-Guerin (BCG), typhoid, nasally administered influenza

- No history of prior allogeneic bone marrow, stem cell, or solid organ transplant

- Patient has not received continuous systemic treatment with corticosteroids (> 10 mg
daily prednisone or equivalents) or other immunosuppressive medications within 14
days prior to registration, with the following exceptions:

- Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily
prednisone equivalents are permitted in the absence of active autoimmune
disease. Patients are permitted to use topical, ocular, intra-articular,
intranasal, and inhalational corticosteroids (with minimal systemic
absorption). Physiologic replacement doses of systemic corticosteroids are
permitted, if < 10 mg/day prednisone equivalents. A brief course of
corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment
of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction
caused by contact allergen or chronic obstructive pulmonary disease [COPD]
exacerbation) is permitted

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥
60%)

- Absolute neutrophil count (ANC) ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), except patients with Gilbert
syndrome who can have total bilirubin < 3.0 mg/dl

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase
[SGPT]) ≤ 3 x upper limit of normal (ULN)

- Creatinine clearance ≥ 30 mL/min (using standard Cockcroft-Gault formula, unless
measured creatinine clearance [CrCl] is available and meet the specified threshold)

- Not pregnant and not nursing, because this study involves an agent that has known
genotoxic, mutagenic and teratogenic effects

- Therefore, for women of childbearing potential only, a negative urine or serum
pregnancy test done ≤ 7 days prior to registration is required

- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial

- HIV: Patients with known HIV infection on effective anti-retroviral therapy
with undetectable viral load within 6 months prior to registration are eligible
for this trial. Patients with no known history of HIV do not require any
testing

- Hepatitis B and hepatitis C: No active hepatitis B (defined as negative for
hepatitis B [HepB] deoxyribonucleic acid [DNA], and positive for HepB surface
antibody) or hepatitis C (defined as hepatitis C virus [HCV] ribonucleic acid [RNA]
[qualitative] detected) infection. If there is a history of either infection,
patient should be negative for active disease, for hepatitis B negative for
hepatitis B virus surface antigen (HBsAg), and for hepatitis C - negative for HCV
RNA (qualitative). Patients with no known history of chronic hepatitis do not
require any testing

- No active infection requiring systemic therapy

- Cardiac function: Patients with known history or current symptoms of heart failure,
or history of treatment with cardiotoxic agents, should have a clinical risk
assessment of cardiac function using the New York Heart Association functional
classification. To be eligible for this trial, patients should be class 2B or better