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New treatment option for Lung Non-Small Cell Carcinoma
Official title Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
ClinicalTrials.gov ID: NCT07388524
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lung non-small cell carcinoma.
Also referred to as MPDL 3280A, MPDL 328OA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of atezolizumab (or atezolizumab and recombinant human hyaluronidase) to standard observation for preventing cancer return after surgery (recurrence) in patients who have undergone a complete surgical removal (resection) of stage I non-small cell lung cancer (NSCLC). Patients who have undergone resection for lung cancer are typically followed by observation or active surveillance, which involves closely watching a patient's condition but not giving treatment unless there are changes in test results.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient must have undergone complete surgical resection with negative margins (complete R0 resection). Surgical resection must be lobectomy or...
- 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...
- Patient must have undergone adequate nodal sampling as defined by Commission on Cancer, 2020 Standard. Adequate nodal sampling includes pathological...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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]...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
- Coeur d'Alene, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Springfield, Illinois, United States
- Ames, Iowa, United States
- Cedar Rapids, Iowa, United States
- Fort Dodge, Iowa, United States
- Marshalltown, Iowa, United States
- Bozeman, Montana, United States
- Great Falls, Montana, United States
- Missoula, Montana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States; Coeur d'Alene, Idaho, United States; Post Falls, Idaho, United States; Sandpoint, Idaho, United States; Springfield, Illinois, United States; Ames, Iowa, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.