New combo therapy shows promise for inoperable lung cancer
NCT ID NCT02599454
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tested a combination of an immunotherapy drug (atezolizumab) and precise radiation therapy (SBRT) in 20 people with stage I non-small cell lung cancer who couldn't have surgery. The main goal was to find the safest dose and check for side effects. Researchers also looked at how long patients stayed cancer-free and whether tumors shrank.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atezolizumab (a drug that helps the immune system fight cancer) and stereotactic body radiation therapy (high-precision radiation)
- What this could lead to
- If this combination proves safe and effective, it could offer a new treatment option for people with early-stage lung cancer who cannot have surgery.
- What could go wrong
- This is a very early (phase I) trial with only 20 participants, so results may not apply to everyone. The main goal was safety, not yet proving the treatment works better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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20 people
The number who actually took part.
- Started
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Apr 2018
- Finished
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Feb 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically proven stage I NSCLC =\< 5 cm diameter * One or more high-risk features identified: * Tumor diameter \>= 2 cm * Tumor standardized uptake value maximum (SUVmax) \>= 6.2 * Moderately, poorly differentiated or undifferentiated histology * Evaluable disease per RECIST 1.1 * Patients must be medically or surgically inoperable as determined by a physician OR unwilling to undergo surgical resection * All patients must have an forced expiratory volume in 1 second (FEV1) \>= 700cc * All patients must have a carbon monoxide diffusing capability test (DLCO) \>= 5.5 m/min/mmHg * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 * Life expectancy \>= 12 months * Absolute neutrophil count (ANC) \> 1500 cells/uL * White blood cell count (WBC) \> 2500/uL * Lymphocyte count \> 500/uL * Platelet count \> 100,000/uL * Hemoglobin \> 9 g/dL * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN) with alkaline phosphatase =\< 2.5 x ULN OR AST and ALT =\< 1.5 x ULN, with alkaline phosphatase \> 2.5 x ULN * Serum bilirubin =\< 1.0 x ULN * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) \< 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to enrollment) * Creatinine clearance \> 30 mL/min by Cockcroft-Gault formula * No history of severe hypersensitivity reactions to other monoclonal antibodies (mAbs) * No other active malignancy * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible * Archival tumor sample available; tissue from an fine-needle aspiration (FNA) is allowed but tumor tissue from a core needle biopsy is preferred * For female patients of childbearing potential and male patients with partners of childbearing potential agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\< 1% per year\] when used consistently and correctly) and to continue its use for 6 months after the last dose of MPDL3280A * Signed informed consent * Ability to comply with the protocol Exclusion Criteria: * Uncontrolled concomitant disease * Significant cardiovascular disease (New York Heart Association Class \[NYHA\] class II or greater); myocardial infarction within 3 month prior to randomization, unstable arrhythmias, unstable angina or a patient with a known left ventricular ejection fraction (LVEF) \< 40% * Severe infection within 4 weeks prior to enrollment * Active tuberculosis * Oral or IV antibiotics within 2 weeks or 5 half-lives prior to enrollment * History of autoimmune disease * Positive for human immunodeficiency virus (HIV), hepatitis B (hepatitis B surface antigen \[HBsAg\] reactive), or hepatitis C virus (hepatitis C virus ribonucleic acid \[HCV RNA\] \[qualitative\] is detected) * History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia * Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrollment * Treatment with systemic corticosteroids or other systemic immunosuppressive medications within past 4 weeks or 5 half-lives whichever is shorter * Pregnant and/or lactating women
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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David Grant United States Air Force Medical Center
Travis AFB, California, 94535-1800, United States
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
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