Phase 3 Atezolizumab PD-L1 inhibitor (± hyaluronidase for SC delivery) after Stage I NSCLC resection

National Cancer Institute (NCI) is running AASI-NSCLC, a randomized Phase 3 adjuvant study testing whether 1 year of anti–PD-L1 immunotherapy reduces recurrence after complete (R0) surgery for Stage IA3 or IB NSCLC with high PD-L1 expression (>50%). Patients are assigned to standard post-op observation (active surveillance with scheduled imaging) versus atezolizumab (Genentech/Roche; a PD-L1/CD274–blocking monoclonal antibody) given every 3 weeks for up to 17 cycles; the experimental arm allows either IV atezolizumab or the subcutaneous co-formulation atezolizumab + hyaluronidase-tqjs (Tecentriq Hybreza), where hyaluronidase is an enzyme that increases subcutaneous tissue permeability to enable rapid injection. The key commercial/scientific angle is pushing checkpoint blockade into the earliest, surgically cured-intent population enriched for benefit by very high PD-L1, where today’s care is primarily observation (and, depending on risk features, selective consideration of adjuvant platinum chemo in higher-stage disease rather than routine Stage I). The trial also incorporates CT-based monitoring and optional blood collection for translational analyses.