ArticleTranslational lung cancer research2026
Cadonilimab induction and consolidation for unresectable stage III non-small cell lung cancer patients receiving concurrent chemoradiation: safety run-in results of a prospective, phase II trial.
Article in Translational lung cancer research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Concurrent chemoradiotherapy (cCRT) followed by durvalumab consolidation remains the standard of care for unresectable stage III non-small cell lung cancer (NSCLC). However, treatment outcomes remain suboptimal. Induction immunotherapy has emerged as a potential strategy to preserve systemic immunity and improve local and distant disease control. Cadonilimab (AK104), a bispecific antibody targeting programmed death 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4), has shown promising efficacy in advanced NSCLC. This study sought to assess the safety and efficacy of cadonilimab as both induction and consolidation therapy in unresectable stage III NSCLC. We present the initial safety run-in results of the study. Methods: Eligible patients with driver mutation-negative, unresectable stage III NSCLC received two cycles of cadonilimab plus chemotherapy as induction therapy, followed by standard cCRT and cadonilimab consolidation therapy for up to 1 year or until disease progression, withdrawal of consent, or intolerable toxicity. Dose-limiting toxicity (DLT) was defined as grade 3 non-hematologic toxicity persisting more than seven days, grade 4 non-hematologic toxicity, or grade 5 potentially treatment-related adverse events (TRAEs). Early termination would be triggered if seven or more of the first 20 patients experienced predefined DLTs within 90 days post-cCRT. Results: All patients received at least one cycle of induction therapy, with 19 (95.0%) completing cCRT and 17 (85.0%) proceeding to consolidation therapy. At the data cutoff on June 30, 2025, the median [interquartile range (IQR)] follow-up was 8.4 months (6.2-10.7 months). Four patients (20.0%) experienced DLTs, including two cases of pneumonitis (10.0%), one case of colitis (5.0%), and one case of grade 5 pneumonia (treatment-related etiology not fully excluded). TRAEs occurred in all patients, and most commonly included leukopenia (95.0%), anemia (80.0%), neutropenia (80.0%), pneumonitis (55.0%), and fatigue (50.0%). Most TRAEs were mild; however, 10 (50.0%) patients experienced grade 3-4 non-hematologic TRAEs. Conclusions: Cadonilimab induction and consolidation therapy demonstrated a manageable safety profile in patients with stage III NSCLC, supporting continued enrollment in this ongoing trial.
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