ArticleJTO clinical and research reports2026
SKYSCRAPER-05: A Phase 2 Study of Perioperative Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated, Locally Advanced, Resectable, Stage II‒IIIB NSCLC.
Article in JTO clinical and research reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04832854 (A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer), which is not on this map. Not yet cited in PubMed.
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A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
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Abstract
Introduction: The SKYSCRAPER-05 (NCT04832854), a phase 2, open-label, multicenter study, evaluated perioperative treatment with tiragolumab plus atezolizumab ± platinum-based chemotherapy in treatment-naive patients with resectable, stage II-IIIB NSCLC. Methods: Cohort A (programmed death ligand-1 [PD-L1]-high) received 4 cycles of neoadjuvant tiragolumab (600 mg IV) plus atezolizumab (1200 mg IV) every 3 weeks, surgery, and the investigator's choice of adjuvant tiragolumab plus atezolizumab (16 cycles) or platinum-based chemotherapy (4 cycles). Cohort B (PD-L1 all-comers) received tiragolumab plus atezolizumab plus platinum-based chemotherapy (4 cycles), surgery, and tiragolumab plus atezolizumab every 3 weeks (16 cycles). The co-primary end points were major pathologic response (MPR), surgical feasibility, and safety; the secondary end points were pathologic complete response and event-free survival. Results: At clinical cutoff (February 14, 2024), 50 patients were enrolled (70% male; 66% White), and 48 received treatment (Cohort A, n = 7; Cohort B, n = 41; median follow-up, 9.5 months); 96% of whom underwent resection (4% pneumonectomy, 91% lobectomy or bilobectomy; 93% R0). Cohort A was halted early because of changing treatment paradigms. Cohort B MPR was 51% (95% confidence interval: 35-67) and pathologic complete response was 29% (95% confidence interval: 17-46). Event-free survival was immature. At safety cutoff (March 05, 2025), grade 3 or higher treatment-related adverse events (AEs) occurred in 29% and 44% of patients in Cohorts A and B, respectively; surgery-related grade 3 or higher AEs occurred in 14% and 5%. AEs led to surgical delays in 2 patients and treatment discontinuation in 14 patients (34.1%, all in Cohort B). Conclusions: Perioperative tiragolumab combined with atezolizumab ± chemotherapy proved to be surgically feasible, with acceptable MPR rates and a safety profile aligned with expectations for resectable, locally advanced NSCLC.
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