Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2026
SKYSCRAPER-02C: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage SCLC in China.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lu Shun, Fang Jian, Yu Yan, Fan Yun, Dong Xiaorong, Wang Ziping, Wang Qiming, Wang Jialei, Cui Jiuwei, Pan Hongming, Wu Qiong, Lin Chanjuan, Zhang Li, Meng Raymond, Liu Chang, Huang Xiayu, Patil Namrata S
Аннотация
INTRODUCTION: Tiragolumab may synergize with other immunotherapies to enhance antitumor immune responses. We report efficacy, safety, and biomarker findings from SKYSCRAPER-02C (NCT04665856), comparing tiragolumab plus atezolizumab plus carboplatin and etoposide (CE; experimental arm) with atezolizumab plus CE (control arm) in patients with untreated extensive-stage SCLC (ES-SCLC) in China.
METHODS: Patients were randomized (1:1) to tiragolumab 600 mg or placebo, plus atezolizumab 1200 mg and CE (four cycles), then maintenance tiragolumab or placebo plus atezolizumab. Primary end points were investigator-assessed progression-free survival (PFS) and overall survival (OS) in patients without history or presence of brain metastases at baseline (primary analysis set).
RESULTS: The primary analysis set comprised 54 patients in the experimental arm and 56 in the control arm. Median PFS was 5.6 months (experimental) and 5.4 months (control; unstratified hazard ratio = 0.65, 95% confidence interval: 0.43‒0.97; median follow-up 26.7 months); median OS was 18.7 and 13.5 months, respectively (unstratified hazard ratio 0.89, 95% confidence interval: 0.56‒1.40). The biomarker-evaluable population comprised 69 patients with immunohistochemistry data and 66 with RNA sequencing data. RNA sequencing survival analysis found that patients with non-negative matrix factorization 3 (SCLC-inflamed-neuroendocrine) or non-negative matrix factorization 4 (SCLC-inflamed-non-neuroendocrine) molecular subtypes, and those with high T-effector and tumor-associated macrophage immune signatures, benefited from tiragolumab plus atezolizumab plus CE treatment. Tiragolumab was well tolerated, with no new safety signals.
CONCLUSIONS: Although results from the global SKYSCRAPER-02 study were not statistically significant, numerical improvements in PFS and OS were observed with tiragolumab plus atezolizumab plus CE versus atezolizumab plus CE in Chinese patients with ES-SCLC. Biomarker analysis identified immune-inflamed signatures that may guide future tyrosine-based inhibitory motif domain-based strategies.
METHODS: Patients were randomized (1:1) to tiragolumab 600 mg or placebo, plus atezolizumab 1200 mg and CE (four cycles), then maintenance tiragolumab or placebo plus atezolizumab. Primary end points were investigator-assessed progression-free survival (PFS) and overall survival (OS) in patients without history or presence of brain metastases at baseline (primary analysis set).
RESULTS: The primary analysis set comprised 54 patients in the experimental arm and 56 in the control arm. Median PFS was 5.6 months (experimental) and 5.4 months (control; unstratified hazard ratio = 0.65, 95% confidence interval: 0.43‒0.97; median follow-up 26.7 months); median OS was 18.7 and 13.5 months, respectively (unstratified hazard ratio 0.89, 95% confidence interval: 0.56‒1.40). The biomarker-evaluable population comprised 69 patients with immunohistochemistry data and 66 with RNA sequencing data. RNA sequencing survival analysis found that patients with non-negative matrix factorization 3 (SCLC-inflamed-neuroendocrine) or non-negative matrix factorization 4 (SCLC-inflamed-non-neuroendocrine) molecular subtypes, and those with high T-effector and tumor-associated macrophage immune signatures, benefited from tiragolumab plus atezolizumab plus CE treatment. Tiragolumab was well tolerated, with no new safety signals.
CONCLUSIONS: Although results from the global SKYSCRAPER-02 study were not statistically significant, numerical improvements in PFS and OS were observed with tiragolumab plus atezolizumab plus CE versus atezolizumab plus CE in Chinese patients with ES-SCLC. Biomarker analysis identified immune-inflamed signatures that may guide future tyrosine-based inhibitory motif domain-based strategies.