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.
Shun Lu, Jian Fang, Yan Yu et al.
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In 30 seconds
SKYSCRAPER-02C was a phase 3, randomized, double-blind, placebo-controlled trial comparing tiragolumab plus atezolizumab and carboplatin–etoposide with atezolizumab and chemotherapy alone in Chinese patients with untreated extensive-stage small-cell lung cancer. In the primary analysis set without baseline brain metastases, median progression-free survival was 5.6 versus 5.4 months (unstratified hazard ratio 0.65, 95% confidence interval: 0.43‒0.97); median overall survival was 18.7 versus 13.5 months (unstratified hazard ratio 0.89, 95% confidence interval: 0.56‒1.40). Tiragolumab was well tolerated, with no new safety signals.
Key findings
- Median progression-free survival was 5.6 months with tiragolumab and 5.4 months with control (unstratified hazard ratio = 0.65, 95% confidence interval: 0.43‒0.97).
- Median overall survival was 18.7 versus 13.5 months (unstratified hazard ratio 0.89, 95% confidence interval: 0.56‒1.40).
- RNA sequencing analyses suggested benefit in patients with specified inflamed molecular subtypes or high T-effector and tumor-associated macrophage immune signatures.
- Tiragolumab was well tolerated, with no new safety signals.
Why it matters
The trial provides randomized evidence on adding tiragolumab to an established immunotherapy–chemotherapy regimen for untreated extensive-stage disease in Chinese patients. The progression-free survival result was numerically favorable, while the overall survival estimate was less conclusive. Exploratory biomarker findings may help shape future research, but do not establish which patients should receive the combination.
What to keep in mind
The primary analysis set was limited to patients without brain metastases at baseline. Biomarker findings were based on smaller evaluable subsets and are exploratory; the abstract does not report confirmatory validation.