A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

Summary

This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (\</= upper limit of normal \[ULN\] vs. \> ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: * Arm A: Tiragolumab plus atezolizumab plus CE * Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Timeline

Start

2020-02-04

Primary completion

2022-09-06

Completion

2025-07-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: Placebo + Atezolizumab vs Arm B: Tiragolumab + Atezolizumab; p = 0.3504; Hazard Ratio (HR) 1.11 (95% CI 0.89 to 1.38); Log Rank NCT04256421 ↗

registry analysis (superiority test); Arm A: Placebo + Atezolizumab vs Arm B: Tiragolumab + Atezolizumab; p = 0.2859; Hazard Ratio (HR) 1.14 (95% CI 0.90 to 1.44); Log Rank NCT04256421 ↗

paper final analysis of PFS in the PAS (n = 397) did not reach statistical significance (stratified hazard ratio [HR], 1.11; P = .3504; median, 5.4 months tiragolumab v 5.6 months control). PMID 37976444 ↗

paper CONCLUSION: Tiragolumab did not provide additional benefit over atezolizumab and CE in untreated ES-SCLC. PMID 37976444 ↗

Publications

• Rudin CM, Liu SV, Soo RA, Lu S, Hong MH, Lee JS, Bryl M, Dumoulin DW, Rittmeyer A, Chiu CH, Ozyilkan O, Johnson M, Navarro A, Novello S, Ozawa Y, Tam SH, Patil NS, Wen X, Huang M, Hoang T, Meng R, Reck M. SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. J Clin Oncol. 2024 Jan 20;42(3):324-335. doi: 10.1200/JCO.23.01363. Epub 2023 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tiragolumab	Monoclonal antibody	600 mg	Intravenous
Background	Atezolizumab	Monoclonal antibody	1200 mg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous

Indications