NCT04952597

Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer

A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .

Conditions

• Limited Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ociperlimab	Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
DRUG	Tislelizumab	Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
DRUG	Concurrent Chemoradiotherapy	Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)

Timeline

• Start date: 2021-07-15
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2021-07-07
• Last updated: 2024-10-26
• Results posted: 2024-09-19

Locations

33 sites across 3 countries: United States, China, South Korea

Regulatory

• FDA-regulated drug study