CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Ociperlimab +2 moredrug
Likely dose
Ociperlimab 900 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04952597
NCT04952597Phase 2Completed

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

BeiGene·interventional·Posted Jul 7, 2021·Updated Oct 26, 2024

In Brief

A Phase 2 clinical trial evaluating Ociperlimab, Tislelizumab, and 1 other intervention for Limited Stage Small Cell Lung Cancer. Completed, enrolled 126 participants across 33 sites in 3 countries.

Detailed 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 .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 7, 2021
Enrollment StartJul 15, 2021
Primary CompletionJul 26, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.0 years ago

Interventions

Ociperlimabdrug

Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle

Tislelizumabdrug

Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle

Concurrent Chemoradiotherapydrug

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)