A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer

PHASE3TerminatedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

June 17, 2021

Primary Completion Date

October 17, 2023

Study Completion Date

October 17, 2023

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Tislelizumab

200 mg intravenously every three weeks

DRUG

Durvalumab

10 milligrams per kilogram (mg/kg) intravenously once every 2 weeks (or 1500 mg intravenously once every 4 weeks where the dosage has been approved by a local health authority)

DRUG

Ociperlimab

900 milligrams (mg) intravenously every three weeks

DRUG

Chemotherapy

"The chemotherapy regimen for the study treatment was selected at the investigator's discretion and may include one of the following options:~* Cisplatin (50 mg/m²) on days 1 to 5 of each cycle, combined with etoposide (50 mg/m²) on days 1 and 8, both administered intravenously for 2 cycles. Each cycle was 28 days.~* Carboplatin (AUC 2) weekly for 6 weeks, combined with paclitaxel (40-50 mg/m²) weekly for 6 weeks, both administered intravenously.~* Cisplatin (75 mg/m²) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days.~* Carboplatin (AUC 5) combined with pemetrexed (500 mg/m²) on day 1 of each cycle, administered intravenously for 2 cycles. Each cycle was 21 days.~The pemetrexed plus platinum regimen was only for participants with non-squamous histology."

RADIATION

Radiotherapy

All participants recieved radiotherapy using either a standardized 3-dimensional conformal radiotherapy technique, or intensity modulated radiotherapy (IMRT) on a linear accelerator delivering a beam energy of ≥ 6 MV. The total dose of radiotherapy was 60 Gy, administered in 30 once-daily fractions of 2 Gy and 5 fractions per week for 6 weeks.

Trial Locations (35)

3144

Cabrini Hospital, Malvern

4215

Gold Coast University Hospital, Gold Coast

4814

Townsville Hospital, Douglas

5112

Lyell McEwin Hospital, Elizabeth Vale

11217

Taipei Veterans General Hospital, Taipei

17007

Ico Girona, Girona

28040

Hospital Universitario Fundación Jiménez Díaz, Alcorcón

40201

Chung Shan Medical University Hospital, Taichung

50006

Changhua Christian Hospital, Changhua

65613

XCancer/Centeral Care Center, Bolivar

100142

Beijing Cancer Hospital, Beijing

130021

Jilin Cancer Hospital, Changchun

The First Hospital of Jilin University, Changchun

200000

Fudan University Shanghai Cancer Center, Shanghai

210009

Nanjing First Hospital, Nanjing

213000

Changzhou Cancer Hospital, Changzhou

215006

The First Affiliated Hospital of Soochow University Branch Shizi, Suzhou

250117

Shandong Cancer Hospital and Institute, Shandong First Medical University, Jinan

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310016

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou

330006

The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang

350014

Fujian Cancer Hospital, Fuzhou

400030

Chongqing University Cancer Hospital, Chongqing

410013

Hunan Cancer Hospital - GCP Office, Changsha

510515

Nanfang Hospital of Southern Medical University, Guangzhou

522091

Jieyang People'S Hospital (Jieyang Affiliated Hospital, Sun Yat-Sen University ), Jieyang

610041

West China Hospital, Sichuan University, Chengdu

750004

General Hospital of Ningxia Medical University, Yinchuan

NSW 2500

Southern Medical Day Care Centre, Wollongong

Unknown

Royal Hobart Hospital, Hobart

Hollywood Private Hospital, Perth

The First Affiliated Hospital, Sun Yat-sen University, Guangzhou

Peking University Third Hospital, Beijing

Taichung Veterans General Hospital, Taichung

08028

Instituto Oncologico Dr. Rosell, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY

NCT04866017 - A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter