A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
NCT ID: NCT04866017
Last Updated: 2024-10-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
63 participants
INTERVENTIONAL
2021-06-17
2023-10-17
Brief Summary
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Detailed Description
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After implementation of PA 2, participants who were randomized under PA 1 were given the option to continue assigned study treatment or to discontinue assigned treatment and begin standard of care treatment outside of the study. Participants enrolled under PA 1 were excluded from the primary and secondary analysis specified by PA 2.
This study was subsequently terminated by the Sponsor prior to enrollment of any participants under PA 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ociperlimab + Tislelizumab + cCRT
Participants enrolled under PA1 recieved two cycles of ociperlimab combined with tislelizumab and cCRT, followed by ociperlimab combined with tislelizumab up to 1 year after the cCRT phase
Tislelizumab
200 mg intravenously every three weeks
Ociperlimab
900 milligrams (mg) intravenously every three weeks
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.
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.
Tislelizumab + cCRT
Participants enrolled under PA1 recieved two cycles of tislelizumab combined with cCRT, followed by tislelizumab up to 1 year after the cCRT phase
Tislelizumab
200 mg intravenously every three weeks
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.
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.
cCRT followed by Durvalumab
Participants enrolled under PA1 recieved two cycles of cCRT, followed by durvalumab to 1 year after the cCRT phase
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)
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.
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.
Interventions
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Tislelizumab
200 mg intravenously every three weeks
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)
Ociperlimab
900 milligrams (mg) intravenously every three weeks
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
3. Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
4. Participants must have not experienced PD following definitive, platinum-based cCRT.
5. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Participants must have adequate organ function
7. Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor \[preferred\] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy obtained prior to cCRT (if archival tissue is not available) for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers.
Exclusion Criteria
2. Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
3. Participants who received systemic anticancer treatment besides the specified cCRT.
4. Any unresolved toxicity CTCAE \> Grade 2 from the prior cCRT.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse.
6. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone \[in Japan, prednisolone\] or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
7. Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.
Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Locations
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Cabrini Hospital
Malvern, Victoria, Australia
Gold Coast University Hospital
Gold Coast, , Australia
Hollywood Private Hospital
Perth, , Australia
Fujian Cancer Hospital
Fuzhou, Fujian, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
XCancer/Centeral Care Center
Bolivar, Missouri, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Townsville Hospital
Douglas, Queensland, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hunan Cancer Hospital - GCP Office
Changsha, Hunan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shandong Cancer Hospital and Institute, Shandong First Medical University
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Peking University Third Hospital
Beijing, , China
Changzhou Cancer Hospital
Changzhou, , China
Jieyang People'S Hospital (Jieyang Affiliated Hospital, Sun Yat-Sen University )
Jieyang, , China
Hospital Universitario Fundación Jiménez Díaz
Alcorcón, Madrid, Spain
Instituto Oncologico Dr. Rosell
Barcelona, , Spain
Ico Girona
Girona, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-004656-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AdvanTIG-301
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-A1217-301
Identifier Type: -
Identifier Source: org_study_id
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