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

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04866017
• Other study ID #: BGB-A317-A1217-301
• Secondary ID: 2020-004656-14Ad
• Status: Terminated
• Phase: Phase 3
• Start date: June 17, 2021
• Est. completion date: October 17, 2023

Study information

• Verified date: January 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm C (Durvalumab) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in participants with stage III unresectable PD-L1-selected non-small cell lung cancer whose disease has not progressed after cCRT.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Age = 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).

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.

Key Exclusion Criteria:

1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.

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.

NOTE: Other protocol Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Tislelizumab
administered by intravenous infusion
• Durvalumab
administered by intravenous infusion
• Ociperlimab
administered by intravenous infusion

Locations

Country	Name	City	State
Australia	Townsville Hospital	Douglas	Queensland
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Gold Coast University Hospital	Gold Coast
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Hollywood Private Hospital	Perth
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital - GCP Office	Changsha	Hunan
China	Changzhou Cancer Hospital	Changzhou
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang
China	Jieyang People'S Hospital (Jieyang Affiliated Hospital, Sun Yat-Sen University )	Jieyang
China	Shandong Cancer Hospital and Institute, Shandong First Medical University	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University Branch Shizi	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United States	XCancer/Centeral Care Center	Bolivar	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as assessed by the Independent Review Committee (IRC)	Time from the date of randomization to the date of first documentation of disease progression assessed by the IRC per RECIST v1.1 or death, whichever occurs first	Up to 16 months
Secondary	Overall Survival (OS)	defined as the time from the date of randomization until the date of death due to any cause	Up to 16 months
Secondary	Overall Response Rate (ORR)	defined as the proportion of participant who achieve a complete response (CR) or partial response (PR) assessed by both the IRC and investigators per RECIST v1.1	Up to 16 months
Secondary	Duration of Response (DOR)	defined as the time from the first determination of a confirmed objective response assessed by both the IRC and investigators per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first	Up to 16 months
Secondary	Time to death or distant metastasis (TTDM) as assessed by the investigator	defined as the time from the date of randomization until the first date of distant metastasis assessed by both the IRC and investigators, or death. Distant metastasis is defined as any new lesion that is outside of the radiation field per RECIST v1.1 or proven by biopsy.	Up to 16 months
Secondary	Progression-Free Survival 2 (PFS2)	defined as the time from randomization to the disease progression after next line of treatment, or death from any cause, whichever occurs first	Up to 16 months
Secondary	Number of participants experiencing Adverse Events (AEs)	The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).	Up to 16 months
Secondary	Health Related Quality of Life (HRQoL) as assessed by European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)	The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.; The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.	Up to 16 months
Secondary	Health Related Quality of Life (HRQoL)as assessed by Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)	The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.	Up to 16 months
Secondary	Health Related Quality of Life (HRQoL) as assessed by European Quality of Life-5 Dimensions (EQ-5D-5L)	EQ-5D-5L - Is the EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the participant's health state.	Up to 16 months
Secondary	Serum concentration of ociperlimab		Up to 30 minutes postdose
Secondary	Serum concentration of tislelizumab		Up to 30 minutes postdose
Secondary	Immunogenic responses to BGB-A1217 as assessed by the detection of anti-drug antibodies (ADAs)		Up to 16 months
Secondary	Immunogenic responses to Tislelizumab as assessed by the detection of anti-drug antibodies (ADAs)		Up to 16 months
Secondary	Evaluate PD-L1 and TIGIT expression in archival and/or fresh tumor tissues	before study treatment or at disease progression/reoccurrence, and their association with clinical efficacy.	Up to 16 months