Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Registration Number
- NCT04921358
- Lead Sponsor
- BeiGene
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 377
- Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
- Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
- No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
- Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
- No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
- At least 1 measurable lesion as defined based on RECIST v1.1 by investigator
Key
- Has received docetaxel as monotherapy or in combination with other therapies.
- Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
- Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
- Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Tislelizumab in combination with Sitravatinib Sitravatinib tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day Arm A: Tislelizumab in combination with Sitravatinib Tislelizumab tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day Arm B: Docetaxel Docetaxel docetaxel 75 mg/m2 intravenously once every 3 weeks
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) From first randomization up to 35 months, approximately defined as the time from randomization to the first occurrence of disease progression as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first
Overall survival (OS) From first randomization up to 35 months, approximately OS is defined as the time from randomization to the date of death due to any reason.
- Secondary Outcome Measures
Name Time Method Health-related quality of life (HRQoL) as assessed according to the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30) From first randomization up to 35 months, approximately The EORTC QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Duration of Response (DOR) From first randomization up to 35 months, approximately defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first
Progression-free survival (PFS) From first randomization up to 35 months, approximately defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
Overall response rate (ORR) From first randomization up to 35 months, approximately defined as the proportion of participants with partial response or complete response as determined by the IRC based on RECIST v1.1
Disease control rate (DCR) From first randomization up to 35 months, approximately defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by the IRC based on RECIST v1.1
Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13 From first randomization up to 35 months, approximately A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
Health-related quality of life (HRQoL) as assessed according to the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) From first randomization up to 35 months, approximately Participant-reported outcomes based on EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) for all cohorts The EQ-5D- is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system has two versions, namely the 3L and 5L, both involving five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following five response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.
Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 From first randomization up to 35 months, approximately Plasma concentration of sitravatinib From first randomization up to 35 months, approximately
Trial Locations
- Locations (63)
Xinqiao Hospital Affiliated to the Army Medical University
🇨🇳Chongqing, Chongqing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The Northern Hospital
🇦🇺Epping, Victoria, Australia
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
🇨🇳Hefei, Anhui, China
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Peoples Hospital of Chenzhou
🇨🇳Chenzhou, Hunan, China
The Second Hospital, University of South China
🇨🇳Hengyang, Hunan, China
Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
🇨🇳Changzhou, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
🇨🇳Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Liaoning Cancer Hospital and Institute
🇨🇳Shenyang, Liaoning, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
The Affiliated Hospital of Qingdao University Branch Laoshan
🇨🇳Qingdao, Shandong, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Huashan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Sichuan Cancer Hospital and Institute
🇨🇳Chengdu, Sichuan, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
Cancer Research South Australia
🇦🇺Adelaide, South Australia, Australia
Blacktown Cancer and Haematology Centre
🇦🇺Blacktown, New South Wales, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
Pindara Private Hospital
🇦🇺Benowa, Queensland, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
The Tumor Hospital Affiliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Cancer Hospital Chinse Academy of Medical Sciences, Shenzhen Center
🇨🇳Shenzhen, Guangdong, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang
🇨🇳Taizhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China