A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase III Open Label First Line Therapy Study of Tislelizumab With Chemotherapy Versus Chemotherapy in Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer(NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663205
• Other study ID #: BGB-A317-304
• Secondary ID: CTR20180032
• Status: Completed
• Phase: Phase 3
• Start date: July 23, 2018
• Est. completion date: April 26, 2023

Study information

• Verified date: May 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 3, Open-Label, Multi-Center, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Participants With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: April 26, 2023
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years old, male or female, signed ICF

2. Advanced NSCLC diagnosed by pathological or clinical physicians

3. ECOG PS = 1

4. Participants must have = 1 measurable lesion as defined per RECIST v1.1

5. Participants must have no prior systemic chemotherapy for advanced or metastatic non-squamous NSCLC

6. Life expectancy = 12 weeks

7. Participants must have adequate organ function

8. Male/Female is willing to use a highly effective method of birth control

Exclusion Criteria:

1. Diagnosed with NSCLC but with EGFR-sensitizing mutation or ALK gene translocation

2. Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment

3. Received prior treatment with EGFR inhibitors or ALK inhibitors

4. Received prior therapies targeting PD-1 or PD-L1

5. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases

6. Clinically significant pericardial effusion

7. Severe infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis

8. Any major surgical procedure = 28 days before randomization

9. HIV infection

10. Participants with untreated HBV/HCV

11. Active autoimmune diseases or history of autoimmune diseases

12. History of allergic reactions to chemotherapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
Treatment for advanced NSCLC
• Cisplatin or Carboplatin,Pemetrexed
Treatment for advanced NSCLC

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	The second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Third Affiliated Hospital (Institute of Field Surgery) of PLA Army Medical University	Chongqing	Chongqing
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangzhou
China	Nanfang Hospital,Southern Medical University	Guangzhou	Guangzhou
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	Hainan General Hospital	Haikou	Hainan
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Weifang People's Hospital	Huaifang	Shandong
China	Jinan Central Hospital	Jinan	Shandong
China	Jinan Military General Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	Yunnan Cancer Hospital, &The Third Affiliated Hospital of Kunming Medical University&Yunnan Cancer Center &Yunnan Cancer Center	Kunming	Yunnan
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The People's Hospital Of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Fudan Universuty Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Cancer Hospital Of Shantou University Medical College	Shantou	Guangdong
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	General Hospital, Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	the First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) assessed by Independent Review Committee(IRC)		approximately 2 years
Secondary	Objective Response Rate (ORR) assessed by Independent Review Committee(IRC)		approximately 2 years
Secondary	Duration Of Response (DOR) assessed by Independent Review Committee(IRC)		approximately 2 years
Secondary	Overall Survival		approximately 3 years
Secondary	Progression Free Survival (PFS) as assessed by the investigator		approximately 2 years
Secondary	Objective response rate (ORR) as assessed by the investigator		approximately 2 years
Secondary	Duration of response (DOR) as assessed by the investigator		approximately 2 years
Secondary	health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ LC13) as presented in participants-reported outcomes	Scale construct including to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis; each item with range of maximum scores 4 as worse outcome and minimum scores 1 as higher values represent a better	approximately 2 years
Secondary	health-related quality of life (HRQoL)- measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Core 30 (EORTC QLQ-C30) as presented in participants-reported outcomes	Scale construct including to assess Global health status/QoL with range from minimum scores 1 as worse outcome and maximum scores 7 as higher values represent a better; Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning, Fatigue, Nausea and vomiting, Pain Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea and Financial difficulties with range from maximum scores 4 as worse outcome and from minimum scores 1 as higher values represent a better.	approximately 2 years
Secondary	Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03		approximately 2 years
Secondary	PD-L1 expression by IHC		approximately 2 years