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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
Cisplatin or Carboplatin,Pemetrexed
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tislelizumab combined with Platinum and Pemetrexed

Cisplatin or Carboplatin and Pemetrexed

Arm Description

Tislelizumab will be administered at a dose of 200 mg intravenously (IV) Q3W. Cisplatin 75 mg/m2 administered as an intravenous (IV) infusion over 2 hours Q3W (every 3 weeks) for 4 to 6 cycles or Carboplatin AUC 5 administered as an IV infusion over 15 minutes Q3W for 4 to 6 cycles. Pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes Q3W.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) assessed by Independent Review Committee(IRC)

Secondary Outcome Measures

Objective Response Rate (ORR) assessed by Independent Review Committee(IRC)
Duration Of Response (DOR) assessed by Independent Review Committee(IRC)
Overall Survival
Progression Free Survival (PFS) as assessed by the investigator
Objective response rate (ORR) as assessed by the investigator
Duration of response (DOR) as assessed by the investigator
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
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.
Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03
PD-L1 expression by IHC

Full Information

First Posted
August 16, 2018
Last Updated
May 19, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03663205
Brief Title
A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
April 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab combined with Platinum and Pemetrexed
Arm Type
Experimental
Arm Description
Tislelizumab will be administered at a dose of 200 mg intravenously (IV) Q3W. Cisplatin 75 mg/m2 administered as an intravenous (IV) infusion over 2 hours Q3W (every 3 weeks) for 4 to 6 cycles or Carboplatin AUC 5 administered as an IV infusion over 15 minutes Q3W for 4 to 6 cycles. Pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes Q3W.
Arm Title
Cisplatin or Carboplatin and Pemetrexed
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
Intervention Description
Treatment for advanced NSCLC
Intervention Type
Drug
Intervention Name(s)
Cisplatin or Carboplatin,Pemetrexed
Intervention Description
Treatment for advanced NSCLC
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) assessed by Independent Review Committee(IRC)
Time Frame
approximately 2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) assessed by Independent Review Committee(IRC)
Time Frame
approximately 2 years
Title
Duration Of Response (DOR) assessed by Independent Review Committee(IRC)
Time Frame
approximately 2 years
Title
Overall Survival
Time Frame
approximately 3 years
Title
Progression Free Survival (PFS) as assessed by the investigator
Time Frame
approximately 2 years
Title
Objective response rate (ORR) as assessed by the investigator
Time Frame
approximately 2 years
Title
Duration of response (DOR) as assessed by the investigator
Time Frame
approximately 2 years
Title
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
Description
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
Time Frame
approximately 2 years
Title
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
Description
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.
Time Frame
approximately 2 years
Title
Incidence and severity of treatment-emergent AEs (TEAEs) graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.03
Time Frame
approximately 2 years
Title
PD-L1 expression by IHC
Time Frame
approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years old, male or female, signed ICF Advanced NSCLC diagnosed by pathological or clinical physicians ECOG PS ≤ 1 Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1 Participants must have no prior systemic chemotherapy for advanced or metastatic non-squamous NSCLC Life expectancy ≥ 12 weeks Participants must have adequate organ function Male/Female is willing to use a highly effective method of birth control Exclusion Criteria: Diagnosed with NSCLC but with EGFR-sensitizing mutation or ALK gene translocation Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment Received prior treatment with EGFR inhibitors or ALK inhibitors Received prior therapies targeting PD-1 or PD-L1 With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases Clinically significant pericardial effusion Severe infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis Any major surgical procedure ≤ 28 days before randomization HIV infection Participants with untreated HBV/HCV Active autoimmune diseases or history of autoimmune diseases History of allergic reactions to chemotherapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Lu, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
The Third Affiliated Hospital (Institute of Field Surgery) of PLA Army Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404199
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Cancer Hospital Of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
541001
Country
China
Facility Name
The People's Hospital Of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510095
Country
China
Facility Name
Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Guizhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Affiliated Hospital of Zunyi Medical College
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563099
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
the First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Changsha Central Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410018
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Weifang People's Hospital
City
Huaifang
State/Province
Shandong
ZIP/Postal Code
261599
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Jinan Military General Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan Universuty Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
General Hospital, Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Yunnan Cancer Hospital, &The Third Affiliated Hospital of Kunming Medical University&Yunnan Cancer Center &Yunnan Cancer Center
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35333492
Citation
Lu S, Yu Y, Barnes G, Qiu X, Bao Y, Tang B. Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. Cancer J. 2022 Mar-Apr 01;28(2):96-104. doi: 10.1097/PPO.0000000000000583.
Results Reference
derived

Learn more about this trial

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

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