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

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)

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.

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed; Drug: Cisplatin or Carboplatin,Pemetrexed

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100039
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100005
      • Beijing Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China, 400038
      • The Third Affiliated Hospital (Institute of Field Surgery) of PLA Army Medical University
    • Chongqing, Chongqing, China, 404199
      • Chongqing Three Gorges Central Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital
    • Xiamen, Fujian, China, 361003
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
  • Guangxi
    • Guilin, Guangxi, China, 541001
      • Affiliated Hospital of Guilin Medical University
    • Nanning, Guangxi, China, 530021
      • The People's Hospital of Guangxi Zhuang Autonomous Region
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510515
      • Nanfang Hospital，Southern Medical University
    • Guangzhou, Guangzhou, China, 510095
      • Cancer Center of Guangzhou Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • Guizhou Cancer Hospital
    • Zunyi, Guizhou, China, 563099
      • Affiliated Hospital of Zunyi Medical College
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410018
      • Changsha Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • the First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning cancer hospital
  • Shandong
    • Huaifang, Shandong, China, 261599
      • Weifang People's Hospital
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
    • Jinan, Shandong, China, 250031
      • Jinan Military General Hospital
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital
    • Shanghai, Shanghai, China, 200032
      • Fudan Universuty Shanghai Cancer Center
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital,Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute & Hospital
    • Tianjin, Tianjin, China, 300052
      • General Hospital, Tianjin Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital, &The Third Affiliated Hospital of Kunming Medical University&Yunnan Cancer Center &Yunnan Cancer Center
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of Medical School of Zhejiang University
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab combined with Platinum and Pemetrexed; 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.	Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed; Treatment for advanced NSCLC
Active Comparator: Cisplatin or Carboplatin and Pemetrexed	Drug: Cisplatin or Carboplatin,Pemetrexed; Treatment for advanced NSCLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival (PFS) assessed by Independent Review Committee(IRC)	approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) assessed by Independent Review Committee(IRC)		approximately 2 years
Duration Of Response (DOR) assessed by Independent Review Committee(IRC)		approximately 2 years
Overall Survival		approximately 3 years
Progression Free Survival (PFS) as assessed by the investigator		approximately 2 years
Objective response rate (ORR) as assessed by the investigator		approximately 2 years
Duration of response (DOR) as assessed by the investigator		approximately 2 years
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
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
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
PD-L1 expression by IHC		approximately 2 years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: Shun Lu, MD, Shanghai Chest Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Folic Acid Antagonists; Carboplatin; Cisplatin; Pemetrexed; Tislelizumab
• Other Study ID Numbers: BGB-A317-304; CTR20180032 (Registry Identifier: Center for drug evaluation, CFDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No