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

Sponsor
BeiGene (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03663205
Collaborator
(none)
334
Enrollment
49
Locations
2
Arms
55.2
Anticipated Duration (Months)
6.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
  • Drug: Cisplatin or Carboplatin,Pemetrexed
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
334 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 23, 2018
Actual Primary Completion Date :
Oct 26, 2020
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival (PFS) assessed by Independent Review Committee(IRC) [approximately 2 years]

Secondary Outcome Measures

  1. Objective Response Rate (ORR) assessed by Independent Review Committee(IRC) [approximately 2 years]

  2. Duration Of Response (DOR) assessed by Independent Review Committee(IRC) [approximately 2 years]

  3. Overall Survival [approximately 3 years]

  4. Progression Free Survival (PFS) as assessed by the investigator [approximately 2 years]

  5. Objective response rate (ORR) as assessed by the investigator [approximately 2 years]

  6. Duration of response (DOR) as assessed by the investigator [approximately 2 years]

  7. 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 [approximately 2 years]

    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

  8. 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 [approximately 2 years]

    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.

  9. 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]

  10. PD-L1 expression by IHC [approximately 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Provincial Hospital Hefei Anhui China 230001
2 Beijing Hospital Beijing Beijing China 100005
3 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China 100021
4 Peking Union Medical College Hospital Beijing Beijing China 100032
5 Chinese PLA General Hospital Beijing Beijing China 100039
6 Beijing Cancer Hospital Beijing Beijing China 100142
7 The second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
8 The Third Affiliated Hospital (Institute of Field Surgery) of PLA Army Medical University Chongqing Chongqing China 400038
9 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404199
10 Fujian Provincial Cancer Hospital Fuzhou Fujian China 350014
11 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
12 Cancer Hospital Of Shantou University Medical College Shantou Guangdong China 515031
13 Affiliated Hospital of Guilin Medical University Guilin Guangxi China 541001
14 The People's Hospital Of Guangxi Zhuang Autonomous Region Nanning Guangxi China 530021
15 Cancer Center of Guangzhou Medical University Guangzhou Guangzhou China 510095
16 Nanfang Hospital,Southern Medical University Guangzhou Guangzhou China 510515
17 Guizhou Cancer Hospital Guiyang Guizhou China 550000
18 Affiliated Hospital of Zunyi Medical College Zunyi Guizhou China 563099
19 Hainan General Hospital Haikou Hainan China 570311
20 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
21 Henan Cancer Hospital Zhengzhou Henan China 450008
22 the First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
23 Hubei Cancer Hospital Wuhan Hubei China 430079
24 Hunan Cancer Hospital Changsha Hunan China 410000
25 Changsha Central Hospital Changsha Hunan China 410018
26 Jiangsu Province Hospital Nanjing Jiangsu China 210029
27 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
28 Xuzhou Central Hospital Xuzhou Jiangsu China 221009
29 The First Hospital of Jilin University Changchun Jilin China 130021
30 The First Hospital of China Medical University Shenyang Liaoning China 110001
31 Liaoning Cancer Hospital Shenyang Liaoning China 110042
32 Weifang People's Hospital Huaifang Shandong China 261599
33 Qilu Hospital of Shandong University Jinan Shandong China 250012
34 Jinan Central Hospital Jinan Shandong China 250013
35 Jinan Military General Hospital Jinan Shandong China 250031
36 Shandong Cancer Hospital Jinan Shandong China 250117
37 Shanghai Chest Hospital Shanghai Shanghai China 200030
38 Fudan Universuty Shanghai Cancer Center Shanghai Shanghai China 200032
39 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi China 710061
40 West China Hospital,Sichuan University Chengdu Sichuan China 610041
41 General Hospital, Tianjin Medical University Tianjin Tianjin China 300052
42 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China 300060
43 Yunnan Cancer Hospital, &The Third Affiliated Hospital of Kunming Medical University&Yunnan Cancer Center &Yunnan Cancer Center Kunming Yunnan China 650118
44 The First Affiliated Hospital of Medical School of Zhejiang University Hangzhou Zhejiang China 310003
45 Hangzhou First People's Hospital Hangzhou Zhejiang China 310006
46 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
47 Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang China 310016
48 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
49 Shanghai Chest Hospital Shanghai China

Sponsors and Collaborators

  • BeiGene

Investigators

  • Principal Investigator: Shun Lu, MD, Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT03663205
Other Study ID Numbers:
  • BGB-A317-304
  • CTR20180032
First Posted:
Sep 10, 2018
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cisplatin
Carboplatin
Pemetrexed

Study Results

No Results Posted as of Aug 9, 2022