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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663205
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE July 23, 2018
Estimated Primary Completion Date June 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
Progression Free Survival (PFS) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Objective Response Rate (ORR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  • Duration Of Response (DOR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  • Overall Survival [ Time Frame: approximately 3 years ]
  • Progression Free Survival (PFS) as assessed by the investigator [ Time Frame: approximately 2 years ]
  • Objective response rate (ORR) as assessed by the investigator [ Time Frame: approximately 2 years ]
  • Duration of response (DOR) as assessed by the investigator [ Time Frame: 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 patient-reported outcomes [ Time Frame: 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
  • 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 patient-reported outcomes [ Time Frame: 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.
  • 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 ]
  • PD-L1 expression by IHC [ Time Frame: approximately 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • Objective Response Rate (ORR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  • Duration Of Response (DOR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  • Overall Survival [ Time Frame: approximately 2 years ]
  • Progression Free Survival (PFS) as assessed by the investigator [ Time Frame: approximately 2 years ]
  • Objective response rate (ORR) as assessed by the investigator [ Time Frame: approximately 2 years ]
  • Duration of response (DOR) as assessed by the investigator [ Time Frame: 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 patient-reported outcomes [ Time Frame: 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
  • 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 patient-reported outcomes [ Time Frame: 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.
  • 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 ]
  • PD-L1 expression by IHC [ Time Frame: approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous NSCLC
Official Title  ICMJE 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)
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 Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer. 45 sites will be involved in China, 320 subjects will be enrolled.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
    Treatment for advanced NSCLC
  • Drug: Cisplatin or Carboplatin,Pemetrexed
    Treatment for advanced NSCLC
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed
  • Active Comparator: Cisplatin or Carboplatin and Pemetrexed
    Intervention: Drug: Cisplatin or Carboplatin,Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 23, 2019)
334
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
320
Estimated Study Completion Date  ICMJE September 23, 2020
Estimated Primary Completion Date June 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Patients must have ≥ 1 measurable lesion as defined per RECIST v1.1
  5. Patient must have no prior systemic chemotherapy for advanced or metastatic Non-Squamous NSCLC
  6. Life expectancy ≥ 12 weeks
  7. Patients 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. Sever infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  8. Any major surgical procedure ≤ 28 days before randomization
  9. HIV infection
  10. Patient with untreated HBV/HCV.
  11. Active autoimmune diseases or history of autoimmune diseases
  12. History of allergic reactions to chemotherapy ……..
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663205
Other Study ID Numbers  ICMJE BGB-A317-304
CTR20180032 ( Registry Identifier: Center for drug evaluation, CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shun Lu, MD Shanghai Chest Hospital
PRS Account BeiGene
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP