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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 : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Tislelizumab,Cisplatin or Carboplatin ,Pemetrexed Drug: Cisplatin or Carboplatin,Pemetrexed Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : July 23, 2018
Estimated Primary Completion Date : June 21, 2020
Estimated Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. Progression Free Survival (PFS) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  2. Duration Of Response (DOR) assessed by Independent Review Committee(IRC) [ Time Frame: approximately 2 years ]
  3. Overall Survival [ Time Frame: approximately 3 years ]
  4. Progression Free Survival (PFS) as assessed by the investigator [ Time Frame: approximately 2 years ]
  5. Objective response rate (ORR) as assessed by the investigator [ Time Frame: approximately 2 years ]
  6. Duration of response (DOR) as assessed by the investigator [ Time Frame: 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 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

  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 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.

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ……..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663205


  Show 49 Study Locations
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03663205     History of Changes
Other Study ID Numbers: BGB-A317-304
CTR20180032 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors