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A Study Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer.

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: NCT03594747
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced Squamous NSCLC. 45 sites will be involved in China, 342 participants will be enrolled.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Tislelizumab Carboplatin Paxlitaxel Drug: Tislelizumab Carboplatin Nab-paxlitaxel Drug: Carboplatin Paclitaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non Small Cell Lung Cancer
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : July 20, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Tislelizumab combined with carboplatin and paclitaxel
Tislelizumab will be administered at a dose of 200 mg intravenously (IV) Q3W. Carboplatin area under the plasma concentration (AUC) 5, D1 of each cycle, administrated as an IV infusion over 15 to 60 minutes, for 4 to 6 cycles Paclitaxel 175 mg/m2, D1 of each cycle, administered as an IV infusion over 1 to 3 hours, for 4 to 6 cycles
 Drug: Tislelizumab Carboplatin Paxlitaxel
Treatment for advanced NSCLC
Experimental: Tislelizumab combined with carboplatin and nab-paclitaxel
Tislelizumab will be administered at a dose of 200 mg intravenously (IV) Q3W. Carboplatin area under the plasma concentration (AUC) 5, D1 of each cycle, administrated as an IV infusion over 15 to 60 minutes, for 4 to 6 cycles Nab-paclitaxel 100 mg/m2, D1, D8, and D15 of each cycle, administered as an IV infusion over 30 minutes, for 4 to 6 cycles
 Drug: Tislelizumab Carboplatin Nab-paxlitaxel
Treatment for advanced NSCLC
Active Comparator: Carboplatin and paclitaxel
Carboplatin area under the plasma concentration (AUC) 5, D1 of each cycle, administrated as an IV infusion over 15 to 60 minutes, for 4 to 6 cycles Paclitaxel 175 mg/m2, D1 of each cycle, administered as an IV infusion over 1 to 3 hours, for 4 to 6 cycles
 Drug: Carboplatin Paclitaxel
Treatment for advanced squamous NSCLC


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 2 years ]
    To compare the PFS between tislelizumab either combined with paclitaxel + carboplatin (Arm A) or combined with nab-paclitaxel + carboplatin and paclitaxel + carboplatin alone in participants with untreated Stage IIIB or Stage IV squamous NSCLC


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 2 years ]
    To compare ORR between tislelizumab combined with paclitaxel + carboplatin or nab paclitaxel + carboplatin and paclitaxel + carboplatin alone.

  2. Duration Of Response (DOR) [ Time Frame: 2 years ]
    To compare duration of response (DOR) between tislelizumab combined with paclitaxel + carboplatin or carboplatin + nab-paclitaxel and paclitaxel + carboplatin alone.

  3. Overall Survival (OS) [ Time Frame: 2 years or more ]
    To compare OS between tislelizumab combined with paclitaxel + carboplatin or nab-paclitaxel + carboplatin and paclitaxel + carboplatin alone


Eligibility Criteria
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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

Key Inclusion Criteria:

  1. Age 18-75 years old, male or female, signed informed consent form (ICF).
  2. Advanced NSCLC diagnosed by pathological or clinical physicians
  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
  4. Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
  5. Must be treatment-naive for locally advanced or metastatic 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

Key Exclusion Criteria:

  1. Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or ALK gene translocation
  2. Received any approved systemic anticancer therapy
  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
  6. Clinically significant pericardial effusion
  7. Sever infections, Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  8. Any major surgical procedure before randomization
  9. HIV infection
  10. Participant with untreated hepatitis B virus (HBV)/hepatitis C virus (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
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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): NCT03594747


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Jie Wang, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03594747    
Other Study ID Numbers: BGB-A317-307
CTR20180292 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action