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

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ClinicalTrials.gov Identifier: NCT03594747
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

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 subjects 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Open Label Study of Tislelizumab Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First-line Treatment in Stage IIIB/IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




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 patients 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 [ Time Frame: 2 years or more ]
    To compare OS between tislelizumab combined with paclitaxel + carboplatin or nab-paclitaxel + carboplatin and paclitaxel + carboplatin alone



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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. Must be treatment-naive for locally advanced or metastatic 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 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. 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): NCT03594747


Contacts
Contact: Wenliang Chen 86-10-8567 9808 clinicaltrails@beigene.com

Locations
China
Cancer Hospital of the medical academy Not yet recruiting
Beijing, China
Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03594747     History of Changes
Other Study ID Numbers: BGB-A317-307
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action