Skip to main content
OpenTrials
Completed

NCT Number: NCT03594747

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

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 non-small cell lung cancer (NSCLC).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Age 18-75 years old, male or female, and signed informed consent form (ICF)
  • Advanced NSCLC diagnosed by pathological or clinical physicians
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
  • Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Must be treatment-naive for locally advanced or metastatic squamous NSCLC
  • Life expectancy ≥ 12 weeks
  • Participants must have adequate organ function
  • Male/Female is willing to use a highly effective method of birth control

Key Exclusion Criteria:

  • Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
  • Received any approved systemic anticancer therapy
  • Received prior treatment with EGFR inhibitors or ALK inhibitors
  • Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
  • With history of interstitial lung disease
  • Clinically significant pericardial effusion
  • Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any major surgical procedure before randomization
  • Human immunodeficiency virus infection
  • Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
  • Active autoimmune diseases or history of autoimmune diseases
  • History of allergic reactions to chemotherapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Tislelizumab

Drug

Administered intravenously as described

Other names: BGB-A317, Tevimbra

paclitaxel

Drug

Administered intravenously as described

Nab-paclitaxel

Drug

Administered intravenously as described

carboplatin

Drug

Administered intravenously as described

Primary outcomes

  1. Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019

    Time frame: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first

  2. PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020

    Time frame: Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months)

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    OS is defined as the time from randomization until the date of death due to any cause

  2. Objective Response Rate (ORR) by IRC Assessment

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1.

  3. ORR by Investigator Assessment

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1.

  4. Duration of Response (DOR) by IRC Assessment

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

  5. DOR by Investigator Assessment

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

  6. PFS by Investigator Assessment

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first

  7. PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression

    Time frame: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells

  8. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)

    Time frame: Baseline to Cycle 5; each cycle is 21 days

    Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.

  9. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

    Time frame: Baseline to Cycle 5; each cycle is 21 days

    Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

  10. Number of Participants With Adverse Events

    Time frame: From first dose to 30 days after the last dose (up to approximately 4 years and 9 months)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Jul 20, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.