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Completed

NCT Number: NCT03663205

A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer

This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).

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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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-75 years old, male or female, signed informed consent form
  • Advanced NSCLC diagnosed by pathological or clinical physicians
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
  • Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
  • Participants must have no prior systemic chemotherapy for advanced or metastatic NSCLC
  • Life expectancy ≥ 12 weeks
  • Participants must have adequate organ function
  • Male/female is willing to use a highly effective method of birth control

Exclusion criteria

  • Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
  • Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment
  • Received prior treatment with EGFR inhibitors or ALK inhibitors
  • Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
  • With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
  • Clinically significant pericardial effusion
  • Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any major surgical procedure ≤ 28 days before randomization
  • Human immunodeficiency virus (HIV) infection
  • Participants with untreated hepatitis B or C virus (HBV/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

Other names: Tevimbra, BGB-A317

Cisplatin

Drug

Administered intravenously

carboplatin

Drug

Administered intravenously

Pemetrexed

Drug

Administered intravenously

Primary outcomes

  1. Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment

    Time frame: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)

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

Secondary outcomes

  1. Objective Response Rate (ORR) by IRC Assessment

    Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

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

  2. Duration of Response (DOR) by IRC Assessment

    Time frame: Through study completion data cut-off date of 26APR2023 (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, or death from any cause, whichever comes first, as assessed by the IRC using RECIST v1.1 in participants with documented objective responses

  3. Overall Survival (OS)

    Time frame: Through study completion data cut-off date of 26APR2023 (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

  4. PFS by Investigator Assessment

    Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

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

  5. ORR by Investigator Assessment

    Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

    ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1

  6. DOR by Investigator Assessment

    Time frame: Through study completion data cut-off date of 26APR2023 (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, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses

  7. Change From Baseline in 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)

    Change from baseline in EORTC QLQ-CL13 scores for coughing, dyspnea, and chest pain . 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.

  8. Change From Baseline in 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)

    Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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.

  9. Number of Participants With Adverse Events

    Time frame: Through study completion data cut-off date of 26APR2023 (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

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

    Time frame: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 3, Open-Label, Multicenter, 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Sep 10, 2018
Registry last updated
Feb 4, 2025

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.

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