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A Study Evaluating the Effica...

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

Last Updated: 2025-02-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-23

Study Completion Date

2023-04-26

Brief Summary

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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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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tislelizumab + Platinum + Pemetrexed

Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered intravenously

Cisplatin

Intervention Type DRUG

Administered intravenously

Carboplatin

Intervention Type DRUG

Administered intravenously

Pemetrexed

Intervention Type DRUG

Administered intravenously

Platinum + Pemetrexed

Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Administered intravenously

Carboplatin

Intervention Type DRUG

Administered intravenously

Pemetrexed

Intervention Type DRUG

Administered intravenously

Interventions

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Tislelizumab

Administered intravenously

Intervention Type DRUG

Cisplatin

Administered intravenously

Intervention Type DRUG

Carboplatin

Administered intravenously

Intervention Type DRUG

Pemetrexed

Administered intravenously

Intervention Type DRUG

Other Intervention Names

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Tevimbra BGB-A317

Eligibility Criteria

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Inclusion Criteria

1. Age 18-75 years old, male or female, signed informed consent form
2. Advanced NSCLC diagnosed by pathological or clinical physicians
3. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
4. Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
5. Participants must have no prior systemic chemotherapy for advanced or metastatic 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

Exclusion Criteria

1. Diagnosed with NSCLC but with epidermal growth factor receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (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 programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
5. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
6. Clinically significant pericardial effusion
7. Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
8. Any major surgical procedure ≤ 28 days before randomization
9. Human immunodeficiency virus (HIV) infection
10. Participants with untreated hepatitis B or C virus (HBV/HCV)
11. Active autoimmune diseases or history of autoimmune diseases
12. History of allergic reactions to chemotherapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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