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Comparison of Efficacy and Sa...

Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC)

Last Updated: 2025-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

805 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2024-01-18

Brief Summary

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The purpose of this study is to show that tislelizumab will improve overall survival in participants with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.

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Detailed Description

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This is a randomized, open-label, multicenter Phase 3 study in adult participants with histologically confirmed, locally advanced or metastatic (Stage IIIB or IV), NSCLC (squamous or non-squamous) who have disease progression during or after a platinum-containing regimen.

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

Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab administered by intravenous (IV) infusion

Docetaxel

Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel administered as an IV infusion over 1 hour

Interventions

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Tislelizumab

Tislelizumab administered by intravenous (IV) infusion

Intervention Type DRUG

Docetaxel

Docetaxel administered as an IV infusion over 1 hour

Intervention Type DRUG

Other Intervention Names

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BGB-A317 TEVIMBRA®

Eligibility Criteria

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Inclusion Criteria

1. Age ≥ 18 years.
2. Signed Informed Consent Form.
3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC of either squamous or non-squamous histology types with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy.
4. Participants must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells. Participants with non-squamous histology must provide evidence of not harboring sensitizing epidermal growth factor (EGFR) mutation tested by a histology-based method.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
6. Adequate hematologic and end-organ function.
7. Expected life span \> 12 weeks.
8. Willing to be compliance with birth control requirement during pre-specified study participating period

Exclusion Criteria

1. Prior therapies of docetaxel or treatment targeting programmed cell death protein 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte associated protein 4 (CTLA-4).
2. Harboring EGFR sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation.
3. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for adverse events (AEs) not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).
4. History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).
5. History of interstitial lung disease, non-infectious pneumonitis or participants with significantly impaired pulmonary function, or who require supplemental oxygen at baseline.
6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
7. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
8. Severe chronic or active infection requiring systemic treatment.
9. Known human immunodeficiency virus (HIV) infection, participants with untreated chronic hepatitis B, active vaccination treatment.
10. Insufficient cardiac functions and other underlying unfavorable cardiovascular conditions.
11. Prior allogeneic stem cell transplantation or organ transplantation.
12. Active autoimmune diseases or history of autoimmune diseases that may relapse.
13. With conditions requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone or equivalent) or other immunosuppressive medications.
14. With severe underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse that may affect the explanation of drug toxicity or AEs or result in impaired compliance with study conduct.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caicun Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

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Hospital de Amor Barretos

Barretos, , Brazil

Site Status

Hospital Evangelico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, , Brazil

Site Status

Hospital Haroldo Juacaba Instituto Do Cancer Do Ceara

Fortaleza, , Brazil

Site Status

Oncosite Centro de Pesquisa Clinica Em Oncologia

Ijuí, , Brazil

Site Status

Fundacao Doutor Amaral Carvalho

Jaú, , Brazil

Site Status

Hospital Bruno Born

Lajeado, , Brazil

Site Status

Hospital Sao Vicente de Paulo

Passo Fundo, , Brazil

Site Status

Hgb Hospital Giovanni Battista Mae de Deus Center

Porto Alegre, , Brazil

Site Status

Hospital Sao Lucas Da Pucrs

Porto Alegre, , Brazil

Site Status

Hospital Nossa Senhora Da Conceicao

Porto Alegre, , Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto AlegreRS, , Brazil

Site Status

Inca Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Site Status

Nob Nucleo de Oncologia Da Bahia

Salvador, , Brazil

Site Status

Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia

Santo André, , Brazil

Site Status

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, , Brazil

Site Status

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, , Brazil

Site Status

Umhat Deva Maria, Eood

Burgas, , Bulgaria

Site Status

Mhat Dobrich, Ad

Dobrich, , Bulgaria

Site Status

Mhat Dr Tota Venkova, Ad

Gabrovo, , Bulgaria

Site Status

Complex Oncology Center Rousse Eood

Rousse, , Bulgaria

Site Status

Mhat For Womens Health Nadezhda, Ood

Sofia, , Bulgaria

Site Status

Acibadem City Clinic Mhat Tokuda Ead

Sofia, , Bulgaria

Site Status

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status