Comparison of Efficacy and Safety of Anti-PD-1 Antibody BGB-A317 Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358875
• Other study ID #: BGB-A317-303
• Secondary ID: 2018-000245-39CT
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2017
• Est. completion date: January 18, 2024

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show that BGB-A317 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: January 18, 2024
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Age18 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 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

Key Exclusion Criteria:

1. Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.

2. Harboring EGFR sensitizing mutation or ALK gene translocation.

3. Unresolved side effects of Grade 2 and above from prior anti-cancer therapies, except for AEs not constituting a likely safety risk (e.g. alopecia, rash, pigmentation, specific lab abnormalities).

4. History of severe hypersensitivity reactions to other 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 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tislelizumab
Intravenous injection (Anti-PD-1 monoclonal antibody)
• Docetaxel
Intravenous injection (Antineoplastic, cytotoxic, taxane)

Locations

Country	Name	City	State
Brazil	Hospital de Câncer de Barretos - Fundação Pio XII	Barretos	Sao Paulo
Brazil	Hospital Evangélico de Cachoeiro de Itapemirim	Cachoeiro De Itapemirim	Espírito Santo
Brazil	Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará	Fortaleza	Ceará
Brazil	Hospital de Caridade de Ijuí	Ijuí	Rio Grande Do Sul
Brazil	Fundação Doutor Amaral Carvalho	Jaú	Sao Paulo
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	INCA - Instituto Nacional de Câncer	Rio De Janeiro	Rio De Janiero
Brazil	NOB - Núcleo de Oncologia da Bahia	Salvador	Bahia
Brazil	CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia	Santo Andre	Sao Paulo
Brazil	Fundação Faculdade Regional de Medicina de São José do Rio Preto	São José do Rio Preto	Sao Paulo
Brazil	ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira	São Paulo	Sao Paulo
Bulgaria	MHAT "Dr. Tota Venkova", AD	Gabrovo
Bulgaria	Acibadem City Clinic Tokuda Hospital Ead	Sofia
China	Beijing Cancer Hospital	Beijin	Beijing
China	Beijing Chest Hospital, Capital Medical University	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences City: Beijing	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha	Hunan
China	Hunan Cancer Hospital	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Daping Hospital of The 3rd Military University	Chongqing	Chongqing
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	Guangzhou Institute of Respiratory	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Linyi Cancer Hospital	Linyi	Shandong
China	Jiangxi cancer hospital	Nanchang	Jiangxi
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Ruijin hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Second Hospital Affiliated to Suzhou University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Hubei cancer hospital	Wuhan	Hubei
China	Tongji Hospital of Tongji Medical College Huazhong University of Science Technology	Wuhan
China	First Affiliated Hospital of Xi'an Jiaotong University	Xian	Shanxi
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics branch Oncology Hospital	Kaunas
Lithuania	National Cancer Institute	Vilnius
Mexico	Investigacion Onco Farmaceutica (OncoTech)	La Paz	Baja California Sur
Mexico	Fundacion Rodolfo Padilla Padilla, A.C.	León	Guanajuato
Mexico	Health Pharma Professional Research S.A. de C.V.	Mexico	Distrito Federal
Mexico	Accelerium S de RL de CV	Monterrey	Nuevo León
New Zealand	Auckland City Hospital	Grafton
New Zealand	Waikato Hospital	Hamilton
New Zealand	Tauranga Hospital	Tauranga
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna	Lódz
Poland	SP Zespol Gruzlicy i Chorob Pluc w Olsztynie	Olsztyn
Russian Federation	SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"	Arkhangel'sk
Russian Federation	Irkutsk Regional Oncology Dispensary	Irkutsk
Russian Federation	"VitaMed" LLC	Moscow
Russian Federation	FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"	Moscow
Russian Federation	BHI of Omsk region "Clinical Oncology Dispensary"	Omsk
Russian Federation	Pavlov First Saint Petersburg State Medical University	Saint Petersburg
Russian Federation	Private Medical Institution "Evromedservis"	Saint Petersburg
Russian Federation	FSBI of higher education"Ogarev Mordovia State University"	Saransk
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta	Banska Bystrica
Slovakia	Nemocnica na okraji mesta, n.o.	Partizanske
Slovakia	POKO Poprad s.r.o.	Poprad
Turkey	Acibadem Adana Hospital	Adana
Turkey	Hacettepe University	Ankara
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital	Istanbul
Turkey	Istanbul Medeniyet Uni Goztepe Training&Res Hosp	Istanbul
Turkey	Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty	Istanbul
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Inonu Uni. Med. Fac.	Malatya
Turkey	Namik Kemal University	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

Brazil,  Bulgaria,  China,  Lithuania,  Mexico,  New Zealand,  Poland,  Russian Federation,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint)		Up to 31 months
Secondary	Objective response rate(ORR)		Up to 31 months
Secondary	Duration of response (DOR)		Up to 31 months
Secondary	Progression-free survival (PFS)		Up to 31 months
Secondary	Health-related Quality of Life (HRQoL)		Up to 31 months
Secondary	Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.		Up to 31 months