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

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Drug: Tislelizumab

• Registration Number: NCT03358875
• Lead Sponsor: BeiGene

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study Start: 2017-11-30
• Study First Posted: 2017-12-02
• Primary Completion: 2020-08-10
• Study Completion: 2024-01-18
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel	Docetaxel	75 mg/m2 IV Q3W
BGB-A317	Tislelizumab	100 mg per vial, 200mg intravenous (IV), Q3W

Primary Outcome Measures

Name	Time	Method
Overall survival (OS) in PD-L1+ and all participants (co-primary endpoint)	Up to 31 months

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life (HRQoL)	Up to 31 months
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03.	Up to 31 months
Objective response rate(ORR)	Up to 31 months
Duration of response (DOR)	Up to 31 months
Progression-free survival (PFS)	Up to 31 months

Trial Locations

Locations (91)

The First Affiliated Hospital of Xian Jiaotong University; 🇨🇳 Xian, Shaanxi, China

Hospital of Lithuanian University of Health Sciences Kaunas Clinics Branch Oncology Hospital; 🇱🇹 Kaunas, Lithuania

Health Pharma Professional Research Sa de Cv; 🇲🇽 Ciudad de Mexico, Mexico

Investigacion Onco Farmaceutica (Oncotech); 🇲🇽 La Paz, Mexico

Fundacion Rodolfo Padilla Padilla, Ac; 🇲🇽 Leon, Mexico

Medica Sur; 🇲🇽 Mexico, Mexico

Accelerium S de Rl de Cv; 🇲🇽 Monterrey, Mexico

Oaxaca Site Management Organization Sc; 🇲🇽 Oaxaca, Mexico

Cancer Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

The Affiliated Hospital of Zunyi Medical College; 🇨🇳 Zunyi, Guizhou, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Changsha Central Hospital; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Xuzhou Central Hospital; 🇨🇳 Xuzhou, Jiangsu, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Goztepe Prof Dr Suleyman Yalcin Ehir Hastanesi; 🇹🇷 Istanbul, Turkey

Necmettin Erbakan University Selcuklu Faculty of Medicine; 🇹🇷 Meram, Turkey

Iu C, Clinical Research Excellence Application and Research Center; 🇹🇷 Stanbul, Turkey

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Cancer Center of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Hospital de Amor Barretos; 🇧🇷 Barretos, Brazil

Hospital Evangelico de Cachoeiro de Itapemirim; 🇧🇷 Cachoeiro de Itapemirim, Brazil

Oncosite Centro de Pesquisa Clinica Em Oncologia; 🇧🇷 Ijui, Brazil

Fundacao Doutor Amaral Carvalho; 🇧🇷 Jau, Brazil

Liaoning Cancer Hospital and Institute; 🇨🇳 Shenyang, Liaoning, China

Inca Instituto Nacional de Cancer; 🇧🇷 Rio de Janeiro, Brazil

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto AlegreRS, Brazil

Nob Nucleo de Oncologia Da Bahia; 🇧🇷 Salvador, Brazil

Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia; 🇧🇷 Santo Andre, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto; 🇧🇷 Sao Jose do Rio Preto, Brazil

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira; 🇧🇷 Sao Paulo, Brazil

Mhat Dr Tota Venkova, Ad; 🇧🇬 Gabrovo, Bulgaria

Acibadem City Clinic Mhat Tokuda Ead; 🇧🇬 Sofia, Bulgaria

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Chinese Pla General Hospital; 🇨🇳 Beijing, Beijing, China

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China

Hainan General Hospital; 🇨🇳 Haikou, Hainan, China

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Nantong Tumor Hospital Branch North; 🇨🇳 Nantong, Jiangsu, China

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Jiangxi Province Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China

Fakultna Nemocnica S Poliklinikou Fd Roosevelta; 🇸🇰 Banska Bystrica, Slovakia

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital; 🇨🇳 Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Zhejiang University College of Medicine Second Affiliated Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Nemocnica Na Okraji Mesta, No; 🇸🇰 Partizanske, Slovakia

Poko Poprad Sro; 🇸🇰 Poprad, Slovakia

Nonu Universitesi Tip Fakultesi; 🇹🇷 Battalgazi, Turkey

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital; 🇹🇷 Istanbul, Turkey

Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna; 🇵🇱 Lodz, Poland

Salve Medica Sp Z Oo, Sp Komandytowa; 🇵🇱 Lodz, Poland

Zespol Gruzlicy I Chorob Pluc W Olsztynie Oddz Onkologii Z Pododdz Chemioterapii Nowotworow Puc; 🇵🇱 Olsztyn, Poland

Arkhangelsk Regional Clinical Oncological Dispensary; 🇷🇺 Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation

Fsbi of Higher Educationogarev Mordovia State University; 🇷🇺 Saransk, Mordoviya, Respublika, Russian Federation

N N Blokhin Russian Cancer Research Center Konstantin Laktionov; 🇷🇺 Moscow, Moskva, Russian Federation

Vitamed Llc; 🇷🇺 Moscow, Moskva, Russian Federation

Bih of Omsk Region Clinical Oncology Dispensary; 🇷🇺 Omsk, Omskaya Oblast', Russian Federation

Private Medical Institution Evromedservis; 🇷🇺 Pushkin, Sankt-Peterburg, Russian Federation

Llc Center of Palliative Medicine Devita; 🇷🇺 SaintPetersburg, Sankt-Peterburg, Russian Federation

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

Linyi Cancer Hospital; 🇨🇳 Linyi, Shandong, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China

Hospital of Lithuanian University of Health Sciences Kaunas Clinics; 🇱🇹 Kaunas, Lithuania

National Cancer Institute; 🇱🇹 Vilnius, Lithuania

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Waikato Hospital; 🇳🇿 Hamilton Waikato, New Zealand

Tauranga Hospital; 🇳🇿 Tauranga, New Zealand

Irkutsk Regional Oncology Dispensary; 🇷🇺 Irkutsk, Irkutiskaya Oblast', Russian Federation

Pavlov First Saint Petersburg State Medical University; 🇷🇺 SaintPetersburg, Sankt-Peterburg, Russian Federation

Acibadem Adana Hospital; 🇹🇷 Adana, Turkey

Hacettepe University; 🇹🇷 Ankara, Turkey

Kocaeli Universitesi Tip Fakultesi; 🇹🇷 Kocaeli, Turkey

Namik Kemal University; 🇹🇷 Tekirdag, Turkey