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

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ClinicalTrials.gov Identifier: NCT03358875
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
The purpose of this study is to show that BGB-A317 will improve overall survival in subjects with Stage IIIB or IV non-small cell lung cancer when compared to docetaxel in second or third-line treatment setting.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: BGB-A317 Drug: Docetaxel Phase 3

Detailed Description:
This is a randomized, open-label, multicenter Phase 3 study in adult patients 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: BGB-A317
BGB-A317, 100 mg per vial, 200mg IV, Q3W
Drug: BGB-A317
Intravenous injection

Experimental: Docetaxel
Docetaxel 75 mg/m2 IV Q3W
Drug: Docetaxel
Intravenous injection




Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 34 months ]

Secondary Outcome Measures :
  1. Objective response rate(ORR) [ Time Frame: Up to 34 months ]
  2. Duration of response (DOR) [ Time Frame: Up to 34 months ]
  3. Progression-free survival (PFS) [ Time Frame: Up to 34 months ]
  4. Health-related Quality of Life(HRQoL) [ Time Frame: Up to 34 months ]
  5. Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI-CTCAE, v4.03. [ Time Frame: Up to 34 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Able to provide written informed consent and can understand and comply with the requirements of the study.

  1. Age18 years.
  2. Signed Informed Consent Form.
  3. Histologically confirmed locally advanced or metastatic (Stage IIIB or IV) NSCLC with disease progression during or following treatment with at least one platinum-containing regimen, but no more than 2 lines of systemic therapy.
  4. Subjects must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  6. Adequate hematologic and end-organ function.

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 acute effects of prior therapy of Grade 2-5, except for AEs (e.g. alopecia, neuropathy, specific lab abnormalities) not constituting a likely safety risk.
  4. History of severe hypersensitivity reactions to other mAbs.
  5. History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
  6. With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
  7. Diagnosis of other malignancies with some exceptions.
  8. Active infection requiring systemic treatment, known HIV infection, subjects with untreated chronic hepatitis B or chronic HBV, active vaccination treatment.
  9. Insufficient cardiac functions and other underlying unfavorable conditions.
  10. Prior allogeneic stem cell transplantation or organ transplantation.
  11. Active autoimmune diseases or history of autoimmune diseases that may relapse should be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358875


Contacts
Contact: Chen Cao clinicaltrials@beigene.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Ziping WANG    8613301212676    wangzp2007@126.com   
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Yi HU    8613911031186    huyi0401@aliyun.com   
Beijing Chest Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 101149
Contact: Zhe LIU    8613651392121    lza@vip.163.com   
China, Heilongjiang
Harbin Medical University Cancer Hospital Not yet recruiting
Harbin, Heilongjiang, China, 150081
Contact: Yan YU    8613904505825    gpyuyan@163.com   
China, Liaoning
The First Hospital of China Medical University Not yet recruiting
Shenyang, Liaoning, China, 110001
Contact: Yunpeng LIU    8613898865122    cmu_trial@163.com   
China, Shanghai
Shanghai Pulmonary Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Caicun ZHOU    8613301825532    caicunzhoudr@163.com   
China, Tianjin
Tianjin Cancer Hospital Not yet recruiting
Tianjin, Tianjin, China, 300060
Contact: Dingzhi HUANG    8613116047308    ec_tjich@126.com   
China, Zhejiang
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xinmin YU    8613705718617    2231295153@qq.com   
Sponsors and Collaborators
BeiGene

Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03358875     History of Changes
Other Study ID Numbers: BGB-A317-303
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antibodies
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs