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

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Chen Cao	+86 10 5895 8000	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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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