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 |
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Recruitment Status :
Recruiting
First Posted : December 2, 2017
Last Update Posted : June 29, 2018
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
- Study Details
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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 |
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
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Docetaxel
| Arm | Intervention/treatment |
|---|---|
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Experimental: BGB-A317
BGB-A317, 100 mg per vial, 200mg IV, Q3W
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Drug: BGB-A317
Intravenous injection |
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Experimental: Docetaxel
Docetaxel 75 mg/m2 IV Q3W
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Drug: Docetaxel
Intravenous injection |
Primary Outcome Measures :
- Overall survival (OS) [ Time Frame: Up to 34 months ]
Secondary Outcome Measures :
- Objective response rate(ORR) [ Time Frame: Up to 34 months ]
- Duration of response (DOR) [ Time Frame: Up to 34 months ]
- Progression-free survival (PFS) [ Time Frame: Up to 34 months ]
- Health-related Quality of Life(HRQoL) [ Time Frame: Up to 34 months ]
- 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.
- Age18 years.
- Signed Informed Consent Form.
- 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.
- Subjects must be able to provide fresh or archival tumor tissues for central assessment of PD-L1 expression in tumor cells.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate hematologic and end-organ function.
Exclusion Criteria:
- Prior therapies of docetaxel or treatment targeting PD-1, PD-L1 or CTLA-4.
- Harboring EGFR sensitizing mutation or ALK gene translocation.
- 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.
- History of severe hypersensitivity reactions to other mAbs.
- History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
- With uncontrollable pleural effusion, pericardial effusion, or clinically significant ascites requiring interventional treatment.
- Diagnosis of other malignancies with some exceptions.
- Active infection requiring systemic treatment, known HIV infection, subjects with untreated chronic hepatitis B or chronic HBV, active vaccination treatment.
- Insufficient cardiac functions and other underlying unfavorable conditions.
- Prior allogeneic stem cell transplantation or organ transplantation.
- 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:
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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 |