Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
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| ClinicalTrials.gov Identifier: NCT04379635 |
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Recruitment Status :
Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : March 2, 2023
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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Brief Summary:
The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: Tislelizumab Drug: Cisplatin injection Drug: Paclitaxel injection Drug: Pemetrexed Disodium Drug: Placebos Drug: Carboplatin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 453 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer |
| Actual Study Start Date : | May 29, 2020 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | November 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
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Drug: Tislelizumab
administered via Intravenous (IV) injection
Other Name: BGB-A317 Drug: Cisplatin injection administered via IV infusion Drug: Paclitaxel injection administered via IV infusion Drug: Pemetrexed Disodium administered via IV infusion Drug: Carboplatin administered via IV infusion |
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Placebo Comparator: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
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Drug: Cisplatin injection
administered via IV infusion Drug: Paclitaxel injection administered via IV infusion Drug: Pemetrexed Disodium administered via IV infusion Drug: Placebos Placebo to match tislelizumab IV infusion Drug: Carboplatin administered via IV infusion |
Primary Outcome Measures :
- Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set [ Time Frame: Up to 3 months following completion of neoadjuvant treatment ]
- Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR) [ Time Frame: Up to 5 years ]
Secondary Outcome Measures :
- Overall survival (OS) in the ITT set [ Time Frame: Up to 5 years ]
- Pathological complete response (pCR) rate [ Time Frame: Up to 5 years ]
- Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
- Disease-Free Survival (DFS) in ITT analysis set [ Time Frame: Up to 5 years ]
- Event-free survival (EFS) Assessed by the Investigator [ Time Frame: Up to 5 years ]
- Number of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5 years ]
- Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire [ Time Frame: Up to 5 years ]
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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
Key Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histologically confirmed Stage II or IIIA NSCLC
- Measurable disease as assessed per RECIST v1.1
- Confirm eligibility for an R0 resection with curative intent
Key Exclusion Criteria:
- Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
- Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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): NCT04379635
Locations
Show 48 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Principal Investigator: | Changli Wang, MD | Tianjin Medical University Cancer Institute and Hospital |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT04379635 |
| Other Study ID Numbers: |
BGB-A317-315 CTR20200821 ( Registry Identifier: ChiCTR ) |
| First Posted: | May 7, 2020 Key Record Dates |
| Last Update Posted: | March 2, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | 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 Paclitaxel Carboplatin |
Pemetrexed Tislelizumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Immunological |