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Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04379635
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 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 : February 2023
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium on Day 1 of each cycle for up to a total of 12 cycles
Drug: Tislelizumab
200/400 mg administered via Intravenous (IV) injection on Day 1, given every 21 or 42 days depending on dosing
Other Name: BGB-A317

Drug: Cisplatin injection
75 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Paclitaxel injection
175 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Pemetrexed Disodium
500 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Carboplatin
Area under the curve (AUC) of 5 mg/mL/min administered via IV infusion Day 1, given every 21 days

Placebo Comparator: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium on Day 1 of each cycle for up to a total of 12 cycles
Drug: Cisplatin injection
75 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Paclitaxel injection
175 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Pemetrexed Disodium
500 mg/m^2 administered via IV infusion on Day 1, given every 21 days

Drug: Placebos
Placebo to match tislelizumab IV infusion

Drug: Carboplatin
Area under the curve (AUC) of 5 mg/mL/min administered via IV infusion Day 1, given every 21 days




Primary Outcome Measures :
  1. Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set [ Time Frame: Up to 3 months following completion of neoadjuvant treatment ]
  2. 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 :
  1. Overall survival (OS) in the ITT set [ Time Frame: Up to 5 years ]
  2. Pathological complete response (pCR) rate [ Time Frame: Up to 5 years ]
  3. Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
  4. Disease-Free Survival (DFS) in ITT analysis set [ Time Frame: Up to 5 years ]
  5. Event-free survival (EFS) Assessed by the Investigator [ Time Frame: Up to 5 years ]
  6. Number of participants experiencing treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 5 years ]
  7. Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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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:

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  2. Histologically confirmed Stage II or IIIA NSCLC
  3. Measurable disease as assessed per RECIST v1.1
  4. Confirm eligibility for an R0 resection with curative intent

Key Exclusion Criteria:

  1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
  2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
  3. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse
  5. 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


Contacts
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Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 41 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Changli Wang, MD Tianjin Medical University Cancer Institute and Hospital
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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: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
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