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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug and chemotherapy combo to treat lung cancer, depending on how much of a certain protein is expressed.
Who is the study for?
This trial is for adults with advanced or recurrent non-small cell lung cancer (NSCLC) that can't be treated with surgery. They should not have had prior treatments for metastatic NSCLC, must have a performance status showing they're mostly active and able to care for themselves, and at least one measurable tumor lesion. Patients are divided based on their tumor's PD-L1 protein levels.Check my eligibility
What is being tested?
The study tests the effectiveness of Tislelizumab combined with other investigational drugs and possibly chemotherapy in treating NSCLC. It has two parts: one part includes patients whose tumors express high levels of PD-L1 protein, while the other involves those with low or no expression of this protein.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug administration process, fatigue, potential blood disorders, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed overall response rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+9 moreTrial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Sub-study 2: Experimental Arm 3BExperimental Treatment7 Interventions
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025
Group II: Sub-study 2: Experimental Arm 2BExperimental Treatment7 Interventions
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007
Group III: Sub-study 2: Experimental Arm 1BExperimental Treatment8 Interventions
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445
Group IV: Sub-study 1: Reference Arm Tislelizumab aloneExperimental Treatment1 Intervention
Tislelizumab alone
Group V: Sub-study 1: Experimental Arm 3AExperimental Treatment2 Interventions
Tislelizumab + BGB-15025
Group VI: Sub-study 1: Experimental Arm 2AExperimental Treatment2 Interventions
Tislelizumab + LBL-007
Group VII: Sub-study 1: Experimental Arm 1AExperimental Treatment2 Interventions
Tislelizumab + BGB-A445
Group VIII: Sub-study 2: Reference ArmActive Control6 Interventions
Tislelizumab + investigator's choice of histology-appropriate chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Cisplatin
2013
Completed Phase 3
~1940
pemetrexed
2005
Completed Phase 3
~5000
Nab paclitaxel
2014
Completed Phase 2
~70
Tislelizumab
2018
Completed Phase 3
~4260
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,425 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,211 Previous Clinical Trials
488,872 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor has been tested for PD-L1 and shows expression.My lung cancer is advanced, cannot be cured by surgery or chemoradiotherapy, and may have spread.My cancer has a mutation that can be treated with specific drugs.I am fully active or can carry out light work.I haven't taken any Chinese herbal or patent medicines for cancer in the last 14 days.I've had treatments targeting immune checkpoints but have been treatment-free for 6 months.I do not have active brain metastasis, leptomeningeal disease, or uncontrolled autoimmune diseases.My lung cancer is a mix of small cell and non-small cell types.I haven't received systemic treatment for metastatic NSCLC, but may have had chemotherapy or radiotherapy for local disease over 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-study 2: Experimental Arm 2B
- Group 2: Sub-study 1: Reference Arm Tislelizumab alone
- Group 3: Sub-study 1: Experimental Arm 3A
- Group 4: Sub-study 2: Experimental Arm 3B
- Group 5: Sub-study 1: Experimental Arm 1A
- Group 6: Sub-study 1: Experimental Arm 2A
- Group 7: Sub-study 2: Experimental Arm 1B
- Group 8: Sub-study 2: Reference Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study actively seeking participants at the current time?
"According to clinicaltrials.gov, this investigation is actively recruiting participants. The original listing was published on March 7th 2023 and the most recent edit was made on May 22nd of that same year."
Answered by AI
What is the aggregate count of participants in this investigation?
"To complete this clinical trial, BeiGene needs to enrol 200 patients that meet the study's criteria. The investigation will be conducted in multiple locations such as Northern Beaches Hospital in Frenchs Forest, New South Wales and Port Macquarie Base Hospital in Port Macquarie,, Shanghai."
Answered by AI
What adverse effects could potentially arise from Sub-study 1: Experimental Arm 1A?
"Our team's assessment of the safety of Sub-study 1: Experimental Arm 1A is a 2 due to it being in Phase 2, which indicates data attesting to its security but not establishing efficacy."
Answered by AI
Are there any locations in the US where this experiment is taking place?
"Currently, there are 5 trial sites enrolling patients. These locations include Frenchs Forest, Port Macquarie, and Shanghai amongst a few others. To reduce travel costs associated with participation in this study, it is encouraged to select the centre closest to you for convenience."
Answered by AI
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