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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
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Confirmed overall response rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+2 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
~5810
Nab paclitaxel
2014
Completed Phase 2
~580
Tislelizumab
2018
Completed Phase 3
~4560
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~2360
pemetrexed
2005
Completed Phase 3
~5000
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Who is running the clinical trial?
BeiGeneLead Sponsor
188 Previous Clinical Trials
29,685 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,252 Previous Clinical Trials
503,979 Total Patients Enrolled
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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 1: Experimental Arm 3A
- Group 2: Sub-study 1: Reference Arm Tislelizumab alone
- Group 3: Sub-study 2: Experimental Arm 2B
- 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.
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