400 Participants Needed

Tislelizumab + Chemotherapy for Lung Cancer

Recruiting at 91 trial locations
B
Overseen ByBeiGene
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before joining the trial.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before joining the trial.

What safety data is available for Tislelizumab plus chemotherapy in lung cancer treatment?

Tislelizumab, an anti-PD-1 monoclonal antibody, has been evaluated for safety in various studies. It has an acceptable safety profile with common adverse effects including fatigue, anemia, and decreased neutrophil count. Serious adverse events have included respiratory infection or failure, and hepatic injury. In a study on urothelial carcinoma, the most common treatment-related adverse events were anemia (27%) and pyrexia (19%), with anemia (7%) and hyponatremia (5%) being the only grade 3-4 events occurring in ≥ 5% of patients. Three deaths were possibly related to the treatment. Overall, Tislelizumab has shown a manageable safety profile in clinical trials.12345

Is the combination of Tislelizumab and chemotherapy safe for treating lung cancer?

Tislelizumab, when used alone or with chemotherapy, has shown an acceptable safety profile in treating various cancers, including lung cancer. Common side effects include fatigue, anemia (low red blood cell count), and decreased neutrophil count (a type of white blood cell), while serious risks involve respiratory infections or liver damage. Overall, it is considered manageable in terms of safety.12345

Is the drug Tislelizumab a promising treatment for lung cancer?

Yes, Tislelizumab is a promising drug for lung cancer. It is designed to work with the body's immune system to fight cancer cells more effectively. Studies show that when combined with chemotherapy, it can improve outcomes for patients with advanced lung cancer.13678

What makes the drug Tislelizumab unique for lung cancer treatment?

Tislelizumab is unique because it is an anti-PD-1 monoclonal antibody specifically engineered to reduce binding to certain receptors on immune cells, which helps prevent the immune system from clearing T-cells that fight cancer. This design aims to improve its effectiveness in treating non-small cell lung cancer when combined with chemotherapy.13678

What data supports the idea that Tislelizumab + Chemotherapy for Lung Cancer is an effective treatment?

The available research shows that Tislelizumab, when combined with chemotherapy, may improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy alone. Specifically, the RATIONALE 304 trial suggests that this combination could lead to better results for patients with advanced nonsquamous NSCLC. This indicates that adding Tislelizumab to chemotherapy might be more effective than using chemotherapy by itself.13679

What data supports the effectiveness of the drug Tislelizumab + Chemotherapy for Lung Cancer?

Research shows that Tislelizumab, when combined with chemotherapy, may improve outcomes for patients with advanced non-small cell lung cancer compared to chemotherapy alone. Tislelizumab is designed to enhance the immune system's ability to fight cancer by targeting a specific protein (PD-1) that helps cancer cells evade immune detection.13679

Who Is on the Research Team?

SD

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

At least 1 measurable lesion as defined per RECIST v1.1
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.
See 2 more

Exclusion Criteria

My cancer has a mutation that can be treated with specific drugs.
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.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tislelizumab in combination with investigational agents with or without chemotherapy

Up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • BGB-A445
  • Carboplatin
  • Cisplatin
  • LBL-007
  • Nab paclitaxel
  • Paclitaxel
  • Pemetrexed
  • Tislelizumab
Trial Overview 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.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Active Control
Group I: Sub-study 2: Arm 3BExperimental Treatment7 Interventions
Group II: Sub-study 2: Arm 2BExperimental Treatment7 Interventions
Group III: Sub-study 2: Arm 1BExperimental Treatment7 Interventions
Group IV: Sub-study 1: Arm 3AExperimental Treatment2 Interventions
Group V: Sub-study 1: Arm 2AExperimental Treatment2 Interventions
Group VI: Sub-study 1: Arm 1AExperimental Treatment2 Interventions
Group VII: Sub-study 1: Reference Arm Tislelizumab aloneActive Control1 Intervention
Group VIII: Sub-study 2: Reference ArmActive Control6 Interventions

BGB-A445 is already approved in European Union, United States, China for the following indications:

🇪🇺
Approved in European Union as Tevimbra for:
🇺🇸
Approved in United States as Tevimbra for:
🇨🇳
Approved in China as Tevimbra for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials
216
Recruited
32,500+

Published Research Related to This Trial

Tislelizumab, an anti-PD-1 monoclonal antibody, shows promising efficacy and a manageable safety profile in treating advanced non-small cell lung cancer (NSCLC), with higher affinity to PD-1 compared to other similar therapies like pembrolizumab and nivolumab.
The drug's unique design minimizes binding to macrophages, potentially reducing resistance to treatment, and ongoing trials are exploring its effectiveness in combination with other therapies, which could enhance its role in clinical practice.
Tislelizumab: an investigational anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer (NSCLC).Liu, SY., Wu, YL.[2022]
In a phase IA/IB study involving 451 patients with advanced solid tumors, tislelizumab demonstrated an acceptable safety profile, with most adverse events being mild (grade 1-2), and only 5.3% of patients discontinuing treatment due to side effects.
Tislelizumab showed promising antitumor activity, with 18% of patients in phase IA and 12% in phase IB achieving confirmed objective responses, leading to the recommendation of a dosing schedule of 200 mg every 3 weeks for future trials.
Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors.Desai, J., Deva, S., Lee, JS., et al.[2021]
Tislelizumab, an anti-PD-1 monoclonal antibody, shows improved progression-free survival and objective response rates in treating non-small cell lung cancer (NSCLC), especially when combined with chemotherapy, based on a review of four randomized controlled trials involving 1565 patients.
While tislelizumab is generally effective, it is associated with treatment-emergent adverse events, including significant hematologic issues and immune-mediated effects like hypothyroidism and pneumonitis, with a mortality rate from these events ranging from 3.2% to 4.2%.
The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials.Daei Sorkhabi, A., ZareDini, M., Fazlollahi, A., et al.[2023]

Citations

Tislelizumab: an investigational anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer (NSCLC). [2022]
Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. [2021]
The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials. [2023]
Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. [2023]
Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. [2021]
Safety and efficacy of tislelizumab plus chemotherapy as preoperative treatment in potentially resectable locally advanced non-small cell lung cancer patients. [2023]
Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. [2023]
Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma. [2022]
Tislelizumab for cervical cancer: A retrospective study and analysis of correlative blood biomarkers. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security