Tislelizumab + Chemotherapy for Lung Cancer
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?
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Tislelizumab in combination with investigational agents with or without chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BGB-A445
- Carboplatin
- Cisplatin
- LBL-007
- Nab paclitaxel
- Paclitaxel
- Pemetrexed
- Tislelizumab
BGB-A445 is already approved in European Union, United States, China for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor