Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643117
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Similar Efficacy Safety and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Double-blind Trial to Demonstrate Similar Efficacy Safety and Immunogenicity of FYB206 Keytruda Biosimilar Candidate in Comparison to Keytruda Pembrolizumab as an Add-on to Chemotherapy in Treatment-naïve Patients With Metastatic Non-squamous Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lotus
Brief Summary:
NSCLC is the most common type of lung cancer Metastatic cancers are cancers that start to spread to other parts of the body NSCLC is treated by radiation therapy with medicines surgery or immunotherapy Immunotherapy is a type of treatment that helps the immune system fight cancer
The immune system helps the body fight infections and disease Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells Some cancer cells develop a way to hide from the bodys immune system and thus allow the cancer cells to spread and grow Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide Pembrolizumab is a biologic drug produced by living organisms available in the market under the brand name Keytruda Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery This helps prevent the cancer from returning improving overall survival
FYB206 is a proposed biosimilar to Keytruda A biosimilar is not identical but very similar to its original biologic Biosimilars are expected to have a similar effect and safety to the original biologic This clinical trial is intended to demonstrate the comparable effectiveness and safety of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC who have not received previous anti-cancer treatment that is given directly into the blood
The immune system helps the body fight infections and disease Pembrolizumab is an anti-cancer therapy that works with the immune system to fight cancer cells Some cancer cells develop a way to hide from the bodys immune system and thus allow the cancer cells to spread and grow Pembrolizumab helps the immune system recognize and kill these cancer cells that want to hide Pembrolizumab is a biologic drug produced by living organisms available in the market under the brand name Keytruda Keytruda is approved globally for the treatment of a variety of cancers and as an addon or after therapy to primary cancer treatment like surgery This helps prevent the cancer from returning improving overall survival
FYB206 is a proposed biosimilar to Keytruda A biosimilar is not identical but very similar to its original biologic Biosimilars are expected to have a similar effect and safety to the original biologic This clinical trial is intended to demonstrate the comparable effectiveness and safety of FYB206 to Keytruda as an add-on treatment to chemotherapy in patients with metastatic NSCLC who have not received previous anti-cancer treatment that is given directly into the blood
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None