Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03256136
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2017-08-17
Brief Title:
Nivolumab in Combination With Chemotherapy or Nivolumab in Combination With Ipilimumab in Advanced EGFR-Mutant or ALK-Rearranged NSCLC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Study of Nivolumab in Combination With Carboplatin and Pemetrexed or Nivolumab in Combination With Ipilimumab in Patients With Advanced EGFR-mutant or ALK-rearranged Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is studying a drug intervention as a possible treatment for lung cancer
The drugs involved in this study are
Nivolumab
Carboplatin
Pemetrexed
Ipilimumab
The drugs involved in this study are
Nivolumab
Carboplatin
Pemetrexed
Ipilimumab
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease
The FDA the US Food and Drug Administration has approved Nivolumab as a treatment for other types of cancers including lung cancer However the combination of Nivolumab with other drugs such as those being tested in this study has not been approved by the FDA as a treatment for this type of lung cancer
The purpose of this study is to test the effectiveness how well the drug works safety and tolerability of the drug Nivolumab in combination with standard of care chemotherapies or in combination with Ipilimumab Nivolumab and Ipilimumab are antibodies a type of human protein that are being tested to see if they will allow the bodys immune system to work against tumor cells This study is being done to see if Nivolumab and Ipilimumab or Nivolumab and chemotherapy drugs Carboplatin and Pemetrexed are more effective against cancer when administered together
These drugs are given as infusions They are designed to boost the immune systems ability to suppress or kill cancer cells that are foreign to the human body
The FDA the US Food and Drug Administration has approved Nivolumab as a treatment for other types of cancers including lung cancer However the combination of Nivolumab with other drugs such as those being tested in this study has not been approved by the FDA as a treatment for this type of lung cancer
The purpose of this study is to test the effectiveness how well the drug works safety and tolerability of the drug Nivolumab in combination with standard of care chemotherapies or in combination with Ipilimumab Nivolumab and Ipilimumab are antibodies a type of human protein that are being tested to see if they will allow the bodys immune system to work against tumor cells This study is being done to see if Nivolumab and Ipilimumab or Nivolumab and chemotherapy drugs Carboplatin and Pemetrexed are more effective against cancer when administered together
These drugs are given as infusions They are designed to boost the immune systems ability to suppress or kill cancer cells that are foreign to the human body
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None