Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-03 @ 2:35 AM
Study NCT ID:
NCT03292133
Status:
TERMINATED
Last Update Posted:
2025-06-10
First Post:
2017-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Phase 2 Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 combination of drugs as a possible treatment for EGFR mutation-positive lung cancer.
The drugs involved in this study are:
* EGF816
* Gefitinib
The drugs involved in this study are:
* EGF816
* Gefitinib
Detailed Description:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease or patient population. "Investigational" means that the drug or drugs are being studied and have not been approved together for patients.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option for EGFR mutation-positive lung cancer.
The FDA has not approved EGF816 as a treatment for any disease at this time.
In this research study, the investigators are studying the safety and efficacy of the combination of the study drugs EGF816 and gefitinib.
Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may stop tumors growing and multiplying.
The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option for EGFR mutation-positive lung cancer.
The FDA has not approved EGF816 as a treatment for any disease at this time.
In this research study, the investigators are studying the safety and efficacy of the combination of the study drugs EGF816 and gefitinib.
Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may stop tumors growing and multiplying.
Study Oversight
Has Oversight DMC:
True
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?: